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Family and Preventive Medicine

July 26th, 2018 3:43 pm

The Department of Family and Preventive Medicine (DFPM) supports superb educational and research divisions.

Residency Program The Little Rock Family Medicine Residency Program teachesthe Family Medicine physicians of tomorrow. We offer excellenttrainingin apremieracademic medicalcenterin the states capital city, along with outstanding rotations at Arkansas Childrens Hospital and the John McClellan Veterans Administration Hospital. Our residents enjoy superior procedural training that includes screening colonoscopies, dermatological procedures, and musculoskeletal procedures. Another focus is psychosocial development.

Research and Evaluation Division (RED) RED focuses on family and environmental factors linked with poor health, growth, and psychosocial development of children. Weconduct research to test theoretical models, collaborate with community partners to implement and evaluate programs, train on research-based models, and translate those models into community settings.

Community Health and Education (CHE) We provide family physicians, nurses, pharmacists and other healthcare professionals with the highest caliber of continuing education, specific to Family Medicine. Our goal is to equip our audience with the tools they can use in their practice immediately. A secondary goal is to train the community in how to maintain healthier lifestyles.

Medical Student Education Division The mission of the Medical Student Education divisionis to provide high quality Family Medicine educational opportunities, including clerkships for undergraduate students.

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Family and Preventive Medicine

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Integrative Medicine & Health | UK HealthCare

July 26th, 2018 3:42 pm

We offer a broad range of services that can be used alone or together to meet the needs of the individual. Whether you are managing the side effects of a chronic condition, seeking pain relief or just looking for ways to enhance your healthy lifestyle, our Integrative Medicine & Health providers will work with you to select the classes and therapy sessions that are right for you. The services we offer are:

Registered therapy animals and their handlers work together to integrate animal interactions into health, education and human services for the purpose of therapeutic improvements and enriched health and wellness.

Often used in combination with massage and other therapeutic techniques as part of an integrative treatment approach, aromatherapy is the therapeutic use of plant-derived, aromatic essential oils to promote physical and psychological well-being.

Art therapy uses the creative process of making art to improve a persons physical, mental and emotional health. Under the direction of a licensed art therapist, art expression is a non-verbal way to communicate thoughts, feelings, experiences and imagination, resulting in reduced stress, pain relief and personal insight.

Jin Shin Jyutsu uses the power of light touch on the body through clothing to assist with pain, stress, nausea, and other physical and emotional side effects of chronic conditions and illness.

Massage therapy is the manual manipulation of soft body tissues to enhance health and well-being. Massage sessions include therapeutic, relaxation, prenatal and oncology massages, which are tailored to meet patients individual needs.

Guided meditation can help reduce stress, support immune health, increase happiness, improve productivity and calm the mind.

Music therapy is the evidence-based use of music interventions to address the physical, emotional, cognitive, social and spiritual needs of patients of all ages. A music therapy session with a board-certified music therapist may include patient-preferred music, lyric analysis, instrument playing, singing, songwriting, or music and imagery.

Narrative medicine sessions encourage patients to rediscover personal identity and meaning by telling or writing their stories. Patients are invited to share their life experiences, sources of strength, new insights or perspectives during illness or treatment, and hopes for the future.

Regardless of faith or religious affiliation, pastoral care is available to patients, family and staff at all times to help deal with the spiritual and emotional challenges associated with medical events and crises.

Reiki is a non-invasive Japanese healing practice that involves the placement of hands above or gently on the body, using life-force energy to facilitate relaxation and stress reduction and to promote healing.

Often called moving meditation, tai chi is a Chinese martial art that combines a variety of slow, gentle movements, standing postures and deep breathing to focus the bodys energy and align mind, body and spirit.

Yoga is an effective mind-body practice incorporating gentle movement, breathing and deep relaxation techniques to reduce stress, pain and fatigue. These techniques also promote positive physical, mental and emotional changes. Yoga classes are suitable for all skill levels.

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Integrative Medicine: About | Cleveland Clinic

July 26th, 2018 3:42 pm

Overview

Integrative Medicine techniques support the body's natural ability to heal, reducing stress and promoting a state of relaxation that leads to better health. It can help you achieve optimal health when you engage in your own healing and feel empowered to make lifestyle changes. Incorporating one or more Integrative Medicine services into your healthcare regimen will help you regain control of your well-being.

Integrative Medicine uses modalities such as acupuncture, chiropractic manipulation and relaxation techniques to reduce pain; dietary and herbal approaches to manage diseases such as diabetes and fibromyalgia; and group support to change habits associated with obesity, diabetes and heart disease.

Lifestyle Medicine is an evidence-based practice of assisting individuals and families adopt and sustain lifestyle behaviors that can improve your health and quality of life, such as eliminating tobacco use, improving diet, practicing stress relief techniques, and increasing physical activity. Poor lifestyle choices are the root cause of modern chronic diseases. Scientific evidence is clear - adults with common chronic conditions who adhere to a healthy lifestyle experience rapid, significant, clinically meaningful and sustainable improvements in their health.

The practices, techniques and services offered that most patients find helpful include:

Medical consults and several complementary therapies are now offered via an online appointment called Cleveland Clinic Express Care (or Virtual Visits). To make an appointment or learn more about any of these services, call 216.448.4325 option 4.

Integrative & Lifestyle Medicine services have become very popular in the United States, with more than 70 percent of Americans using them in some form.

You may benefit from Integrative & Lifestyle Medicine if you suffer from a chronic illness and wish to reduce the severity or frequency of disease episodes, decrease stress related to chronic disease, and enjoy a better quality of life.

Integrative & Lifestyle Medicine can help patients relieve symptoms of a wide range of conditions, including:

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Integrative Medicine: About | Cleveland Clinic

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Grow Taller Using Stem Cells , Part I – Natural Height Growth

July 25th, 2018 5:45 pm

Of all of the possible techniques and strategies that can lead us as a species to find a way to increase our size, the advent of stem cells is one of the most promising ideas.In this post, I wanted to give a very general and brief introduction to our journey into the subject of stem cells to search for a solution to our height increase endeavor. This first post will definitely wont be the last post on this subject since there is so much research currently being done in this subject to look for solutions to some of our biggest medical and cosmetic problems we face in our modern era.

If we remember from our high school or college biology classes, we might remember that we all came from the zygotic formation brought by the male gamete the sperm coming into fusion with the female gamete the egg. From this initial single organism zygote we are slowly developed into something resembling a human baby in our mothers uterus. The curous person would be asking the question Just how exactly does the zygote figure out how to grow and develop into the product of a human baby? That comes from the instructions in the cell called DNA. DNA stand for deoxyribonucleic acid, which is a double helix structure which has at its most basic level only 4 types of nucleotides bases being repeated and sorted in a certain order. From the way the nucleotide bases are set up, we get our codons, which organize themselves to form genes. the genes are really just segments of biological instruction ,or information. The information is what really tells the cells what to do. That is where almost all of genetics and the study of stem cells begins.

The stem cell is a type of cell which can differentiate itself and transform into another type of cell which has a specialized function as well as self generate more of itself. The ability of the stem cell to turn into so many different types of cells allows its application into the medical sciences to be nearly endless. If we can get certain stem cells to regrow into the tyep fo tissues and even organs that we wnat, we can essentially treat our body like a car, where if a specific part is damaged or not functioning, we can go into out body and replace the damaged tissue from the stem cell derived results.

If we look at the diagram to our left we can see just what types of diseases and pathologies stem cells therapy can potentially treat. Some of the possibilities can seem to come from science fiction.

Stroke, Baldness, Blindness, Learning Defects, Deafness Alzheimers disease, Parkinsons Disease, Missing Teeth, Teeth cavitations, Wond healing, Brain Injuries, Amyotrophic lateral sclerosis, Myocardial Infarction, Muscular Dystrophy, Diabetes, Bone marrow transplantation, Spinal cord injury, Multiple types of cancer, Osteoarthiritis, Crohns Disease.

It would seem from this list that our desire to use stem cells to increase our height seems almost insignificant when we consider what other applications stem cell therapies can be used for. It is a real shame the the US government and scientific community has been slow or even against the research of stem cell therapy. What often has to happen is that if a person suffering from a specific pathology wanted to use stem cell therapy as treatment, they have to leave the US and get it somewhere else.I dont have a Ph. D so I dont feel like I am qualified to explain to you all the most important aspects of stem cells so I will leave most of the instructioning to Wikiepdia.

From the Wikipedia Article on Stem Cells found HERE, I wanted to post a few of the main points about the unique cells.

Stem cellsarebiological cellsfound in all multicellularorganisms, that candivide(throughmitosis) anddifferentiateinto diverse specialized cell types and can self-renew to produce more stem cells. In mammals, there are two broad types of stem cells:embryonic stem cells, which are isolated from theinner cell massofblastocysts, andadult stem cells, which are found in various tissues. Inadultorganisms, stem cells andprogenitor cellsact as a repair system for the body, replenishing adult tissues. In a developing embryo, stem cells can differentiate into all the specialized cells (these are called pluripotent cells), but also maintain the normal turnover of regenerative organs, such as blood, skin, or intestinal tissues.

There are three accessible sources ofautologousadult stem cells in humans:

Stem cells can also be taken fromumbilical cord bloodjust after birth. Of all stem cell types, autologous harvesting involves the least risk. By definition, autologous cells are obtained from ones own body, just as one may bank his or her own blood for elective surgical procedures.

Highly plastic adult stem cells are routinely used in medical therapies, for example inbone marrow transplantation. Stem cells can now be artificially grown and transformed (differentiated) into specialized cell types with characteristics consistent with cells of various tissues such as muscles or nerves throughcell culture. Embryoniccell linesandautologousembryonic stem cells generated throughtherapeutic cloninghave also been proposed as promising candidates for futuretherapies.

The classical definition of a stem cell requires that it possess two properties:

Two mechanisms to ensure that a stem cell population is maintained exist:

Pluripotent, embryonic stem cells originate as inner cell mass (ICM) cells within a blastocyst. These stem cells can become any tissue in the body, excluding a placenta. Only cells from an earlier stage of the embryo, known as themorula, are totipotent, able to become all tissues in the body and the extraembryonic placenta.

Humanembryonicstem cellsA: Cell colonies that are not yet differentiated.B:Nervecell

Main article:Cell potency

Potencyspecifies the differentiation potential (the potential to differentiate into different cell types) of the stem cell.

The practical definition of a stem cell is the functional definitiona cell that has the potential to regenerate tissue over a lifetime. For example, the defining test for a bone marrow or hematopoietic stem cell (HSC) is the ability to transplant one cell and save an individual without HSCs. In this case, a stem cell must be able to produce new blood cells and immune cells over a long term, demonstrating potency. It should also be possible to isolate stem cells from the transplanted individual, which can themselves be transplanted into another individual without HSCs, demonstrating that the stem cell was able to self-renew.

Properties of stem cells can be illustratedin vitro, using methods such asclonogenic assays, in which single cells are assessed for their ability to differentiate and self-renew.Stem cells can also be isolated by their possession of a distinctive set of cell surface markers. However,in vitroculture conditions can alter the behavior of cells, making it unclear whether the cells will behave in a similar mannerin vivo. There is considerable debate as to whether some proposed adult cell populations are truly stem cells.

Embryonic stem (ES) cell lines are cultures of cells derived from theepiblasttissue of theinner cell mass(ICM) of ablastocystor earliermorulastage embryos.[9]A blastocyst is an early stageembryoapproximately four to five days old in humans and consisting of 50150 cells. ES cells arepluripotentand give rise during development to all derivatives of the three primarygerm layers: ectoderm, endoderm and mesoderm. In other words, they can develop into each of the more than 200 cell types of the adultbodywhen given sufficient and necessary stimulation for a specific cell type. They do not contribute to the extra-embryonic membranes or theplacenta. The endoderm is composed of the entire gut tube and the lungs, the ectoderm gives rise to the nervous system and skin, and the mesoderm gives rise to muscle, bone, bloodin essence, everything else that connects the endoderm to the ectoderm.

Stem cell division and differentiation. A: stem cell; B: progenitor cell; C: differentiated cell; 1: symmetric stem cell division; 2: asymmetric stem cell division; 3: progenitor division; 4: terminal differentiation

Also known assomatic(from Greek , of the body) stem cells and germline (giving rise to gametes) stem cells, they can be found in children, as well as adults.

Pluripotent adult stem cells are rare and generally small in number but can be found in a number of tissues including umbilical cord blood.A great deal of adult stem cell research to date has had the aim of characterizing the capacity of the cells to divide or self-renew indefinitely and their differentiation potential.In mice, pluripotent stem cells are directly generated from adult fibroblast cultures. Unfortunately, many mice do not live long with stem cell organs.

Most adult stem cells are lineage-restricted (multipotent) and are generally referred to by their tissue origin (mesenchymal stem cell, adipose-derived stem cell,endothelial stem cell,dental pulp stem cell, etc.).

Adult stem cell treatments have been successfully used for many years to treat leukemia and related bone/blood cancers through bone marrow transplants.

Multipotent stem cells are also found inamniotic fluid. These stem cells are very active, expand extensively without feeders and are not tumorigenic.Amniotic stem cellsare multipotent and can differentiate in cells of adipogenic, osteogenic, myogenic, endothelial, hepatic and also neuronal lines.[29]All over the world, universities and research institutes are studyingamniotic fluidto discover all the qualities of amniotic stem cells

These are not adult stem cells, but rather adult cells (e.g. epithelial cells) reprogrammed to give rise to pluripotent capabilities. Using genetic reprogramming with proteintranscription factors, pluripotent stem cells equivalent toembryonic stem cellshave been derived from human adult skin tissue

To ensure self-renewal, stem cells undergo two types of cell division (seeStem cell division and differentiationdiagram). Symmetric division gives rise to two identical daughter cells both endowed with stem cell properties. Asymmetric division, on the other hand, produces only one stem cell and aprogenitor cellwith limited self-renewal potential. Progenitors can go through several rounds of cell division before terminallydifferentiatinginto a mature cell. It is possible that the molecular distinction between symmetric and asymmetric divisions lies in differential segregation of cell membrane proteins (such asreceptors) between the daughter cells.

Stem cell treatmentsare a type of intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury. Manymedical researchersbelieve that stem cell treatments have the potential to change the face of human disease and alleviate suffering.The ability ofstem cellsto self-renew and give rise to subsequent generations with variable degrees of differentiation capacities,offers significant potential for generation of tissues that can potentially replace diseased and damaged areas in the body, with minimal risk of rejection and side effects

Me: I wanted to add for this last part that the list of pathologies that stem cell therapy can be used to treat for is really long and amazing. If you wanted to read up on all the types of things stem cells can be use to be treated for, click on the Wikipedia article on Stem Cell Treatments located HERE.

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Grow Taller Using Stem Cells , Part I - Natural Height Growth

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Stem Cell Therapy and Kidney Failure – ProgenCell

July 25th, 2018 5:43 pm

Stem Cell Therapy and Kidney Failure

Kidney failure (or renal failure) is a condition in which the kidneys fail to function properly. Physiologically, renal failure is described as a decrease in blood filtration (glomerular filtration rate or GFR). Clinically, this is manifested in elevated serum creatinine. Still not well understood are many of the factors that are involved in kidney failure. Researchers are studying the effects of nutritional proteins and the concentration of cholesterol in the blood.

Acute renal failure: Some kidney problems happen quickly, such as from an accident that causes kidney damage. A great loss of blood can cause sudden kidney failure, also some drugs or poisons can cause the kidneys to stop working. Such sudden drops in kidney function are called acute renal failure.

Are you living with Kidney Failure? Call us today for a FREE consultation for stem cell therapy or fill out the Case Evaluation Form to begin.

Stem cells are harvested from the patients own bone marrow, which includes fresh cells, proteins, growth factors and other tools necessary to rebuild damaged tissue. Although these substances exist naturally in an individuals bone marrow, they are usually not released into a persons bloodstream in sufficient quantities to repair damage throughout the body.

By liberating the stem cells and relocating them to an affected area, stem cell treatment solves this problem and provides relief to damaged tissue.

This regenerative effect makes stem cell therapy an attractive treatment option for patients suffering from degenerative illnesses, including auto-immune disorders, aging and damage from disease.

ProgenCells procedures are scientifically designed and professionally followed; we have one goal in mind: substantial health improvement using stem cell therapy for people with Kidney Failure.

We do not suggest that patients substitute their current medical doctor or abandon current treatments. Since this is a long-term protocol, it is necessary for your current medical doctor to continue to follow up on your case.

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Preventive Medicine – ACGME

July 25th, 2018 5:43 pm

The documents and resources housed within this section are provided by the Review Committee for Preventive Medicine and its staff at the ACGME to assistACGME-accredited programs and those applying for accreditation in this specialty and its subspecialties of clinical informatics, medical toxicology, and undersea and hyperbaric medicine.

Preventive medicine is the medical specialty that focuses on the promotion, protection, and maintenance of health and well-being, the prevention of disease and disability, and the premature death of individuals in defined populations.

Programs in preventive medicine focus on one of three areas:

Programs in aerospace medicine focus on the health of a population group consisting of the operational crews and passengers of air and space vehicles, and the support personnel required to operate such vehicles.

Programs in occupational medicine focus on the relationships among the health of workers; the arrangements of work; the physical, chemical, and social environments in the workplace; and the health outcomes of environmental exposures.

Programs in public health and general preventive medicine focus on health promotion and disease prevention in communities and other defined populations.

Directions on how to search for programs in one of the above areas of preventive medicine are available here.

PREVENTIVE MEDICINE SUBSPECIALTIES

Addiction MedicineClinical InformaticsMedical ToxicologyUndersea and Hyperbaric Medicine

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Gout – Wikipedia

July 25th, 2018 5:41 pm

GoutSynonymsPodagraThe Gout (James Gillray, 1799) depicts the pain of the artist's podagra as a demon or dragon.[1][2]SpecialtyRheumatologySymptomsJoint pain, swelling, and redness[3]Usual onsetOlder males[4]CausesUric acid[4]Risk factorsDiet high in meat or beer, overweight[4][5]Differential diagnosisJoint infection, reactive arthritis, pseudogout, others[6]PreventionWeight loss, vitamin C, not drinking alcohol, allopurinol[4]TreatmentNSAIDs, steroids, colchicine[7]Frequency1 to 2% (developed world)[4]

Gout is a form of inflammatory arthritis characterized by recurrent attacks of a red, tender, hot, and swollen joint.[3] Pain typically comes on rapidly in less than twelve hours.[4] The joint at the base of the big toe is affected in about half of cases.[8] It may also result in tophi, kidney stones, or urate nephropathy.[4]

Gout is due to persistently elevated levels of uric acid in the blood.[4] This occurs due to a combination of diet and genetic factors.[4] At high levels, uric acid crystallizes and the crystals deposit in joints, tendons, and surrounding tissues, resulting in an attack of gout.[4] Gout occurs more commonly in those who regularly eat meat or seafood, drink beer, or are overweight.[4][5] Diagnosis of gout may be confirmed by the presence of crystals in the joint fluid or in a deposit outside the joint.[4] Blood uric acid levels may be normal during an attack.[4]

Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, or colchicine improves symptoms.[4] Once the acute attack subsides, levels of uric acid can be lowered via lifestyle changes and in those with frequent attacks, allopurinol or probenecid provides long-term prevention.[4] Taking vitamin C and eating a diet high in low fat dairy products may be preventive.[9]

Gout affects about 1 to 2% of the Western population at some point in their lives.[4] It has become more common in recent decades.[4] This is believed to be due to increasing risk factors in the population, such as metabolic syndrome, longer life expectancy, and changes in diet.[4] Older males are most commonly affected.[4] Gout was historically known as "the disease of kings" or "rich man's disease".[4][10] It has been recognized at least since the time of the ancient Egyptians.[4]

Gout can present in multiple ways, although the most usual is a recurrent attack of acute inflammatory arthritis (a red, tender, hot, swollen joint).[3] The metatarsal-phalangeal joint at the base of the big toe is affected most often, accounting for half of cases.[8] Other joints, such as the heels, knees, wrists, and fingers, may also be affected.[8] Joint pain usually begins over 24hours and during the night.[8] This is mainly due to lower body temperature.[11] Other symptoms may rarely occur along with the joint pain, including fatigue and a high fever.[8][11]

Long-standing elevated uric acid levels (hyperuricemia) may result in other symptoms, including hard, painless deposits of uric acid crystals known as tophi. Extensive tophi may lead to chronic arthritis due to bone erosion.[12] Elevated levels of uric acid may also lead to crystals precipitating in the kidneys, resulting in stone formation and subsequent urate nephropathy.[13]

The crystallization of uric acid, often related to relatively high levels in the blood, is the underlying cause of gout. This can occur because of diet, genetic predisposition, or underexcretion of urate, the salts of uric acid.[3] Underexcretion of uric acid by the kidney is the primary cause of hyperuricemia in about 90% of cases, while overproduction is the cause in less than 10%.[4] About 10% of people with hyperuricemia develop gout at some point in their lifetimes.[14] The risk, however, varies depending on the degree of hyperuricemia. When levels are between 415 and 530mol/l (7 and 8.9mg/dl), the risk is 0.5% per year, while in those with a level greater than 535mol/l (9mg/dL), the risk is 4.5% per year.[11]

Dietary causes account for about 12% of gout,[3] and include a strong association with the consumption of alcohol, fructose-sweetened drinks, meat, and seafood.[12][15] Among foods richest in purines yielding high amounts of uric acid are dried anchovies, shrimp, organ meat, dried mushrooms, seaweed, and beer yeast.[16] Other triggers include physical trauma and surgery.[4]

Studies in the early 2000s found that other dietary factors are not relevant.[15][17] Specifically, moderate consumption of purine-rich vegetables (e.g., beans, peas, lentils, and spinach) are not associated with gout.[18] Neither is total consumption of protein.[17][18] Alcohol consumption is strongly associated with increased risk, with wine presenting somewhat less of a risk than beer or spirits.[18][19]

The consumption of coffee, vitamin C, and dairy products, as well as physical fitness, appear to decrease the risk.[20][21][22][23] This is believed to be partly due to their effect in reducing insulin resistance.[22]

Gout is partly genetic, contributing to about 60% of variability in uric acid level.[4] The SLC2A9, SLC22A12, and ABCG2 genes have been found to be commonly associated with gout and variations in them can approximately double the risk.[24][25] Loss-of-function mutations in SLC2A9 and SLC22A12 cause hereditary hypouricaemia by reducing urate absorption and unopposed urate secretion.[25] The rare genetic disorders familial juvenile hyperuricemic nephropathy, medullary cystic kidney disease, phosphoribosylpyrophosphate synthetase superactivity and hypoxanthine-guanine phosphoribosyltransferase deficiency as seen in Lesch-Nyhan syndrome, are complicated by gout.[4]

Gout frequently occurs in combination with other medical problems. Metabolic syndrome, a combination of abdominal obesity, hypertension, insulin resistance, and abnormal lipid levels, occurs in nearly 75% of cases.[8] Other conditions commonly complicated by gout include lead poisoning, kidney failure, hemolytic anemia, psoriasis, solid organ transplants and myeloproliferative disorders such as polycythemia.[4][26] A body mass index greater than or equal to 35 increases male risk of gout threefold.[15] Chronic lead exposure and lead-contaminated alcohol are risk factors for gout due to the harmful effect of lead on kidney function.[27] Lesch-Nyhan syndrome is often associated with gouty arthritis.

Diuretics have been associated with attacks of gout. However, a low dose of hydrochlorothiazide does not seem to increase risk.[28] Other medications that increase the risk include niacin, aspirin (acetylsalicylic acid), ACE inhibitors, angiotensin receptor blockers (except losartan), beta blockers, ritonavir, and pyrazinamide.[12][29] The immunosuppressive drugs ciclosporin and tacrolimus are also associated with gout,[4] the former more so when used in combination with hydrochlorothiazide.[30]

Gout is a disorder of purine metabolism,[4] and occurs when its final metabolite, uric acid, crystallizes in the form of monosodium urate, precipitating and forming deposits (tophi) in joints, on tendons, and in the surrounding tissues.[12] Microscopic tophi may be walled off by a ring of proteins, which blocks interaction of the crystals with cells and therefore avoids inflammation.[31] Naked crystals may break out of walled-off tophi due to minor physical damage to the joint, medical or surgical stress, or rapid changes in uric acid levels.[31] When they break through the tophi, they trigger a local immune-mediated inflammatory reaction in macrophages, which is initiated by the NLRP3 inflammasome protein complex.[12][29][31] Activation of the NLRP3 inflammasome recruits the enzyme caspase 1, which converts pro-interleukin 1 into active interleukin 1, one of the key proteins in the inflammatory cascade.[29] An evolutionary loss of urate oxidase (uricase), which breaks down uric acid, in humans and higher primates has made this condition common.[4]

The triggers for precipitation of uric acid are not well understood. While it may crystallize at normal levels, it is more likely to do so as levels increase.[12][32] Other triggers believed to be important in acute episodes of arthritis include cool temperatures, rapid changes in uric acid levels, acidosis,[33][34] articular hydration and extracellular matrix proteins, such as proteoglycans, collagens, and chondroitin sulfate.[4] The increased precipitation at low temperatures partly explains why the joints in the feet are most commonly affected.[3] Rapid changes in uric acid may occur due to factors including trauma, surgery, chemotherapy, diuretics, and stopping or starting allopurinol.[11] Calcium channel blockers and losartan are associated with a lower risk of gout compared to other medications for hypertension.[35]

Gout may be diagnosed and treated without further investigations in someone with hyperuricemia and the classic acute arthritis of the base of the great toe (known as podagra). Synovial fluid analysis should be done, however, if the diagnosis is in doubt.[11][36] X-rays, while useful for identifying chronic gout, have little utility in acute attacks.[4]

A definitive diagnosis of gout is based upon the identification of monosodium urate crystals in synovial fluid or a tophus.[8] All synovial fluid samples obtained from undiagnosed inflamed joints by arthrocentesis should be examined for these crystals.[4] Under polarized light microscopy, they have a needle-like morphology and strong negative birefringence. This test is difficult to perform and requires a trained observer.[37] The fluid must be examined relatively soon after aspiration, as temperature and pH affect solubility.[4]

Hyperuricemia is a classic feature of gout, but nearly half of the time gout occurs without hyperuricemia and most people with raised uric acid levels never develop gout.[8][38] Thus, the diagnostic utility of measuring uric acid levels is limited.[8] Hyperuricemia is defined as a plasma urate level greater than 420 mol/l (7.0mg/dl) in males and 360 mol/l (6.0mg/dl) in females.[39] Other blood tests commonly performed are white blood cell count, electrolytes, kidney function and erythrocyte sedimentation rate (ESR). However, both the white blood cells and ESR may be elevated due to gout in the absence of infection.[40][41] A white blood cell count as high as 40.0109/l (40,000/mm3) has been documented.[11]

The most important differential diagnosis in gout is septic arthritis.[4][8] This should be considered in those with signs of infection or those who do not improve with treatment.[8] To help with diagnosis, a synovial fluid Gram stain and culture may be performed.[8] Other conditions that can look similar include pseudogout, rheumatoid arthritis, psoriatic arthritis, and reactive arthritis.[8][29] Gouty tophi, in particular when not located in a joint, can be mistaken for basal cell carcinoma[42] or other neoplasms.[43]

Both lifestyle changes and medications can decrease uric acid levels. Dietary and lifestyle choices that are effective include reducing intake of purine-rich foods of animal origin such as meat and seafood, alcohol, and fructose (especially high fructose corn syrup).[5] Eating dairy products, vitamin C, coffee, and cherries may help prevent gout attacks, as does losing weight.[5][44] Gout may be secondary to sleep apnea via the release of purines from oxygen-starved cells. Treatment of apnea can lessen the occurrence of attacks.[45]

A number of medications are useful for preventing further episodes of gout, including allopurinol, febuxostat, and probenecid.[46] Long term medications are not recommended until a person has had two attacks of gout,[3] unless destructive joint changes, tophi, or urate nephropathy exist.[13] It is not until this point that medications are cost-effective.[3] They are not usually started until one to two weeks after an acute flare has resolved, due to theoretical concerns of worsening the attack.[3] They are often used in combination with either an NSAID or colchicine for the first three to six months.[4]

Urate-lowering measures should be increased until serum uric acid levels are below 300360mol/l (5.06.0mg/dl) and continue indefinitely.[3][4][47] If these medications are in chronic use at the time of an attack, it is recommended that they be continued.[8] Levels that cannot be brought below 6.0mg/dl while attacks continue indicates refractory gout.[48]

While historically it is not recommended to start allopurinol during an acute attack of gout, this practice appears okay.[49] Allopurinol blocks uric acid production, and is the most commonly used agent.[3] Long term therapy is safe and well tolerated, and can be used in people with renal impairment or urate stones, although hypersensitivity occurs in a small number of individuals.[3]

Febuxostat is typically only recommended in those who cannot tolerate allopurinol.[50] There are concerns about more heart related deaths with febuxostat compared to allopurinol.[51] Probenecid appears to be less effective than allopurinol and is a second line agent.[3][46] Probenecid may be used if undersecretion of uric acid is present (24-hour urine uric acid less than 800mg).[52] It is, however, not recommended if a person has a history of kidney stones.[52] Pegloticase is an option for the 3% of people who are intolerant to other medications.[53] It is a third line agent.[46] Pegloticase is administered as an intravenous infusion every two weeks,[53] and reduces uric acid levels.[54] Pegloticase is useful decreasing tophi but has a high rate of side effects and many people develop resistance to it.[55][46] In 2016 it was withdrawn from the European market.[56][57]

The initial aim of treatment is to settle the symptoms of an acute attack.[58] Repeated attacks can be prevented by medications that reduce serum uric acid levels.[58] Tentative evidence supports the application of ice for 20 to 30 minutes several times a day to decrease pain.[59] Options for acute treatment include nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, and steroids.[3] While steroids and NSAIDs work equally well, steroids may be safer.[60] Options for prevention include allopurinol, febuxostat, and probenecid. Lowering uric acid levels can cure the disease.[4] Treatment of associated health problems is also important.[4] Lifestyle interventions have been poorly studied.[59] It is unclear whether dietary supplements have an effect in people with gout.[61]

Nonsteroidal anti-inflammatory drug (NSAIDs) are the usual first-line treatment for gout. No specific agent is significantly more or less effective than any other.[3] Improvement may be seen within four hours and treatment is recommended for one to two weeks.[3][4] They are not recommended, however, in those with certain other health problems, such as gastrointestinal bleeding, kidney failure, or heart failure.[62] While indometacin has historically been the most commonly used NSAID, an alternative, such as ibuprofen, may be preferred due to its better side effect profile in the absence of superior effectiveness.[28] For those at risk of gastric side effects from NSAIDs, an additional proton pump inhibitor may be given.[63] There is some evidence that COX-2 inhibitors may work as well as nonselective NSAIDs for acute gout attack with fewer side effects.[64][65]

Colchicine is an alternative for those unable to tolerate NSAIDs.[3] At high doses, side effects (primarily gastrointestinal upset) limit its usage.[66] At lower doses, which are still effective, it is well tolerated.[28][67] Colchicine may interact with other commonly prescribed drugs, such as atorvastatin and erythromycin, among others.[66]

Glucocorticoids have been found to be as effective as NSAIDs[68][69] and may be used if contraindications exist for NSAIDs. They also lead to improvement when injected into the joint. A joint infection must be excluded, however, as steroids worsen this condition.[3]

Interleukin-1 inhibitors, such as canakinumab, showed moderate effectiveness for pain relief and reduction of joint swelling, but have increased risk of adverse events, such as back pain, headache, and increased blood pressure.[70] They, however, may work less well than usual doses of NSAIDS.[70] The high cost of this class of drugs may also discourage their use for treating gout.[70]

Without treatment, an acute attack of gout usually resolves in five to seven days; however, 60% of people have a second attack within one year.[11] Those with gout are at increased risk of hypertension, diabetes mellitus, metabolic syndrome, and kidney and cardiovascular disease and thus are at increased risk of death.[4][71] It is unclear whether medications that lower urate affect cardiovascular disease risks.[72] This may be partly due to its association with insulin resistance and obesity, but some of the increased risk appears to be independent.[71]

Without treatment, episodes of acute gout may develop into chronic gout with destruction of joint surfaces, joint deformity, and painless tophi.[4] These tophi occur in 30% of those who are untreated for five years, often in the helix of the ear, over the olecranon processes, or on the Achilles tendons.[4] With aggressive treatment, they may dissolve. Kidney stones also frequently complicate gout, affecting between 10 and 40% of people and occur due to low urine pH promoting the precipitation of uric acid.[4] Other forms of chronic kidney dysfunction may occur.[4]

Gouty tophi presenting as nodules on the finger and helix of the ear

Tophii on the toe and ankle

Gout complicated by ruptured tophi, the exudite of which tested positive for uric acid crystals

Gout in the joint of the big toe

Gout affects around 12% of the Western population at some point in their lifetimes and is becoming more common.[3][4] Some 5.8 million people were affected in 2013.[73] Rates of gout approximately doubled between 1990 and 2010.[12] This rise is believed to be due to increasing life expectancy, changes in diet and an increase in diseases associated with gout, such as metabolic syndrome and high blood pressure.[15] Factors that influence rates of gout, include age, race, and the season of the year. In men over 30 and women over 50, rates are 2%.[62]

In the United States, gout is twice as likely in males of African descent than those of European descent.[74] Rates are high among Pacific Islanders and the Mori, but the disease is rare in aboriginal Australians, despite a higher mean uric acid serum concentration in the latter group.[75] It has become common in China, Polynesia, and urban sub-Saharan Africa.[4] Some studies found that attacks of gout occur more frequently in the spring. This has been attributed to seasonal changes in diet, alcohol consumption, physical activity, and temperature.[76]

The term "gout" was initially used by Randolphus of Bocking, around 1200 AD. It is derived from the Latin word gutta, meaning "a drop" (of liquid).[77] According to the Oxford English Dictionary, this is derived from humorism and "the notion of the 'dropping' of a morbid material from the blood in and around the joints".[78]

Gout has been known since antiquity. Historically, it was referred to as "the king of diseases and the disease of kings"[4][79] or "rich man's disease".[10] The first documentation of the disease is from Egypt in 2,600 BC in a description of arthritis of the big toe. Greek physician Hippocrates around 400 BC commented on it in his Aphorisms, noting its absence in eunuchs and premenopausal women.[77][80] Aulus Cornelius Celsus (30 AD) described the linkage with alcohol, later onset in women and associated kidney problems:

Again thick urine, the sediment from which is white, indicates that pain and disease are to be apprehended in the region of joints or viscera... Joint troubles in the hands and feet are very frequent and persistent, such as occur in cases of podagra and cheiragra. These seldom attack eunuchs or boys before coition with a woman, or women except those in whom the menses have become suppressed... some have obtained lifelong security by refraining from wine, mead and venery.[81]

In 1683, Thomas Sydenham, an English physician, described its occurrence in the early hours of the morning and its predilection for older males:

Gouty patients are, generally, either old men or men who have so worn themselves out in youth as to have brought on a premature old ageof such dissolute habits none being more common than the premature and excessive indulgence in venery and the like exhausting passions. The victim goes to bed and sleeps in good health. About two o'clock in the morning he is awakened by a severe pain in the great toe; more rarely in the heel, ankle, or instep. The pain is like that of a dislocation and yet parts feel as if cold water were poured over them. Then follows chills and shivers and a little fever... The night is passed in torture, sleeplessness, turning the part affected and perpetual change of posture; the tossing about of body being as incessant as the pain of the tortured joint and being worse as the fit comes on.[82]

Dutch scientist Antonie van Leeuwenhoek first described the microscopic appearance of urate crystals in 1679.[77] In 1848, English physician Alfred Baring Garrod identified excess uric acid in the blood as the cause of gout.[83]

Gout is rare in most other animals due to their ability to produce uricase, which breaks down uric acid.[84] Humans and other great apes do not have this ability, thus gout is common.[11][84] Other animals with uricase include fish, amphibians, and most non primate mammals.[85] The Tyrannosaurus rex specimen known as "Sue", however, is believed to have suffered from gout.[86]

A number of new medications are under study for treating gout, including anakinra, canakinumab, and rilonacept.[87] Canakinumab may result in better outcomes than a low dose of a steroid, but costs five thousand times more.[88] A recombinant uricase enzyme (rasburicase) is available; its use, however, is limited, as it triggers an immune response. Less antigenic versions are in development.[11]

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FAQs – Ocean Springs, MS – Gulf Coast Stem Cell …

July 25th, 2018 5:41 pm

Our Technology

Gulf Coast Stem Cell & Regenerative Medicine Center (GCSC&RMC) uses adipose-derived stem cells for deployment & clinical research. Early stem cell research has traditionally been associated with the controversial use of embryonic stem cells. The new focus is on non-embryonic adult mesenchymal stem cells which are found in a persons own blood, bone marrow, and fat. Most stem cell therapy centers in the world are currently using stem cells derived from bone marrow.

A recent technological breakthrough enables us to now use adipose (fat) derived stem cells. Autologous stem cells from a persons own fat are easy to harvest safely under local anesthesia and are abundant in quantities up to 2500 times those seen in bone marrow.

Clinical success and favorable outcomes appear to be related directly to the quantity of stem cells deployed. Once these adipose-derived stem cells are administered back into the patient, they have the potential to repair human tissue by forming new cells of mesenchymal origin, such as cartilage, bone, ligaments, tendons, nerve, fat, muscle, blood vessels, and certain internal organs. Stem cells ability to form cartilage and bone makes them potentially highly effective therapy for degenerative orthopedic conditions. Their ability to form new blood vessels and smooth muscle makes them potentially very useful in treating Peyronies disease and impotence. Stem cells are used extensively in Europe and Asia to treat these conditions.

We have anecdotal and experimental evidence that stem cell therapy is effective in healing and regeneration. Stem cells seek out damaged tissues in order to repair the body naturally. The literature and internet are full of successful testimonials but we are still awaiting definitive studies demonstrating the efficacy of stem cell therapy. Such data may take five or ten years to accumulate. In an effort to provide relief for patients suffering from certain degenerative diseases that have been resistant to common modalities of medical care, we are initiating pilot studies as experimental tests of therapy effectiveness with very high numbers of adipose-derived stem cells obtained from fat. Adipose fat is an abundant and reliable source of stem cells.

GCSC&RMCs cell harvesting and isolation techniques are based on technology from Korea. This new technological breakthrough allows patients to safely receive their own autologous stem cells in extremely large quantities. Our therapy and research are patient funded and we have endeavored successfully to make it affordable. All of our sterile procedures are non-invasive and done under local anesthesia. Patients who are looking for non-surgical alternatives to their degenerative disorders can participate in our trials by filling out our application to determine if they are candidates.GCSC&RMC is proud to be state of the art in the new field of Regenerative Medicine. RETURN TO TOP

We are currently in the process of setting up FDA approved protocols for stem cell banking in collaboration with a reputable cryo-technology company. This enables a person to receive autologous stem cells at any time in the future without having to undergo liposuction which may be inconvenient or contraindicated. Having your own stem cells available for medical immediate use is a valuable medical asset.

Provisions are nearly in place for this option and storage of your own stem cells obtained by liposuction at GCSC&RMC or from fat obtained from cosmetic procedures performed elsewhere should be possible in the near future. RETURN TO TOP

Adult (NonEmbryonic) Mesenchymal Stem Cells are undifferentiated cells that have the ability to replace dying cells and regenerate damaged tissue. These special cells seek out areas of injury, disease, and destruction where they are capable of regenerating healthy cells and enabling a persons natural healing processes to be accelerated. As we gain a deeper understanding of their medical function and apply this knowledge, we are realizing their enormous therapeutic potential to help the body heal itself. Adult stem cells have been used for a variety of medicaltherapies to repair and regenerate acute and chronically damaged tissues in humans and animals. The use of stem cells is not FDA approved for treating any specific disease in the United States at this time and their use is therefore investigational. Many reputable international centers have been using stem cell therapy to treat various chronic degenerative conditions as diverse as severe neurologic diseases, renal failure, erectile dysfunction, degenerative orthopedic problems, and even cardiac and pulmonary diseases to name a few. Adult stem cells appear to be particularly effective at repairing cartilage in degenerated joints. RETURN TO TOP

Regenerative Medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to damage, or congenital defects. This field holds the promise of regenerating damaged tissues and organs in the body by stimulating previously irreparable organs to heal themselves. (Wikipedia) RETURN TO TOP

Traditionally, we have used various medications and hormones to limit disease and help the body repair itself. For example, hormone replacement therapy has, in many cases, shown the ability to more optimally help the immune system and thus help us repair diseased or injured tissues. Genetic research is an evolving area where we will eventually learn and utilize more ways of specifically dealing with gene defects causing degenerative disease. Stem cell therapy is another rapidly evolving and exciting area that has already shown considerable promise in treating many degenerative conditions. RETURN TO TOP

A stem cell is basically any cell that can replicate and differentiate. This means the cell can not only multiply, it can turn into different types of tissues. There are different kinds of stem cells. Most people are familiar with or have heard the term embryonic stem cell. These are cells from the embryonic stage that have yet to differentiate as such, they can change into any body part at all. These are then called pluripotential cells. Because they are taken from unborn or unwanted embryos, there has been considerable controversy surrounding their use. Also, while they have been used in some areas of medicine particularly, outside the United States they have also been associated with occasional tumor (teratoma) formations. There is work being conducted by several companies to isolate particular lines of embryonic stem cells for future use.

Another kind of stem cell is the adult stem cell. This is a stem cell that already resides in ones body within different tissues. In recent times, much work has been done isolating bone-marrow derived stem cells. These are also known as mesenchymal stem cells because they come from the mesodermal section of your body. They can differentiate into bone and cartilage, and probably all other mesodermal elements, such as fat, connective tissue, blood vessels, muscle and nerve tissue. Bone marrow stem cells can be extracted and because they are low in numbers, they are usually cultured in order to multiply their numbers for future use. As it turns out, fat is also loaded with mesenchymal stem cells. In fact, it has hundreds if not thousands of times more stem cells compared to bone marrow. Today, we actually have tools that allow us to separate the stem cells from fat. Because most people have adequate fat supplies and the numbers of stem cells are so great, there is no need to culture the cells over a period of days and they can be used right away. RETURN TO TOP

These adult stem cells are known as progenitor cells. This means they remain dormant (do nothing) unless they witness some level of tissue injury. Its the tissue injury that turns them on. So, when a person has a degenerative type problem, the stem cells tend to go to that area of need and stimulate the healing process. Were still not sure if they simply change into the type of injured tissue needed for repair or if they send out signals that induce the repair by some other mechanism. Suffice it to say that there are multiple animal models and a plethora of human evidence that indicates these are significant reparative cells. RETURN TO TOP

This will depend on the type of degenerative condition you have. A specialist will evaluate you and discuss whether youre a potential candidate for stem cell therapy. If after youve been recommended for therapy, had an opportunity to understand the potential risks and benefits, and decided on your own that you would like to explore this avenue, then you can be considered for stem cell therapy. Of course, even though its a minimally invasive procedure, you will still need to be medically cleared for the procedure. RETURN TO TOP

NO. However, GCSC&RMCs procedures fall under the category of physicians practice of medicine, wherein the physician and patient are free to consider their chosen course for medical care. The FDA does have guidelines about therapy and manipulation of a patients own tissues. At GCSC&RMC we meet these guidelines by providing same day deployment with the patients own cells that undergo very minimal manipulation and are inserted during the same procedure. RETURN TO TOP

No. Only adult mesenchymal stem cells are used. These cells are capable of forming bone, cartilage, fat, muscle, ligaments, blood vessels, and certain organs. Embryonic stem cells are associated with ethical considerations and limitations. RETURN TO TOP

Patients suffer from many varieties of degenerative illnesses. There may be conditions associated with nearly all aspects of the body. Board-certified specialists are ideal to evaluate, recommend and/or treat, and subsequently, follow your progress. Together, through the GCSC&RMC, we work to coordinate and provide therapy mainly with your own stem cells, but also through other avenues of regenerative medicine. This could include hormone replacement therapy or other appropriate recommendations.

For example, if you have a knee problem, you would see GCSC&RMCs Board Certified orthopedic surgeon rather than a generic clinic director. Also, you might be recommended for evaluation for hormone replacement therapy or an exercise program should such be considered optimal. Nonetheless, we believe stem cell therapy to be the likely foundation for regenerative medicine.It should also be noted, that all therapies are currently in the investigational stage. While we recognize our patients are seeking improvement in their condition through stem cell therapy, each deployment is part of an ongoing investigation to establish optimal parameters for future therapies, to evaluate for effectiveness and for any adverse effects. It is essential that patients understand they are participating in these investigational (research) analyses. Once sufficient information is appropriately documented and statistically significant, then data (validated by an Institutional Review Board) may be presented to the FDA for consideration of making an actual claim. RETURN TO TOP

Urology, cosmetic surgery, ear, nose, & throat, orthopedics, internal medicine, and cardiology are represented. Plans are currently being made for a number of other specialties. GCSC&RMC is the first multi-specialty stem cell center in the United States. RETURN TO TOP

Many have been told that they require surgery or other risky procedures for their ailments and are looking for non-invasive options. Some have heard about the compelling testimonials about stem cells in the literature and on various websites. Many have read about the results of stem cell therapy in animal models and in humans. GCSC&RMC gives a choice to those informed patients who seek modern regenerative therapy but desire convenience, quality, and affordability. GCSC&RMC fills a need for those patients who have been told that they have to travel to different countries and pay as much as twenty to one hundred thousand dollars for stem cell therapy offshore. (See stem cell tourism). RETURN TO TOP

Stem cells are harvested and deployed during the same procedure. Our patients undergo a minimally-invasive liposuction type of harvesting procedure by a qualified surgeon in our facility in Ocean Springs, Mississippi. The harvesting procedure generally lasts a few minutes and can be done under local anesthesia. Cells are then processed and are ready for deployment within 90 minutes or less. RETURN TO TOP

Bone marrow sampling (a somewhat uncomfortable procedure) yields approximately 5,000 60,000 cells that are then cultured over several days to perhaps a few million cells prior to deployment (injection into the patient). Recent advances in stem cell science have made it possible to obtain high numbers of very excellent quality multi-potent (able to form numerous other tissues) cells from a persons own liposuction fat. GCSC&RMC uses technology acquired from Asia to process this fat to yield approximately five hundred thousand to one million stem cells per cc of fat, and therefore, it is possible to obtain as many as 10 to 40 million cells from a single procedure. These adipose-derived stem cells can form many different types of cells when deployed properly including bone, cartilage, tendon (connective tissue), muscle, blood vessels, nerve tissue and others. RETURN TO TOP

GCSC&RMC patients have their fat (usually abdominal) harvested in our special sterile facility under a local anesthetic. The fat removal procedure lasts approximately twenty minutes. Specially designed equipment is used to harvest the fat cells and less than 100cc of fat is required. Postoperative discomfort is minimal and there is minimal restriction on activity. RETURN TO TOP

Stem cells are harvested under sterile conditions using a special closed system technology so that the cells never come into contact with the environment throughout the entire process from removal to deployment. Sterile technique and antibiotics are also used to prevent infection. RETURN TO TOP

No. Only a persons own adult autologous cells are used. These are harvested from each individual and deployed back into their own body. There is no risk of contamination or risk of introduction of mammalian DNA. RETURN TO TOP

These facilities are obtaining stem cells from bone marrow or blood in relatively small quantities and they are then culturing (growing) the cells to create adequate quantities. Research seems to indicate that success of stem cell therapy is directly related to the quantity of cells injected. GCSC&RMC uses adipose derived stem cells that are abundant naturally at approximately 2,500 times levels found in bone marrow (the most common source of mesenchymal stem cells). GCSC&RMC uses technology that isolates adipose stem cells in vast numbers in a short time span so that prolonged culturing is unnecessary and cells can be deployed into a patient within 90 minutes of harvesting. RETURN TO TOP

GCSC&RMC is doing pioneer research for treating many diseases. All investigational data is being collected so that results will be published in peer review literature and ultimately used to promote the advancement of cellular based regenerative medicine. FDA regulations mandate that no advertising medical claims be made and that even website testimonials are prohibited. RETURN TO TOP

No. Many are confused by this because they have heard of cancer patients receiving stem cell transplants. These patients had ablative bone marrow therapy and need stem cells to re-populate their blood and marrow. This is different from the stem cells we deploy to treat noncancerous human diseases at GCSC&RMC. RETURN TO TOP

Adult mesenchymal stem cells are not known to cause cancer. Some patients have heard of stories of cancer caused by stem cells, but these are probably related to the use of embryonic cells (Not Adult Mesenchymal Cells). These embryonic tumors known as teratomas are rare but possible occurrences when embryonic cells are used. RETURN TO TOP

Stem cell therapy is thought to be safe and not affect dormant cancers. If someone has had cancer that was treated and responded sucessfully, there is know reason to withhold stem cell deployment. In most cases, stem cells should not be used in patients with known active cancer. RETURN TO TOP

We know of no documented cases personally or in the literature where serious harm has resulted. All of our patients will be entered into a database to follow and report any adverse reactions. This information is vital to the development of stem cell science. There have been a few reports of serious complications from overseas and these are being thoroughly evaluated by epidemiologists to ascertain the facts. The International Stem Cell Society registry has over 1,000 cases currently registered and only 2% were associated with any complications, none of which were considered serious adverse events. RETURN TO TOP

None. Our aim is to make cell based medicine available to patients who are interested and to provide ongoing research data under approved Institutional Review Board (IRB) validated studies. We will follow our stem cell therapy patients over their lifetimes. This will enable us to accumulate significant data about the various degenerative diseases we treat. Instead of providing simply anecdotal or testimonial information, our goal is to categorize the various conditions and follow the patients progress through various objective (e.g. x-ray evidence or video displays) and subjective (e.g. patient and/or doctor surveys) criteria. We are aware of a lot of stories about marked improvement of a variety of conditions, but we make no claims about the intended therapy. At some point, once adequate amounts of data are accumulated, it might be appropriate to submit the information to the FDA at which point an actual claim may be substantiated and recognized by the Agency. Still, these are your own cells and not medicines for sale. They are only being used in your own body. Most likely, no claim needs to be made; rather a statistical analysis of our findings would suffice to suggest whether therapy is truly and significantly effective. We also hope to submit our patients data to an approved International Registry (See ICMS Stem Cell Registry) further fostering large collections of data to help identify both positive and negative trends. RETURN TO TOP

Our adipose derived stem cell harvesting and isolation technique yields extremely high numbers of stem cells. In reviewing outcomes data, therapy cell numbers appear to correlate with therapy success. Our cells are actually in a type of soup called Stromal Vascular Fraction SVF which is stem cells bathed in a rich mixture of natural growth factors (Not the same as human growth factor hormone which is only one type of growth factor). Some types of orthopedic and urologic diseases appear to respond better to stem cells that are super enriched with growth factors created by administering Platelet Rich Plasma to the patient. Autologous Platelet Rich Plasma is derived from a patients own blood drawn at the time of deployment. At GCSC&RMC we do not add any foreign substances or medications to the stem cells. RETURN TO TOP

Depending on the type of therapy required, stem cells can be injected through veins, arteries, into spinal fluid, subcutaneously, or directly into joints or organs. All of these are considered minimally invasive methods of introducing the stem cells. Stem cells injected intravenously are known to seek out and find (see photo) areas of tissue damage and migrate to that location thus potentially providing regenerative healing. Intravenously injected stem cells have been shown to have the capability of crossing the blood-brain barrier to enter the central nervous system and they can be identified in the patients body many months after deployment. Note yellow arrow showing the stem cells concentrated in the patients hand where he had a Dupytrens contracture (Dupuytrens contracture is a hand deformity that causes the tissue beneath the surface of the hand to thicken and contract). RETURN TO TOP

Different conditions are treated in different ways and there are different degrees of success. If the goal is regeneration of joint cartilage, one may not see expected results until several months. Some patients may not experience significant improvement and others may see dramatic regeneration of damaged tissue or resolution of disease. Many of the disorders and problems that the physicians at GCSC&RMC are treating represent pioneering work and there is a lack of data. FDA regulations prevent GCSC&RMC from making any claims about expectations for success, however, if you are chosen for therapy, it will be explained that we believe stem cell therapy may be beneficial or in some cases that we are unsure and therapy would be considered investigational. RETURN TO TOP

Stem cell therapy relies on the bodys own regenerative healing to occur. The regenerative process may take time, particularly with orthopedic patients, who may not see results for several months. In some diseases, more immediate responses are possible. RETURN TO TOP

No. Only certain medical problems are currently being treated at GCSC&RMC. Check our list or fill out a candidate application form on the website. All patients need to be medically stable enough to have the stem cell deployment in our facility. There may be some exceptional conditions that may eventually be treated in hospitalized patients, but that remains for the future. Some patients may be declined due to the severity of their problem. Other patients may not have conditions appropriate to treat or may not be covered by our specialists or our protocols. A waiting list or outside referral (if we know of someone else treating such a problem) might be applicable in such cases. RETURN TO TOP

Yes. Patients with uncontrolled cancer are excluded. If you have an active infection anywhere in your body you must be treated first. Severely ill patients may require special consideration. Also, anyone with a bleeding disorder or who takes blood thinning medications requires special evaluation before consideration for stem cells. RETURN TO TOP

The specialist seeing you at GCSC&RMC will make a determination based on your history and exam, studies, and current research findings. Any complex cases may be reviewed by our ethics advisory committee. Occasionally, we may seek opinions from thought leaders around the world. RETURN TO TOP

No. Participation in any of our protocols is not mandatory and there are no incentives, financial or otherwise, to induce patients to enroll in our studies. However, GCSC&RMC is dedicated to clinical research for the development of stem cell science. GCSC&RMC is taking an active role in cutting edge clinical research in the new field of regenerative medicine. Research studies will be explained and privacy will be maintained. Formal future research studies will be regulated by an Institutional Review Board which is an authorized agency that promotes validity, transparency and protection of human study enrollees. RETURN TO TOP

At this time, we are not treating autism, spinal cord injuries, and some advanced diseases. See list of problems currently being studied at GCSC&RMC. RETURN TO TOP

Patients who are considered to be candidates based on information provided in the candidate application form will be invited for a consultation with one of our panel physicians. $250 is charged for this consultation which includes office evaluation (but may also include physicians evaluation of X-Rays, records, or telephonic consultations). Unfortunately, insurance generally will not cover the actual cost of stem cell therapy in most cases since stem cell therapy is still considered experimental. The cost varies depending on the disease state being treated and which type of stem cell deployment is required. RETURN TO TOP

Because of recent innovations in technology, GCSC&RMC is able to provide outpatient stem cell therapy at a fraction of the cost of that seen in many overseas clinics. The fee covers fat cell harvesting, cell preparation, and stem cell deployment which may include the use of advanced interventional radiology and fluoroscopy techniques. Financing is available through a credit vendor. RETURN TO TOP

Stem cells can be cryopreserved in the form of liposuction fat for prolonged periods of time. Currently, this service is outsourced to an outside provider known to have excellent quality control. Many patients have been inquiring about banking cells while they are still young since stem cell numbers drop naturally with each decade of life and some advocate obtaining and saving cells to be used later in life as needed. (see chart). RETURN TO TOP

Most patients, especially those with orthopedic conditions, require only one deployment. Certain types of degenerative conditions, particularly auto-immune disease, may respond best to a series of stem cell deployments. The number and necessity of any additional procedures would be decided on a case by case basis. Financial consideration is given in these instances. RETURN TO TOP

A good resource is the International Cellular Medicine Society (ICMS). Stem Cells 101

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FAQs - Ocean Springs, MS - Gulf Coast Stem Cell ...

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Welcome to Integrated Health Concepts Bristol Clinic

July 24th, 2018 5:46 pm

Our Mission is to bring compassionate, individualized care to peopleto help empower individuals toward better health by helping them see the relationship between spiritual balance, emotional balance, and true well-being.

We are located at 28 Midway Street, Bristol, Tennessee, across the street from Kroger, and next door to Bristol Regional Counseling Center (see map)

For information or to make an appointment, telephone 423-573-9873.

Our hours are 8:00 am to 4:30 pm Monday thru Thursday.

The lack of all three resources results in a mud and stick hut. This is still better than nothing but there is lack in security and dependability. We could go through other scenarios but this should help you get the idea. Now, healing your being, not just your body, results in an abundance of love, joy, peace, and all divine things.

In order to heal there is an essential package, the foundation if you wish. Please watch this video as Dr. Schrenker explains about these four aspects of healing and well-being:

Please note: seeing your doctor for regular check-ups does not make this list, and certainly, pharmaceuticals are not included either.

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Welcome to Integrated Health Concepts Bristol Clinic

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Nutritional Counseling in Bristol, TN

July 24th, 2018 5:46 pm

It's often overlooked, but food plays a major role in your health and wellness. Making the correct choices on what to eat can improve your overall physical and mental fitness, and can even help mitigate certain illnesses. If you'd like help with nutrition, please call (423) 301-6964 or contact Dr. Joseph Radawi online.

During nutritional counseling, you'll work with a registered dietitian or nutritional counselor to develop a meal plan that fits your lifestyle. This includes selecting which foods to eat, along with monitoring habits and choices.

Nearly everyone can benefit from eating healthier. It is tough to improve your diet alone, so working with a dietitian can alleviate the burden.

Nutritional counseling can help you lose weight, which can aid with:

Diet counseling isn't just for people who struggle with their weight. If you're dealing with an illness, nutritional counseling may aid your recovery or help relieve symptoms.

Among many other conditions, nutritional counseling benefits those suffering from:

Counseling can also help you recuperate after chemotherapy or surgery. If you're struggling with yourweight or fighting illness, please call (423) 301-6964 or contact Dr. Joseph Radawi online.

When meeting with a medical professional, it's important to provide them with detailed information about your current diet and ailments. This may allow your diet expert to formulate the best possible plan to fit your needs, lifestyle, and budget.

Your dietitian will also recommend regular exercise, which is a key component to any nutritional counseling session. Like your food selection, your style and amount of exercise will be personalized to suit your needs.

Every diet is different, but a nutrition plan will typically be built around well-rounded foods including:

Many of these contain helpful Omega-3 fatty acids, which can improve everything from heart health to weight loss. A typical plan may also contain foods rich in vitamins and calcium, which can greatly aid bone strength.

A medical professional will help you set reasonable goals, so you can take your nutritional plan step by step.

Virtually everyone could benefit from diet guidance. Working with a medical professional to develop a custom plan can provide a bounty of benefits to your mental and physical well-being. To take the path toward a happier, healthier life please call (423) 301-6964 or contact Dr. Joseph Radawi online.

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Nutritional Counseling in Bristol, TN

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Iodine Deficiency Treatment in Bristol, TN

July 24th, 2018 5:46 pm

Iodine is an essential trace element found in very small amounts within the human body. Even though it doesn't take a lot of iodine to keep your body functioning normally, it can be hard for some people to get enough. According to Medscape, 29% of people in 130 countries around the world live in an iodine deficient area.

Fortunately, iodine deficiency treatment is available. To meet with a healthcare provider in Bristolwho can help restore your iodine levels, call (423) 301-6964 or contact Tri-Cities Functional Medicine online.

Iodine enters your body through the food you eat. Your body can't make it on its own. There tends to be less of it in soil, so people who only eat local foods without any supplementation may become deficient in iodine.

In the United States, most of us consume iodized salt or foods made with iodized salt. This means iodine has been added and helps our bodies meet its daily requirements.

Iodine's role in the body is to help make thyroid hormones. The thyroid is a butterfly-shaped gland found on the front of the neck behind the Adam's apple area. This gland is called a master gland because it sends out hormones that regulate many important functions of the body including metabolism, heart rate, body temperature and reproduction.

It's influence is extensive and when there is an imbalance in your iodine levels, your body may respond by making too much, or too little thyroid hormone for your body. A goiter, or swelling of the thyroid gland is a common occurrence with iodine deficiency. The thyroid is working so hard to make enough hormones that it enlarges and may show up as a knot on the front of the neck.

Iodine deficiency may be linked to a variety of other conditions as well. These include:

In most traditional medical practices, an imbalance in thyroid function will be treated with synthetic thyroid hormone if you aren't making enough, or your provider may recommendradiationor other treatments to kill off or stop part of your thyroid if you are making too much. These approaches only treat the symptoms.

Functional medicine looks beyond the symptoms and works to treat the root cause of the disease. Functional medicine treatment approach may include:

Your functional medicine provider is unlikely to prescribe a traditional medication for your iodine deficiency. He or she will do extensive testing to look for biologic, genetic and environmental factors that are influencing your health, and help you change those so you can fix the root cause and feel better.

Learn more about functional medicine and iodine deficiency. Call (423) 301-6964 or contact Tri-Cities Functional Medicine online today.

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Iodine Deficiency Treatment in Bristol, TN

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Regenerative Medicine – directorthocare.com

July 23rd, 2018 7:43 pm

Regenerative medicine is a game-changer in the world of medicine. Treatments include: Stem Cell Therapy, PRP (Platelet Rich Plasma) Therapy and Amniotic Stem Cell Therapy (Amnion). Each custom treatment option may help to heal damaged tissues and organs, offering solutions and hope for people whose conditions have proven beyond repair previously.

I didnt know anything about PRP when I went to my appointment with Dr. Hall. I was able to do some research before I had anything done. The stem cells come from my own bone marrow. Stem cell treatment is fairly new, but shows positive results. I decided that it was something that could help me. I trust Dr. Hall. Dr. Hall removed the stem cells from my hip and injected them into my knees while I was in surgery under anesthesia.

I was in physical therapy after the surgery. Now Im back in the gym three days a week, exercising on the elliptical machine, weight training and in yoga classes. I walk five miles four or five days a week.

In six weeks, I was at 133 degrees range of motion, which was only 4 degrees behind my good leg. I attribute my advanced recovery to the outstanding hands of the DOC surgeon, the PRP/stem cell therapy, and Mike at ATI Physical Therapy.I attribute my advanced recovery to the outstanding hands of the DOC surgeon, the PRP/stem cell therapy, and Mike at ATI Physical Therapy.

If you are reading this testimonial and questioning whether the extra money spent on the PRP and stem cell therapy are worth it, I would highly recommend that you take out a loan if necessary in order to benefit from this healing therapy.

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Ophthalmologists near Altoona, PA – Eye Surgeon

July 23rd, 2018 7:41 pm

Dr. Gordon's Biography Dr. Alan D. Gordon has practiced in Lewistown for over thirty years. He grew up in New Jersey and went to a small liberal arts college in Maine, Nasson College, during that time, Dr. Gordon did a study abroad program in Vienna, Austria during which time, he took courses in the history of medicine at the University of Vienna, Austria. His medical education began at the University of Bologna, Italy, the oldest medical school in the western world, and he graduated from the University of Medicine and Dentistry of New Jersey at Newark New Jersey (now Rutgers Medical School). Dr. Gordon followed Medical School with a medical internship at Martland Hospital, the main teaching hospital of the New Jersey College of Medicine. Dr. Gordon later completed his Ophthalmic Residency at the Guthrie Clinic in Sayre, PA. During his training, Dr. Gordon worked as a staff physician in several Emergency Rooms and while waiting for his Ophthalmology training, he worked for a year as a staff ER physician at the Samaritan Hospital in Troy, New York. He believes in medicine as a calling, and has done charity cataract and eye muscle surgery in Honduras and Ecuador for needy patients in association with Medical Ministry International. During his training at the Guthrie Clinic, he rotated through the Wills Eye Hospital in Philadelphia and attended the centralized training for ophthalmic residents at Colby College, Maine. He has regularly attended multiple continuing education courses including those held at the American Academy of Ophthalmology, the European Society of Cataract and Refractive Surgery and the American Society of Cataract and Refractive Surgery throughout his career. He is board certified for general ophthalmology by the American Board of Ophthalmology and has taken voluntary certification as a cataract sub specialist by the American Board of Eye Surgery. This certification involves direct observation of Dr. Gordon’s surgical procedures as well as a study involving surgical outcome. Dr. Gordon was certified by the American Board of Eye Surgery in 1992 and, because this certification is only granted for 10 years, he has been rectified. He is subspecialty certified for cataract surgery and has taught modern cataract/lens surgery to many ophthalmologists both in courses and individually. He is a member of the Outpatient Ophthalmic Surgery Society, the American Society of Cataract and Refractive Surgery, the American Association of Ambulatory Surgery Centers, the European Society of Cataract and Refractive Surgery, the American Board of Eye Surgery, the Pennsylvania Medical Society, several other medical societies, and he is a fellow of the American Academy of Ophthalmology. Last year, he was inducted into the American College of Surgeons as a fellow. Recently (2008), he was featured in an article in the Highmark Blue Shield magazine “Clinical Views”, after having been chosen by his peers as communicating with family physicians and internists to coordinate care. He lives with his wife in the Lewistown area.

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Ophthalmologists near Altoona, PA - Eye Surgeon

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About NSI Stem Cell | Natural Stem Cell Therapy Therapy …

July 23rd, 2018 12:45 am

Using the latest regenerative medicine technology, at NSI Stem Cell, its our mission to improve the quality and quantity of the lives of our patients while avoiding invasive surgical techniques and harmful medications.

If your house is on fire, you call the fire department. However, you dont call the fire department to come and rebuild the damaged areas of your house. The same is true when living with chronic illness and injury. For crisis situations, different types of medication may be necessary, but medicine alone will not truly fix the problem. Instead, depending on your condition, its important to incorporate a variety of remedies including: diet, exercise, physical therapy and in some cases stem cell therapy.

Using the latest regenerative medicine technology, at NSI Stem Cell, its our mission to improve the quality and quantity of the lives of our patients while avoiding invasive surgical techniques and harmful medications.

We are home to doctors and clinicians that are seasoned, knowledgeable, and passionate about helping patients. We work hard to provide seamless, safe and effective care for each patient that walks through our doors with the most advanced technology available to reverse disease, repair tissue, and promote health.

Learn more about what NSI Stem Cell can do for you below.

We know you have many choices when it comes to stem cell centers, so why choose NSI Stem Cell? First, we provide extensive patient education. The honesty and education that we give empower our patients to make informed decisions that will benefit them and their health the most.

Chances are, youve seen numerous doctors and from that, have had no real success in alleviating pain and restoring function. At NSI Stem Cell, we know the importance of finding someone that not only understands your medical journey, but provides the very best individualized care possible.

During your first visit to NSI Stem Cell, our doctors will provide a physical exam as well as go over the patients in-depth medical history. Additionally, the patients desires and expected outcomes can be discussed at length. Our medical team will spend as much time as necessary with each patient in order to ensure a proper diagnosis as well as educate the patient thoroughly on their condition as well as their available options.

NSI Stem Cell Services Include:

Stem Cell TherapyPlatelet Rich Plasma (PRP) Blood Injection TherapyFunctional RehabilitationNutritional Counseling

Because our consultations are done on an individual level, we are able to create precise programs such as a combination of the services listed above to help you regain function and return to everyday activities.

What I like about the [NSI Stem Cell] office is the professionalism, the care, the support, the answers to my questions and the continuing help whenever I need it. Leah

Over the last four years I have been suffering from pain, burning, numbness to the point where I couldnt get out of bed, couldnt function, couldnt work. Through all the many doctors that I visited over the years they gave me all kinds of medications where I had terrible reactions from them, ended up in the hospital and I couldnt function anymore. When I finally came to NSI, they gave me a program, and I felt wonderful. All my pain, all my numbness has disappeared. Im off all kinds of medications, Ive lost a lot of weight and I feel absolutely wonderful. Ths staff is awesome, the doctor is awesome, Im just so thankful that I found them. Connie

Click here to listen to additional stem cell success stories and testimonials

How are stem cells used? Stem cells make it possible for the body to regenerate and heal itself after an injury or illness. When stem cells are harvested from the patient and injected back in, they heal damaged tissues and regenerate new healthy tissue. Better yet, because stem cells use your body to heal itself, they contain the building blocks for optimal health.

Stem cells are important because they are changing how patients heal from chronic illness and/or injury. Stem cells are also multi-potent meaning they have the ability to differentiate into muscle tendons, ligaments, bone, tissue and cartilage. They are key in helping a wound heal and/or repairing damage brought on by disease. Furthermore, unlike invasive surgeries, stem cell therapy has no recovery time.

The first successful cell transplantation happened in 1956, as Dr. E. Donnall Thomas performed the first successful bone marrow transplant between identical twins, where a healthy twin gave their bone marrow to the other twin who suffered from leukemia. The practice continued to evolve over the decades and in 2006, it was discovered that stem cells can be harvested from adult patients.

Stem cells are a naturally occurring cell type that can be found all throughout the human body. Adult stem cells are found in the bone marrow, but they are also abundantly stored in the fatty layer that lies just beneath the skin. In addition, stores of stem cells remain in the body throughout life. Bone marrow and adipose (fat) are the two most commonly used stem cells in stem cell therapy.

Have more questions? Contact us today to see how stem cell therapy can help your condition.

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Stem Cell Treatment & Therapy for COPD | Pulmonary Disease

July 23rd, 2018 12:45 am

Overview

Chronic obstructive pulmonary disease (COPD) is a progressive, degenerative lung disease resulting from a long-term inflammatory response to inhaled irritants. As the inflammatory process continues, the small airways narrow, inhibiting airflow; and healthy lung tissue is broken down, preventing appropriate absorption of oxygen. Due to these disease processes, the ability to breathe becomes increasingly difficult. Eventually, even simple tasks and short bursts of activity can heavily strain an individuals stamina. The result is a substantially reduced quality of life for an individual with COPD.

There are 2 main types of COPD:

Emphysema

is a common type of COPD in which the air sacs of the lungs become damaged, causing them to enlarge and burst. Damage in this area makes it difficult for people with emphysema to expel air from their lungs.

Chronic Bronchitis

causes inflammation and irritation of the airways, the tubes in your lungs where air passes through. When the air tubes are inflamed and irritated, thick mucus begins to form in them. Over time, this mucus plugs up airways and makes breathing difficult.

Although there is no cure for the disease, many patients can experience a significant reduction in the severity of their symptoms through stem cell therapy for COPD. With a stem cell transplant for COPD to targeted areas in the lungs and airway, the progression of the disease can be slowed and the patients quality of life can be improved by the lessening of the diseases symptoms and complications. By focusing treatment on the specific areas of the respiratory system that are affected by the disease, stem cell therapy has the potential to make life easier for patients who have COPD. TruStem Cell Therapy has the potential to relieve multiple complications related to COPD, such as reduced stamina, decreased mobility, shortness of breath and respiratory infections.

Symptoms/Complications

Increased breathlessness

Frequent coughing (with and without sputum)

Wheezing

Tightness in chest

Reliance on supplementary oxygen

Causes

Smoking

About 85 to 90 percent of all COPD cases are caused by cigarette smoking. When a cigarette burns, it creates more than 7,000 chemicals, many of which are harmful. The toxins in cigarette smoke weaken your lungs defense against infections, narrow air passages, cause swelling in air tubes and destroy air sacsall contributing factors for COPD.

Environment

What you breathe every day at work, home and outside can play a role in developing COPD. Long-term exposure to air pollution, secondhand smoke and dust, fumes and chemicals (which are often work-related) can cause COPD.

Genetic

A small number of people have a rare form of COPD called alpha-1 deficiency-related emphysema. This form of COPD is caused by a genetic (inherited) condition that affects the bodys ability to produce a protein (Alpha-1) that protects the lungs.

TruStem Cell Therapy

TruStem Cell Therapy provides access to treatment that utilizes a patients stem cells isolated from his or her own fat tissue. There are multiple inherent benefits afforded by the utilization of adipose derived stem cells including their ability to differentiate into a broad variety of cell types (neurons, bone, cartilage, muscle, tendon, etc.), they are present at comparatively much higher levels than other stem cell types, possess higher immunomodulatory capacity, and they do not endanger a patients health the way other stem cells might.

Approximately 150-250ccs of a patients own fat tissue is harvested through a minimally invasive, mini liposuction procedure. Generally, this fat tissue is collected from around the patients belly region.

Adipose tissue is preferentially utilized because it is one of the richest, most accessible sources of stem cells in the human body.

Harvested fat tissue is immediately taken to the onsite laboratory for processing. At this step, an optimized protocol is used to isolate the maximum number of stem cells from collected fat tissue.

Stem cell activation is part of what makes TruStem Cell Therapy unique. The activation procedure is designed to augment efficacy.

TruStem Cell Therapy utilizes both systematic and novel administration methods to fully saturate the body with stem cells while targeting specific areas of injury.

COPD patients who receive stem cell therapy through us can receive multiple systemic and targeted administration methods:

Systemic IV infusion of their stem cells to fully saturate the entire body.

Stem cells are delivered via a nebulizer for distribution throughout and deep into the lungs as the patients breathe in the stem cells.

Our focus is safety, efficacy, and patient-centric care when providing access to superior stem cell therapy.

We utilize only board-certified surgeons, physicians and accredited clinicians to provide care for patients.

Laboratory protocols are developed and refined by our PhD Neuroscientist.

A clinical team with expertise in practicing cellular based medicine.

Accredited Surgical Centers for enhanced procedural and patient safety

Skilled Patient Advocates who are trained to provide truthful, realistic expectations resulting from stem cell therapy. We do not make outlandish promises of cures or inaccurate claims related to improvement rates.

FAQ

It is important for patients and caregivers to understand that current therapies, including stem cell treatment, do not provide a cure for COPD. However, TruStem Cell Therapy does have the potential to improve a patients quality of life by reducing symptoms and complications related to COPD as well as slowing its progression.

The FDA has not approved stem cell therapy for COPD. As noted above, studies have demonstrated the safety and efficacy of stem cell therapy for this condition but additional studies are needed before FDA approval can be secured.

It is possible through these treatments, to improve a patients quality of lifebyminimizing disease-relatedsymptoms and complications. For COPD patients, it is possible to see improvements in any one ormultipledisease-related complications such as: supplemental oxygen consumption, stamina, mobility, fatigue, respiratory infections, shortness of breath, etc. If you have questions regarding how these treatments may help you, please contact one of our Patient Advocates to learn more.

It is difficult to predict the timeline of a patients response. Every patient responds differently to treatment. It could take weeks to months for the stem cells to provide noticeable results.

Typically patients will experience some level of soreness and bruising lasting roughly a week as a result of the mini-liposuction procedure. Additional complications have not been observed. Over a hundred studies and clinical trials have demonstrated the safety and minimal side-effect profile of stem cell therapy.

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Stem Cell Treatment & Therapy for COPD | Pulmonary Disease

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Diabetes – Diagnosis and treatment – Mayo Clinic

July 23rd, 2018 12:42 am

Diagnosis

Symptoms of type 1 diabetes often appear suddenly and are often the reason for checking blood sugar levels. Because symptoms of other types of diabetes and prediabetes come on more gradually or may not be evident, the American Diabetes Association (ADA) has recommended screening guidelines. The ADA recommends that the following people be screened for diabetes:

Glycated hemoglobin (A1C) test. This blood test, which doesn't require fasting, indicates your average blood sugar level for the past two to three months. It measures the percentage of blood sugar attached to hemoglobin, the oxygen-carrying protein in red blood cells.

The higher your blood sugar levels, the more hemoglobin you'll have with sugar attached. An A1C level of 6.5 percent or higher on two separate tests indicates that you have diabetes. An A1C between 5.7 and 6.4 percent indicates prediabetes. Below 5.7 is considered normal.

If the A1C test results aren't consistent, the test isn't available, or you have certain conditions that can make the A1C test inaccurate such as if you're pregnant or have an uncommon form of hemoglobin (known as a hemoglobin variant) your doctor may use the following tests to diagnose diabetes:

Oral glucose tolerance test. For this test, you fast overnight, and the fasting blood sugar level is measured. Then you drink a sugary liquid, and blood sugar levels are tested periodically for the next two hours.

A blood sugar level less than 140 mg/dL (7.8 mmol/L) is normal. A reading of more than 200 mg/dL (11.1 mmol/L) after two hours indicates diabetes. A reading between 140 and 199 mg/dL (7.8 mmol/L and 11.0 mmol/L) indicates prediabetes.

If type 1 diabetes is suspected, your urine will be tested to look for the presence of a byproduct produced when muscle and fat tissue are used for energy because the body doesn't have enough insulin to use the available glucose (ketones). Your doctor will also likely run a test to see if you have the destructive immune system cells associated with type 1 diabetes called autoantibodies.

Your doctor will likely evaluate your risk factors for gestational diabetes early in your pregnancy:

Your doctor may use the following screening tests:

Initial glucose challenge test. You'll begin the glucose challenge test by drinking a syrupy glucose solution. One hour later, you'll have a blood test to measure your blood sugar level. A blood sugar level below 140 mg/dL (7.8 mmol/L) is usually considered normal on a glucose challenge test, although this may vary at specific clinics or labs.

If your blood sugar level is higher than normal, it only means you have a higher risk of gestational diabetes. Your doctor will order a follow-up test to determine if you have gestational diabetes.

Follow-up glucose tolerance testing. For the follow-up test, you'll be asked to fast overnight and then have your fasting blood sugar level measured. Then you'll drink another sweet solution this one containing a higher concentration of glucose and your blood sugar level will be checked every hour for a period of three hours.

If at least two of the blood sugar readings are higher than the normal values established for each of the three hours of the test, you'll be diagnosed with gestational diabetes.

Depending on what type of diabetes you have, blood sugar monitoring, insulin and oral medications may play a role in your treatment. Eating a healthy diet, maintaining a healthy weight and participating in regular activity also are important factors in managing diabetes.

An important part of managing diabetes as well as your overall health is maintaining a healthy weight through a healthy diet and exercise plan:

Healthy eating. Contrary to popular perception, there's no specific diabetes diet. You'll need to center your diet on more fruits, vegetables, lean proteins and whole grains foods that are high in nutrition and fiber and low in fat and calories and cut down on saturated fats, refined carbohydrates and sweets. In fact, it's the best eating plan for the entire family. Sugary foods are OK once in a while, as long as they're counted as part of your meal plan.

Yet understanding what and how much to eat can be a challenge. A registered dietitian can help you create a meal plan that fits your health goals, food preferences and lifestyle. This will likely include carbohydrate counting, especially if you have type 1 diabetes.

Physical activity. Everyone needs regular aerobic exercise, and people who have diabetes are no exception. Exercise lowers your blood sugar level by moving sugar into your cells, where it's used for energy. Exercise also increases your sensitivity to insulin, which means your body needs less insulin to transport sugar to your cells.

Get your doctor's OK to exercise. Then choose activities you enjoy, such as walking, swimming or biking. What's most important is making physical activity part of your daily routine.

Aim for at least 30 minutes or more of aerobic exercise most days of the week. Bouts of activity can be as brief as 10 minutes, three times a day. If you haven't been active for a while, start slowly and build up gradually.

Treatment for type 1 diabetes involves insulin injections or the use of an insulin pump, frequent blood sugar checks, and carbohydrate counting. Treatment of type 2 diabetes primarily involves lifestyle changes, monitoring of your blood sugar, along with diabetes medications, insulin or both.

Monitoring your blood sugar. Depending on your treatment plan, you may check and record your blood sugar as many as four times a day or more often if you're taking insulin. Careful monitoring is the only way to make sure that your blood sugar level remains within your target range. People with type 2 diabetes who aren't taking insulin generally check their blood sugar much less frequently.

People who receive insulin therapy also may choose to monitor their blood sugar levels with a continuous glucose monitor. Although this technology hasn't yet completely replaced the glucose meter, it can significantly reduce the number of fingersticks necessary to check blood sugar and provide important information about trends in blood sugar levels.

Even with careful management, blood sugar levels can sometimes change unpredictably. With help from your diabetes treatment team, you'll learn how your blood sugar level changes in response to food, physical activity, medications, illness, alcohol, stress and for women, fluctuations in hormone levels.

In addition to daily blood sugar monitoring, your doctor will likely recommend regular A1C testing to measure your average blood sugar level for the past two to three months.

Compared with repeated daily blood sugar tests, A1C testing better indicates how well your diabetes treatment plan is working overall. An elevated A1C level may signal the need for a change in your oral medication, insulin regimen or meal plan.

Your target A1C goal may vary depending on your age and various other factors, such as other medical conditions you may have. However, for most people with diabetes, the American Diabetes Association recommends an A1C of below 7 percent. Ask your doctor what your A1C target is.

Insulin. People with type 1 diabetes need insulin therapy to survive. Many people with type 2 diabetes or gestational diabetes also need insulin therapy.

Many types of insulin are available, including rapid-acting insulin, long-acting insulin and intermediate options. Depending on your needs, your doctor may prescribe a mixture of insulin types to use throughout the day and night.

Insulin can't be taken orally to lower blood sugar because stomach enzymes interfere with insulin's action. Often insulin is injected using a fine needle and syringe or an insulin pen a device that looks like a large ink pen.

An insulin pump also may be an option. The pump is a device about the size of a cellphone worn on the outside of your body. A tube connects the reservoir of insulin to a catheter that's inserted under the skin of your abdomen.

A tubeless pump that works wirelessly also is now available. You program an insulin pump to dispense specific amounts of insulin. It can be adjusted to deliver more or less insulin depending on meals, activity level and blood sugar level.

An emerging treatment approach, not yet available, is closed loop insulin delivery, also known as the artificial pancreas. It links a continuous glucose monitor to an insulin pump, and automatically delivers the correct amount of insulin when needed.

There are a number of versions of the artificial pancreas, and clinical trials have had encouraging results. More research needs to be done before a fully functional artificial pancreas receives regulatory approval.

However, progress has been made toward an artificial pancreas. In 2016, an insulin pump combined with a continuous glucose monitor and a computer algorithm was approved by the Food and Drug Administration. However, the user still needs to tell the machine how many carbohydrates will be eaten.

Oral or other medications. Sometimes other oral or injected medications are prescribed as well. Some diabetes medications stimulate your pancreas to produce and release more insulin. Others inhibit the production and release of glucose from your liver, which means you need less insulin to transport sugar into your cells.

Still others block the action of stomach or intestinal enzymes that break down carbohydrates or make your tissues more sensitive to insulin. Metformin (Glucophage, Glumetza, others) is generally the first medication prescribed for type 2 diabetes.

Transplantation. In some people who have type 1 diabetes, a pancreas transplant may be an option. Islet transplants are being studied as well. With a successful pancreas transplant, you would no longer need insulin therapy.

But transplants aren't always successful and these procedures pose serious risks. You need a lifetime of immune-suppressing drugs to prevent organ rejection. These drugs can have serious side effects, which is why transplants are usually reserved for people whose diabetes can't be controlled or those who also need a kidney transplant.

Bariatric surgery. Although it is not specifically considered a treatment for type 2 diabetes, people with type 2 diabetes who are obese and have a body mass index higher than 35 may benefit from this type of surgery. People who've undergone gastric bypass have seen significant improvements in their blood sugar levels. However, this procedure's long-term risks and benefits for type 2 diabetes aren't yet known.

Controlling your blood sugar level is essential to keeping your baby healthy and avoiding complications during delivery. In addition to maintaining a healthy diet and exercising, your treatment plan may include monitoring your blood sugar and, in some cases, using insulin or oral medications.

Your doctor also will monitor your blood sugar level during labor. If your blood sugar rises, your baby may release high levels of insulin which can lead to low blood sugar right after birth.

If you have prediabetes, healthy lifestyle choices can help you bring your blood sugar level back to normal or at least keep it from rising toward the levels seen in type 2 diabetes. Maintaining a healthy weight through exercise and healthy eating can help. Exercising at least 150 minutes a week and losing about 7 percent of your body weight may prevent or delay type 2 diabetes.

Sometimes medications such as metformin (Glucophage, Glumetza, others) also are an option if you're at high risk of diabetes, including when your prediabetes is worsening or if you have cardiovascular disease, fatty liver disease or polycystic ovary syndrome.

In other cases, medications to control cholesterol statins, in particular and high blood pressure medications are needed. Your doctor might prescribe low-dose aspirin therapy to help prevent cardiovascular disease if you're at high risk. However, healthy lifestyle choices remain key.

Because so many factors can affect your blood sugar, problems may sometimes arise that require immediate care, such as:

Increased ketones in your urine (diabetic ketoacidosis). If your cells are starved for energy, your body may begin to break down fat. This produces toxic acids known as ketones. Watch for loss of appetite, weakness, vomiting, fever, stomach pain and a sweet, fruity breath.

You can check your urine for excess ketones with an over-the-counter ketones test kit. If you have excess ketones in your urine, consult your doctor right away or seek emergency care. This condition is more common in people with type 1 diabetes.

Hyperglycemic hyperosmolar nonketotic syndrome. Signs and symptoms of this life-threatening condition include a blood sugar reading over 600 mg/dL (33.3 mmol/L), dry mouth, extreme thirst, fever, drowsiness, confusion, vision loss and hallucinations. Hyperosmolar syndrome is caused by sky-high blood sugar that turns blood thick and syrupy.

It is seen in people with type 2 diabetes, and it's often preceded by an illness. Call your doctor or seek immediate medical care if you have signs or symptoms of this condition.

Low blood sugar (hypoglycemia). If your blood sugar level drops below your target range, it's known as low blood sugar (hypoglycemia). If you're taking medication that lowers your blood sugar, including insulin, your blood sugar level can drop for many reasons, including skipping a meal and getting more physical activity than normal. Low blood sugar also occurs if you take too much insulin or an excess of a glucose-lowering medication that promotes the secretion of insulin by your pancreas.

Check your blood sugar level regularly, and watch for signs and symptoms of low blood sugar sweating, shakiness, weakness, hunger, dizziness, headache, blurred vision, heart palpitations, irritability, slurred speech, drowsiness, confusion, fainting and seizures. Low blood sugar is treated with quickly absorbed carbohydrates, such as fruit juice or glucose tablets.

Explore Mayo Clinic studies testing new treatments, interventions and tests as a means to prevent, detect, treat or manage this disease.

Diabetes is a serious disease. Following your diabetes treatment plan takes round-the-clock commitment. Careful management of diabetes can reduce your risk of serious even life-threatening complications.

Make physical activity part of your daily routine. Regular exercise can help prevent prediabetes and type 2 diabetes, and it can help those who already have diabetes to maintain better blood sugar control. A minimum of 30 minutes of moderate exercise such as brisk walking most days of the week is recommended.

A combination of exercises aerobic exercises, such as walking or dancing on most days, combined with resistance training, such as weightlifting or yoga twice a week often helps control blood sugar more effectively than does either type of exercise alone.

It's also a good idea to spend less time sitting still. Try to get up and move around for a few minutes at least every 30 minutes or so when you're awake.

In addition, if you have type 1 or type 2 diabetes:

Keep your vaccinations up-to-date. High blood sugar can weaken your immune system. Get a flu shot every year, and your doctor may recommend the pneumonia vaccine, as well. The Centers for Disease Control and Prevention (CDC) also currently recommends hepatitis B vaccination if you haven't previously been vaccinated against hepatitis B and you're an adult ages 19 to 59 with type 1 or type 2 diabetes.

The most recent CDC guidelines advise vaccination as soon as possible after diagnosis with type 1 or type 2 diabetes. If you are age 60 or older, have diabetes, and haven't previously received the vaccine, talk to your doctor about whether it's right for you.

If you drink alcohol, do so responsibly. Alcohol can cause either high or low blood sugar, depending on how much you drink and if you eat at the same time. If you choose to drink, do so only in moderation one drink a day for women and two drinks a day for men and always with food.

Remember to include the carbohydrates from any alcohol you drink in your daily carbohydrate count. And check your blood sugar levels before going to bed.

Numerous substances have been shown to improve insulin sensitivity in some studies, while other studies fail to find any benefit for blood sugar control or in lowering A1C levels. Because of the conflicting findings, there aren't any alternative therapies that are currently recommended to help everyone with blood sugar management.

If you decide to try any type of alternative therapy, don't stop taking the medications that your doctor has prescribed. Be sure to discuss the use of any of these therapies with your doctor to make sure that they won't cause adverse reactions or interact with your current therapy.

Additionally, there are no treatments alternative or conventional that can cure diabetes, so it's critical that people who are receiving insulin therapy for diabetes don't stop using insulin unless directed to do so by their physicians.

Living with diabetes can be difficult and frustrating. Sometimes, even when you've done everything right, your blood sugar levels may rise. But stick with your diabetes management plan, and you'll likely see a positive difference in your A1C when you visit your doctor.

Because good diabetes management can be time-consuming, and sometimes overwhelming, some people find it helps to talk to someone. Your doctor can probably recommend a mental health professional for you to speak with, or you may want to try a support group.

Sharing your frustrations and your triumphs with people who understand what you're going through can be very helpful. And you may find that others have great tips to share about diabetes management.

Your doctor may know of a local support group, or you can call the American Diabetes Association at 800-DIABETES (800-342-2383) or the Juvenile Diabetes Research Foundation at 800-533-CURE (800-533-2873).

You're likely to start by seeing your primary care doctor if you're having diabetes symptoms. If your child is having diabetes symptoms, you might see your child's pediatrician. If blood sugar levels are extremely high, you'll likely be sent to the emergency room.

If blood sugar levels aren't high enough to put you or your child immediately at risk, you may be referred to a doctor who specializes in diabetes, among other disorders (endocrinologist). Soon after diagnosis, you'll also likely meet with a diabetes educator and a dietitian to get more information on managing your diabetes.

Here's some information to help you get ready for your appointment and to know what to expect.

Preparing a list of questions can help you make the most of your time with your doctor. For diabetes, some questions to ask include:

Your doctor is likely to ask you a number of questions, such as:

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Diabetes - Diagnosis and treatment - Mayo Clinic

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Scientists edit heart muscle gene in stem cells, may be …

July 22nd, 2018 11:44 am

Story highlights

In other words, the impact certain variants could have on your health remains a guessing game.

"Patients often ask us what do these variants of uncertain significance mean. But in reality, we don't know most of the time ourselves. So we end up having to follow the patients for the next five, 10, 20, or 30 years to see if the patient manifests the disease or not," Wu said.

"Here, we now have a way to shorten that time because we can generate patients' induced pluripotent stem cells from blood."

How do those stem cells then help predict if a variant is harmful or not? They can be differentiated into heart cells.

If the heart cells look abnormal, that probably means the variant of uncertain significance is pathogenic, meaning it's capable of causing disease.

If the heart cells look normal, that probably means the variant of uncertain significance is actually benign.

"This is one of the very first proof of principles to show that concept," Wu said.

'An important step towards precision medicine'

The researchers found 592 genetic variants across the 54 people. While 78% of the variants were categorized as benign, there were 17 people who each carried a variant categorized as "likely pathogenic." For four of those people, their variant was hypertrophic cardiomyopathy-related.

So the researchers then took that knowledge and used CRISPR to turn the patient's stem cells with this MYL3 genetic variant from being heterozygous, meaning they have one normal and one recessive form of the variant, to being homozygous, so that they have two recessive forms of the variant.

Specifically, the researchers took the one study participant's blood cells, turned them into induced pluripotent stem cells, and then used CRISPR to edit those cells in a petri dish. The researchers then differentiated the edited stem cells so they would become heart muscle cells, and performed a comprehensive analysis to evaluate the variant, determining exactly how harmful the variant was or whether it was benign.

In this case, the study participant's variant was predicted to be benign.

A risk with using CRISPR is that it could introduce some unintended changes, but no off-target mutations were detected in the gene-edited cells, the researchers reported in their study.

"Much work remains to further develop stepping stones between editing cells in a dish and genome editing therapeutics that can treat patients, but studies such as this one help identify variants that are promising targets for therapeutic editing," said David Liu, core institute member of the Broad Institute and professor of chemistry and chemical biology at Harvard University, who was not involved in the study.

This gene-editing approach was found to be feasible in this one patient, but more research is needed to determine whether similar results would emerge among more patients.

"While it's very elegant, the major limitation of this work is that it took years of expensive work by a team of very talented scientists to do this for just one patient," said Dr. Kiran Musunuru, an associate professor of cardiovascular medicine at the University of Pennsylvania's Perelman School of Medicine, who was not involved in the new study but has conducted separate research involving CRISPR.

"It's an important step towards precision medicine, but going forward we will need to scale this up and be able to do this for dozens, hundreds, or even thousands of patients at a time, in a matter of weeks and much more cheaply," he said.

Time and cost are also limitations of this approach, Wu said.

"Cost-wise, it takes us probably about $10,000 and time-wise about six months," he said. Those six months would involve making the induced pluripotent stem cells, using CRISPR to edit the cells and then analyzing the differentiated heart cells.

Wu added, "but keep in mind that six months is actually still much better than the current alternative that we have, which is to tell patients that we don't know what the variant means."

The alternative would be following a patient with a variant for years, with the worrisome chance of a disease possibly developing or not developing. In either scenario, the patient as well as family members could have anxiety and stress.

Is this the future of gene editing?

"This addresses a major unmet need in patient care by helping determine whether your specific mutation is something to worry about," said Lagor, who was not involved in the study but has conducted separate research on CRISPR.

Then once a mutation has been identified as disease-causing, "this is an ideal platform for testing potential new drugs or gene therapy approaches in a patient-specific manner. This is truly personalized medicine," he said.

"The first therapeutic application of this technology would be to correct rare genetic diseases of the heart itself, where the potential benefit far outweighs the risk to the patient. Some of this technology already exists today, and it is now a matter of demonstrating that this can be done safely and effectively," he said.

"However, present-day forms of CRISPR technology do not work well enough in the actual heart muscle in a living being to correct a mutation for a disease like cardiomyopathy," he said. "It's possible that some future generation of gene-editing technology might be able to do the job of treating disease in the heart muscle, years or more likely decades in the future."

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The Promise of Nanomedicine – Laboratory Equipment

July 22nd, 2018 11:42 am

More than a decade ago, nanotechnology became an integral part of the overall scientific research world. Governments started funding programs specifically aimed at nanotechnology, research universities opened their facilities and coursework to the new discipline, and journals focusing on nano research became commonplace.And now, many researchers believe, its nanomedicines turn to do the same. Nanomedicinewhich has emerged as nanotechnologys most important sub-disciplineis the application of nanotechnology to the prevention and treatment of disease in the human body. It is already having an impact clinically among some of the deadliest diseases in the world.

Nanomedicine is far from the stuff of science fiction. The possibilities for nanomedicine to help us diagnose, treat and image diseases are endless. Imagine a smart nanomedicine that is able to bind to tumor cells and enhance imaging and diagnosis, at the same time as being able to deliver a gene therapy or chemotherapy agent. With the technologies available to us and our multidisciplinary teams, this will be possible in my lifetime, said Phoebe Phillips, head of the pancreatic cancer translational research group at the University of New South Wales in Sydney.

Phillips and her team have created a nanoparticle that dramatically increases its effectiveness as an anti-cancer drug for patients with pancreatic cancers, which is one of the fastest killing cancers from time of initial detection, often leaving patients with no suitable treatment options and only weeks to live.

While nanomedicine canand likely willplay a role in diagnostics, regenerative medicine, prosthetics and more, the effect the sub-discipline is currently having on the treatment of autoimmune diseases and cancers is significant.

Nanomedicine for HIVThirty years ago, a diagnosis of HIV/AIDS was essentially a guarantee of a painful, protracted death. It wasnt until 1996 that researchers discovered antiretroviral drugs, and the potent combination therapy that leads to successful management of HIV/AIDS in most cases. However, not much has changed since that discovery. Those suffering from the autoimmune disease still require daily oral dosing of three to four pills, and chronic oral dosing has significant complications that can arise from the high pill burden experienced by patients, leading to non-adherence to therapies for a variety of reasons.

Ive been working in HIV for over 20 years, Andrew Owen, professor of molecular and clinical pharmacology at the University of Liverpool (UK) told Laboratory Equipment. I was trying to understand the variability in drug exposure that occurs between different individuals and the genetic basis for that. We were finding a lot of interesting things, but they werent clinically implementable. They gave us a good understanding of why drug exposure was variable, but it didnt actually help the patients in any way.

In an attempt to solve the problem rather than just characterize it, Owen turned to nanomedicine in 2009, eventually becoming part of the first team to conduct human trials of orally dosed nanomedicines for HIV. Since then, Owen and his interdisciplinary team at the Liverpool Nanomedicine Partnership have secured more than 20 million of research funding for a multitude of nanomedicine-based approaches to HIV, such low-dose oral delivery, long-acting injectable medications and targeted delivery of antiretrovirals.

Some of Owens most important research to date tackles two of the pharmaceutical industrys biggest challenges: oral delivery of potent drugs and supply and demand.

One of the major problems that has plagued drug discovery and drug development over the last 30 years has been compatibility with oral drug delivery, Owen explained. The pharmaceutical industry has wrestled with that because they can develop very potent molecules across diseases, but actually delivering those molecules orally is very challenging. As you try to design into the molecule oral bioavailabilty, you usually get further away from the potency you want.

The Liverpool team solved this problem with the creation of Solid Drug Nanoparticles. The technology consists of combining a normal drug, in its solid form, with particles on that drug that are measurable within the nanometer scale. There are other things packed into the formulation as well, such as FDA-approved stabilizers that are proven to help disperse the drug. Owen says it is all about increasing the surface area covered by the drug.

If you imagine you take a granulated form of the drug, youre going to get big chunks of drugs in the intestinal tract when dissolution happens. But if you have nanometer-sized particles within the GI tract, then you are going to get a complete coating of the inside of the intestine after you take the drug, Owen explained. What that does is it massively increases the surface area covered by the drug, which saturates all sorts of drug influx processes within the GI tract.

Since 80 percent of a humans immune system is concentrated in the gut, the Solid Drug Nanoparticles are the perfect mechanism. The immune cells in the gut instinctually move toward the particles, creating a pathway for the drugs to cross the intestines, move through the lymphatic system, and finally into the systematic circulation.

In February, Owen presented the results of two trials at the Conference on Retroviruses and Opportunistic Infections (CROI) that confirmed his Solid Drug Nanoparticles can be effective at a 50 percent dose reduction. Specifically, Owen and his team applied the nanomedicine-based approach to the formulation of two drugs: efvirenz (EFV) and lopinavir (LPV). EFV is the current WHO-recommended regimen, with 70 percent of adult HIV patients in low- and middle-income countries taking the medication. At 50 percent of the dose, the patients in the trial were able to maintain plasma concentrations of the conventional dose.

Globally, the supply of drugs needed to treat every patient with HIV is outstripping manufacturing capabilitymeaning we, as a human species, cannot physically make enough HIV medication to treat everyone with the disease. A 50 percent reduction in dose means twice as many patients served with the existing drug supply.Owen and his team are working with multiple global partners to move the technology forward. For the drugs already formulated, the Medicines Patent Pool and Clinical Health Access are helping to scale up and take them to market. Meanwhile, USAIDs Project OPTIMIZE is applying the nanoparticle technology to the newest HIV drugs for use in low- and middle-income countries.

For their latest collaboration with Johns Hopkins University, the Liverpool team was just awarded $3 million to examine the use of implantable technologies that can deliver drugs for weeks, or even months.

The current oral drug regimens for HIV comprises three drugs in combinationone is the major driver for efficacy, and the other two are nucleoside reverse transcriptase inhibitors that prevent resistance to the main drug. However, current injectable formulations are only available with the main drugnone include the nucleoside reverse transcriptase inhibitors.

So, our project aims to develop the first long-acting injectable nucleoside reverse transcriptase inhibitors so that we can use them to have a fully long-acting regimen that matches the current clinical paradigm for therapy, Owen said.

The Liverpool/Hopkins team has also thought about applying their long-acting injectable technology to other chronic diseases, such as malaria and tuberculosis, as well as some cardiovascular applications.

Nanomedicine for diabetesWhen the nanoparticles he was working with as an imaging tool didnt produce the desired results, Pere Santamaria grew frustratedbut he didnt give up. Instead, the doctor and professor at the University of Calgary (Canada) changed his assumptions and pursued his experimentuntil the data came pouring in that confirmed it wasnt a failed experiment at all. Rather, it was a discovery.

The discovery of Navacims was a bit serendipitous, Santamaria told Laboratory Equipment. Thankfully I am a little OCD and I didnt let the failed experiment go.Navacims are an entirely new class of nanomedicine drugs that harness the ability to stop disease without impairing normal immunity. Santamaria has been studying Navacims for the past 17 years, ever since unintentionally developing them. He even started a spin-off company, Parvus Therapeutics, Inc., to help bring the drugs to market.

In autoimmune diseases, white blood cells, which are normally responsible for warding off foreign invaders and disease, turn on the body, attacking the good cells and causing their destruction. Each specific autoimmune disease results from an attack against thousands of individual protein fragments in the targeted organ, such as the insulin-producing pancreatic cells in the case of type 1 diabetes.

But Santamarias studies show that nanoparticles decorated with protein targets acting as bait for disease-causing white blood cells can actually be used to reprogram the cells to rightfully suppress the disease they once intended to cause.

Once the immune system recognizes the presence of a Navacim, a white blood cell is reprogrammed by epigenetic changes into a lymphocyte that no longer wants to cause tissue damage, but rather work to suppress disease. According to Santamaria, the reprogramming step is immediately followed by an expansion of that population of lymphocytesone now-good white blood cell dividing into a million.

Basically they turn the tables on the immune system, and then there is a very sophisticated series of downstream cellular events that arise from that reprogramming event that involves the recruitment of other lymphocytes and other cell types that completely suppress the inflammation in the organ that is being infected, Santamaria explained. This happens extremely efficiently and comprehensively. This is an approach that can efficiently, selectively and specifically blend a complex response without impairing basic immunity.

In addition, the design of Navacims is modular, meaning the nanomedicine can be applied to severalif not allautoimmune diseases, including multiple sclerosis and rheumatoid arthritis. Navacims can be altered to target different diseases by simply changing a small portion of the bait molecules on the nanoparticles. Santamarias studies have shown this to work in about seven autoimmune diseases thus far.

In April, Santamarias company Parvus entered into a license and collaboration agreement with Novartis for Navacims. Under the terms of the agreement, Novartis receives exclusive worldwide rights to use Parvus Navacim technology to develop and commercialize products for the treatment of type 1 diabetes, and will be responsible for clinical-stage development and commercialization. Parvus will still be responsible for conducting ongoing preclinical work in the diabetes area, with some research funding from Novartis.

Weve had such a long time to prove ourselves, that this is not a flash in the pan, that this is something serious and robust, Santamaria said. We know so much about the mechanisms of our actions, and so much granularity. I think there are no other drugs that have reached the clinic with this level of understanding. That was painful in the beginning for us, but in the end its going to be good.

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The Legal and Regulatory Context for Human Gene Editing …

July 22nd, 2018 11:42 am

The potential use of human gene editing is stimulating discussions and responses in every country. I will attempt to provide an overview of legal and regulatory initiatives around the globe. But I need to note that we are talking not only about government when we talk about law, regulation, and biotechnology. We are really talking essentially about an ecosystem that is made up of government, the public, and private industry, which produces innovative products based on the basic science and applied research coming out of our universities.

The ecology of this system is one in which there are many legal or policy issues that combine to affect whether biotechnology is promoted or hindered in any particular country. It ranges from topics such as intellectual property rights, which are reflected in areas from patent policy, to international trade laws, which will have a huge effect on whether or not the new products are going to be able to cross borders easily and under what conditions. The regulatory framework is going to determine the speed at which biotechnology moves from laboratory to development to marketed product.

The consumer demand will also be a profoundly important feature in determining which products are developed, because so many discoveries do not lead to something that the public wants or needs, or that it knows it wants and needs. This will also be affected by variables such as stigma and cultural attitudes.

Last of course, but certainly not least, are areas of public research and investment. All of these together are going to combine into a vision of how a particular country moves or does not move biotechnology. Some of the categories that have been proposed by other scholars range from promotional, in which a country is actually pushing the innovation; to a more neutral stance, in which it simply proceeds or not with as little government direction as possible; to precautionary; to an absolutely prohibitive system that either defunds entirely or even makes criminal the technology.

It is worth keeping in mind that within a country, one can have very different attitudes about different aspects of biotechnology. For example, the United States has a fairly permissive approach to biotechnology applied to genetically engineered animals and plants in the agricultural sector, whereas it has a much more cautious approach when it comes to the use of biotechnology in the context of human clinical care and therapies. There does not have to be a single approach to biotechnology across all application areas. There can be differences among countries and even within a country.

One can also look at how different areas of policy can be tied to one or another of these visions of an overall biotechnology direction. For example, strong patent protection can be viewed as promotional because it gives industry the greatest possible financial incentive to pursue particular application areas. However, from the basic science and research community point of view, strong patent protection can sometimes be perceived as slowing the ability to collaborate or take advantage of one anothers work.

In the area of biosafety, we see more case-by-case evaluation of biotechnology products, where everything really begins to hinge simply on the presumption about risk. One can take a precautionary approach that presumes it is dangerous until it is proven safe, or a permissive approach that presumes it is safe until it is proven dangerous. Since it is often impossible to prove either danger or safety, where that presumption falls will often be more determinative than anything else in deciding how quickly technologies move from the basic science laboratory to clinical research to application.

Finally, in the area of public information, there is a very lively debate going on, particularly in the United States, about the labeling of foods that have some component that involves modern biotechnology. For example, now that the Food and Drug Administration (FDA) has approved the sale of a genetically modified farmed salmon, there is a debate about whether that salmon has to be identified for consumers.

If we have systems that carefully distinguish between those things that are the products of modern biotechnology and those that arent, we could be setting ourselves up for a more precautionary regulatory approach because it will tie into public attitudes that are often based on concern about either the corporate influence or the actual underlying science. On the other hand, if regulation is mandated only when there is evidence of a higher level of risk, products will reach the market more quickly, reflecting a more promotional stance.

To implement any one of these approaches, we have a variety of mechanisms that range from the least to the most enforceable. Public consultation is the least enforceable approach, and there is a spectrum of regulatory and legislative measures that can strengthen the level of control.

In the area of public consultation, we have numerous examples from around the world. In the United States, the National Environmental Policy Act is unusual among environmental laws because rather than telling individuals or companies what they can and cannot do, it simply provides that when the government makes a particular decision, it must be subjected to a higher degree of public scrutiny than is typical. The catchword for this approach is that sunlight is the best disinfectant. By incorporating public comment, it creates political pressure that can drive decisions in one way or another, and it allows for some interplay between government expertise and public consultation. We see other examples of it in the approval process for products such as engineered salmon, which required a number of public hearings.

Canada, when it looked at assisted reproduction, formed a royal commission on new reproductive technologies that held hearings on the topic across the country. In the European Union (EU), genetically engineered foods, or GMOs as they are usually referred to there, are of special concern. There is actually an EU directive requiring that there be a degree of public access to information whenever a product potentially affects biodiversity or other environmental elements.

Public consultation is considered an alternative to a centralized directive form of governance. One simply creates the situation in which the public can, through its own decentralized processes, exert pressure on government or on industry and thereby alter the direction or the speed of biotechnology innovation.

Next in this hierarchy of enforceability comes voluntary self-regulation. The 1975 Asilomar conference on recombinant DNA technology was one of the more notable examples of voluntary self-regulation by the scientific community when it recognized that there were certain risks that needed to be investigated before it pushed forward at full speed. The research community voluntarily imposed on itself moratoria on certain applications and implemented a series of precautionary measures having to do with containment of possibly dangerous materials. A more recent example is the set of guidelines for human embryonic stem cell research, which were developed by the U.S. National Academies and the International Society for Stem Cell Research.

What is interesting about these instances of self-regulation is that unlike the government-imposed rules, these were truly self-imposed rules that were seriously constraining in many ways. They often called for prohibiting payment for certain materials and services in ways that limited the ability of the scientific community to move as quickly as it might want. For example, it limited the use of chimeras and established strict guidelines on the distribution of the gametes and embryos needed for research.

It was a success in the sense that it forestalled what might have been really onerous government action at the state or federal levels, and it demonstrated that self-regulation could be flexible and nuanced without sacrificing reliability. The self-regulatory approach has also been used in the case of gain of function research, a very awkward name for research that increases the pathogenicity, transmissibility, or resistance to countermeasures of known pathogens.

Interestingly, these kinds of voluntary self-regulatory activities often lead directly into some government adoption by proxy of much of the content of the self-imposed rules. For example, in the gain of function area, some of the self-imposed rules led to a National Academies report, which then led, in turn, to the creation of the National Scientific Advisory Board for Biosecurity, which collaborates with its counterparts around the world to manage situations where there is fear that publishing key data will facilitate the transformation of useful biotechnology into bioterrorism.

There are government guidelines in other areas as well. These provisions technically are not enforceable, and yet they are very strongly persuasive because complying with them creates what essentially is a safe haven for companies. They know that if they stay within these guidelines, they are not going to run afoul of some actual regulation or law. These guidelines also create strong social norms.

At the international level, there is the Council for International Organizations of Medical Sciences (CIOMS), which is very influential in creating global standards for research on human subjects. It refers back specifically to the Nuremberg protocols and has the ability to be more restrictive than any particular national set of rules.

That doesnt mean that national laws will necessarily follow, but it establishes a norm from which nations feel free to deviate only when they can provide justification that it is necessary to achieve some public benefit. Therefore, the CIOMS becomes extremely influential, even if not enforceable.

At the far end of the spectrum, of course, we have regulation and legislation. For example, many nations have laws that specifically ban human cloning, although the United States is not one of them. That is not to say that it actually happens in the United States; it is just that there is no U.S. legislation that explicitly bans it. The U.S. regulatory system could, in theory, approve it, but it has never indicated any particular willingness to do so. Effectively, it is impossible to do it legally in the United States, but it is not considered a ban.

We should keep in mind that legislation has the advantage of being more politically credible, particularly in more or less functioning democracies, because it is seen as a product of elected representatives. On the other hand, legislation is extremely rigid and difficult to change. Once it is in place, it can be impossible to remove it, and it is often resistant to nuance. Therefore, it can be a very blunt instrument.

Regulationthat is, the detailed administrative rules adopted pursuant to legislative direction and authorityhas the ability to be much more responsive and detailed, and is influenced to a greater extent by expert information. Yet, it also begins to become somewhat more divorced from public sentiment and begins to move into the world of the administrative state where there is rule by expert, which has its own challenges for democratic systems.

Looking specifically at regulation of human germline modification, a 2014 survey of 39 countries by Motoko Araki and Tetsuya Ishii found a variety of regulatory approaches. Many European countries legally prohibit any intervention in the germline. Other countries have advisory guidelines. The United States has a complicated regulatory scheme that would make it very difficult to perform any germline modification. There are also funding restrictions on embryo research that might have a very strong effect on the underlying basic science needed to even get to the point of regulatory approval. And many countries have simply not considered the possibility.

There are international instruments that have been written at various levels to address aspects of genetics. For example, the Council of Europes Oviedo Convention says that predictive genetic tests should be used only for medical purposes. It specifically calls for a prohibition on the use of genetic engineering of the germline or changing the makeup of later generations. It builds on earlier European conventions.

But like many international instruments, it is not ratified by every member country and, even when ratified, has not necessarily been implemented with concrete legislation. It has great normative value and can occasionally have enforcement-level value, but it is often lacking in the latter.

In the United States, gene therapy is handled in a regulatory system that treats it as a biological drug or a device, depending on its mode of operation. It comes under the comprehensive regulation of the FDA and under multiple laws focusing on infection control, efficacy, and safety.

The United States also seeks guidance from advisory bodies such as the Recombinant DNA Advisory Committee and the local research subjects review bodies that help to make sure that human clinical trials are managed in a way that agrees with the countrys norms and regulations.

But what is perhaps distinctive about the United States is that although it has very strong controls in the pre-market stage of these technologies, once a drug, device, or biologic is on the market, the control becomes much weaker. That is, the United States regulates the products, but not the physicians who actually use those products. Physicians have the discretion to take a product that was approved for one purpose and use it for a different purpose, population, or dosage. There are some post-market mechanisms to track the quality of this work and to dial it back, but they are not as strong as in other countries.

Gene therapy in South Korea has a pathway very similar to the one in the United States. Interestingly, South Korea has come to have a focus on innovation, with expanded access to investigational drugs. It is also developing a system of conditional approval, which would allow for some use of a product prior to the accumulation of the level of evidence that is required in systems such as that in the United States.

Again, there are different versions of this. Even in the United States, regulators sometimes accept evidence from surrogate markers of effectiveness, which allows for a faster path to the market. Many other countries are also considering adopting some form of conditional approval.

The United Kingdoms (U.K.) system is a little different because not only is it operating within the context of the EU and its directives, but it has its own very strong pre-market review process. In addition, it has very strong post-market regulation of any procedures involving embryos or human fertilization. Thus, U.K. regulations cover not just the product, but also where the product can be used and by whom.

The EU has also added special provisions for advanced therapy medicinal products. Gene therapy is almost certainly going to be among them, so that there is an extra layer of EU review for quality control at a centralized level.

Japan has a regulatory pathway that tries to identify prospectively those things that are going to be high, medium, or low risk, and to regulate them accordingly. The United States follows a similar process in its regulation of medical devices.

But for drug regulation, the United States treats everything from the beginning as equally dangerous and runs every proposed drug through the same paces of testing for safety and efficacy. By contrast, in Japan, one will see an initial determination about the level of risk that is likely to be present for each proposed drug and the degree of stringency that the regulatory process must apply as a result.

Japan also has recently added a conditional approval pathway specifically for regenerative medicine and gene therapy products. It will be very interesting to see how this operates. It is still new, so the experience is limited.

There is certainly some concern that if new products are put into use too early in controversial fields such as embryonic stem cell research or gene therapy, a single high-profile failure might set back the entire field. In the United States, the death in 1999 of Jesse Gelsinger in a gene therapy trial at the University of Pennsylvania set back the field by years.

One of the challenges with the conditional therapy pathway is to balance the desire to move forward as quickly as possible while avoiding the kinds of adverse outcomes that not only injure individuals, but could slow progress to the point that many individuals who could have benefited in the future are denied the technology because it is delayed so significantly.

Singapore has a risk-based approach similar to Japans. What is interesting in Singapore is that it actually tries to figure out what would be a high- versus low-risk intervention in the area of cell therapy. The variables that are used include whether the manipulation is substantial or minimal, whether the intended use is homologous or non-homologous, and whether it will be combined with a drug, a device, or another biologic.

The only consideration one might add is autologous versus non-autologous use. In Singapore, these distinctions are used to classify the level of risk. In the United States, it is used to determine if the FDA has the jurisdiction to regulate that particular product.

Finally, Brazil provides an example of regulation and governance by accretion. It recently approved laws related specifically to genetically engineered foods, stem cell research, and cell therapy, but they are layered on top of earlier, more general rules: constitutional prohibitions on the sale of any kind of human tissue and 1996 laws on the patenting of human biological materials. Together they are creating a situation of confusion. The result is paralysis while people try to figure out how the laws are going to interact. It is a cautionary tale about how to proceed with legislation against the backdrop of older decisions that may have been made against different imaginary scenarios.

There is a fundamental divide in the world about how we regulate biotechnology that goes beyond the categories of promotional, permissive, or prohibitive. It is whether we think of biotechnology as a thing unto itself, or whether we think of it simply as one more tool that goes into making various products.

If one regulates the technology, one regulates everything about the technology in a comprehensive way. An example is the EUs community strategy, which takes a global approach to the technology that makes it easier for the public to understand the so-called laws on biotechnology. One can focus on key aspects of the science that create key questions about the effects of a particular kind of innovation. Itto makes it possible to have consistent and overarching approaches to questions of great philosophical significance, such as what we mean when we say human dignity or genetic heritage of mankind.

It also has the problem of needing much more specific legislation to focus on individual products because, as is noted in a contrasting system where you regulate the product and not the technology, as is the case in the United States, the technology itself is neither inherently dangerous nor safe. It is dangerous in some contexts and safe in others. In some products, it is easier to predict its effects. In other products, it is much less likely. Some products may have environmental impacts, and for others the impact will be confined to a single individual or a single animal.

Regulating by product gives one the advantage of being able to be much more specific about the degree of risk that is feared or anticipated, and the degree of caution needed, as well as being able to take advantage of mature degrees of expertise in the regulatory pathways appropriate for drugs, foods, and pesticides, and of the expert people who have been implementing those pathways for years.

The trouble is that it can be confusing to the public. If someone asks: what is the law on biotechnology, the answer is that there are 19 different laws that cover drugs, devices, agricultural products, livestock, and so on. To many people, this sounds as if the country is not regulating biotechnology, and it creates the possibility for unintended or even unnoticed gaps among these laws or conflicts among them.

Whenever we are talking about this, whether in the human or non-human application, but particularly in the human, it is important to think about where in the R&D process we want to exercise control. Pre-market control is truly important to avoid the devastating adverse events that can occur if we move too quickly. But if pre-market control is too strong, not only does it slow the technology, but at a business level it creates a barrier to market entry for smaller players. Mature companies with large staffs know how to maneuver the regulatory system. A small company with very low levels of capital and a high burn rate is not necessarily going to be able to survive long enough to deal with a long and difficult pre-market process.

The AquAdvantage salmon that I mentioned earlier is made by a company that has reportedly been on the verge of bankruptcy during the 20-some years that the product was undergoing review. Another company in Canada that was trying to produce a pig that would be less environmentally damaging wound up abandoning this project, in part because that pathway was so long, slow, and expensive. There is a cost to pre-market controls that are so strong that they drive out the small, and often very creative, innovators.

One thing we have learned is that conditions on research grants, whether from government or philanthropies, can also serve as a strong regulator, but one that is much more responsive and much easier to adapt quickly to changing circumstances and changing levels of knowledge.

Finally, harmonization across national borders is crucial. If we want scientists to be able to use one anothers materials, they have to have confidence that the materials were derived and managed in a way that meets everybodys common expectations of both ethical and biomedically safe levels of care.

We want to have uniformly high standards for research and therapy. We want to be able to reduce conflicts and redundancies in review procedures if we want the science to proceed in a way that is efficient as well as responsible. We learned this lesson with the many conflicts among jurisdictions in the area of embryonic stem cell research.

The more that we have effective systems for responsible oversight in the development and deployment of a technology, the more we can take chances. We can move a technology quickly because we have a chance to back up at the end and change course.

Innovation is not something that is in conflict with precaution. They are complementary strategies in which precaution will facilitate innovation and give us the confidence we need to support these new and risk-taking technologies.

R. Alta Charo is Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin.

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Stem Cell Therapy – Cendant Stem Cell Center – Denver …

July 22nd, 2018 11:41 am

Harnessing stem cells to cure disease is the hottest topic in joint injury, knee pain and arthritis treatment today. By using the adult stem cells found in our own bodies, we can amplify and speed up the natural healing process as well as grow new bone and cartilage to rebuild joints without the need for artificial replacements.

At Cendant Stem Cell Centerin Denver and our new Milwaukee Wisconsin clinic, we provide our patients with the most recent technological advancements available for treating orthopedic injuries and conditions. Our Stem Cell therapy procedureprovides treatment to repair damaged cartilage, restore function, eliminate hip, shoulder, back and knee pain and to prevent further joint destruction.

The patients adipose (fat) derived Stem Cells and/or bone marrow derived Stem Cells are injected alongwith Platelet Rich Plasma into the joint capsule space. These components are put on top of an Extracellular Fiber Matrixwhich is injected into the joint capsule before the introduction of Stem Cells. This FDA approved fiberis a major advancement in the Stem Cell procedure which gives Stem Cells a structure to bind and growupon inside the joint space. The technology allows us to treat older patients and patients with more aggressive joint disease who are facing replacement surgery or suffering from chronic pain.

The Stem Cell procedureis virtually painless, takes 3 hours and is performed under local anesthesia. It requires little to no downtime and is effective, fast and safe. Please visit our Video Testimonials page to hear from our patients and why they choose our Denver and Milwaukee stem cell clinics for their medical needs.

Ourunique approach to stem cell therapy does not offer a single franchised solution. Cendants multiple technologies provide case-driven stem cell treatment options to address individual patient needs.

Medical researchers are reporting remarkable results using platelet rich plasma and stem cellsin the treatment of common injuries, including:

What should patients expect after Stem Cell Therapy?

The noticeable regeneration of the joint tissue and cartilage typically starts to occur within 3 weeks. Most of our patients report asubstantialreduction in pain and improved function within 4-6 weeksafter treatment. Many report total pain elimination within 10-12 weeks. Within 3-5 daysafter the procedure, most patients can return to work and resume normal daily activities. Patients cannot start stressful activity or begin strenuous exercise for six weeks. Returning to stressful activity before six weeks may result in incomplete healing of the treated tissue.

Is this therapy safe?

Yes. Autologous PRP therapy and Stem Cell therapy has been used for over 10 years in surgical and orthopedic procedures. There are many research articles published on the safety of these therapies. Because a patients own blood and cells are used, there is little risk of a transmissible infection, no side effects and a very low risk of allergic reaction.

How many treatments are required?

We treat most patients aggressively upon the first visit with a mix of PRP, Extracellular Fiber Matrix and Stem Cells which all work together to create yourregenerative injection. Most patients need only 1 treatment but you could potentially have a follow up pure PRP injection which is thought of as a booster shot, the primary function of which is to stimulate continual stem cell growth.

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