StemCell Therapy

You may get your hair color from your fathers side of the family and your great math skills from your mother. These traits are in the genes, so to speak. Likewise, longevity tends to run in familiesyour genetic make-up plays an important role in how you age. You can see evidence of this genetic connection in families with siblings who live into their 90s or families that have generation after generation of centenarians. These long-lived families are the basis for many genetic studies.

Identifying the genes associated with any trait is difficult. First, just locating the gene requires a detailed understanding of the trait, including knowledge of most, if not all, of the contributing factors and pathways related to that trait. Second, scientists must have clear ways of determining whether the gene suspected to have a relationship with the trait has a direct, indirect, or even no effect on that trait.

Identifying longevity genes is even more complex than determining genes for height or hair color, for example. Scientists do not know all the factors and pathways that contribute to longevity, and measuring a genes effect on long-lived animals, including humans, would literally take a lifetime! Instead, scientists have identified hundreds of genes that affect longevity in short-lived animal models, like worms and flies. Not all of these genes promote long life. Sometimes mutating or eliminating a gene increases lifespan, suggesting that the normal function of the gene limits longevity. Findings in animal models point to places for scientists to look for the genes that may influence longevity in humans.

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GENETICS: Is aging in our genes? - nia.nih.gov

Holistic Medicine Secaucus NJ

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Genomic Medicine

NHGRI defines genomic medicine as "an emerging medical discipline that involves using genomic information about an individual as part of their clinical care (e.g., for diagnostic or therapeutic decision-making) and the health outcomes and policy implications of that clinical use." Already, genomic medicine is making an impact in the fields of oncology, pharmacology, rare and undiagnosed diseases, and infectious disease.

The nation's investment in the Human Genome Project (HGP) was grounded in the expectation that knowledge generated as a result of that extraordinary research effort would be used to advance our understanding of biology and disease and to improve health. In the years since the HGP's completion there has been much excitement about the potential for so-called 'personalized medicine' to reach the clinic. More recently, a report from the National Academy of Sciences [dels.nas.edu] has called for the adoption of 'precision medicine,' where genomics, epigenomics, environmental exposure, and other data would be used to more accurately guide individual diagnosis [nimh.nih.gov]. Genomic medicine, as defined above, can be considered a subset of precision medicine.

The translation of new discoveries to use in patient care takes many years. Based on discoveries over the past five to ten years, genomic medicine is beginning to fuel new approaches in certain medical specialties. Oncology, in particular, is at the leading edge of incorporating genomics, as diagnostics for genetic and genomic markers are increasingly included in cancer screening, and to guide tailored treatment strategies.

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It has often been estimated that it takes, on average, 17 years to translate a novel research finding into routine clinical practice. This time lag is due to a combination of factors, including the need to validate research findings, the fact that clinical trials are complex and take time to conduct and then analyze, and because disseminating information and educating healthcare workers about a new advance is not an overnight process.

Once sufficient evidence has been generated to demonstrate a benefit to patients, or "clinical utility," professional societies and clinical standards groups will use that evidence to determine whether to incorporate the new test into clinical practice guidelines. This determination will also factor in any potential ethical and legal issues, as well economic factors such as cost-benefit ratios.

The NHGRI Genomic Medicine Working Group (GMWG) has been gathering expert stakeholders in a series of Genomic Medicine meetings to discuss issues surrounding the adoption of genomic medicine. Particularly, the GMWG draws expertise from researchers at the cutting edge of this new medical specialty, with the aim of better informing future translational research at NHGRI. Additionally the working group provides guidance to the National Advisory Council on Human Genome Research (NACHGR) and NHGRI in other areas of genomic medicine implementation, such as outlining infrastructural needs for adoption of genomic medicine, identifying related efforts for future collaborations, and reviewing progress overall in genomic medicine implementation.

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For more examples of genomic medicine advances, please see Notable Accomplishments in Genomic Medicine

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At NHGRI, the Division of Genomic Medicine administers research programs with a clinical focus. A number of research programs currently underway are generating the evidence base, and designing and testing the implementation of genome sequencing as part of an individual's clinical care:

Within NHGRI's Division of Policy, Communications, and Education, the Policy and Program Analysis Branch (PPAB), and the Genomic Healthcare Branch (GHB) are both involved in helping pave the way for the widespread adoption of genomic medicine.

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Last Updated: March 31, 2015

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Genomic Medicine - Genome.gov

Back to TopTreatment

The goal of treatment is to reduce pain, improve function, and prevent further joint damage. The underlying cause often cannot be cured.

LIFESTYLE CHANGES

Lifestyle changes are the preferred treatment for osteoarthritis and other types of joint swelling. Exercise can help relieve stiffness, reduce pain and fatigue, and improve muscle and bone strength. Your health care team can help you design an exercise program that is best for you.

Exercise programs may include:

Your health care provider may suggest physical therapy. This might include:

Other things you can do include:

MEDICINESS

Medicines may be prescribed along with lifestyle changes. All medicines have some risks. You should be closely followed by a doctor when taking arthritis medicines.

Over-the-counter medicines:

Prescription medicines:

It is very important to take your medicines as directed by your doctor. If you are having problems doing so (for example, because of side effects), you should talk to your doctor. Also make sure your doctor knows about all the medicines you are taking, including vitamins and supplements bought without a prescription.

SURGERY AND OTHER TREATMENTS

In some cases, surgery may be done if other treatments have not worked. This may include:

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Arthritis - Symptoms, Diagnosis, Treatment of Arthritis - NY ...

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DENVER -- Stem cell therapy soon might become the go-to treatment option for patients with osteoarthritis or chronic injury. But is the treatment for everybody?

It was the answer for former Broncos player Mark Schlereth, who dealt with daily pain.

I call it a varying degree of crappiness of how I feel," Schlereth said.

Schlereth played guard in the NFL for 12 seasons, and aches and pain were considered the daily norm for him.

You have to understand when you play that game you live with a certain amount of pain your entire adult life," he said.

He has the broken helmet he played with to prove it.

This was a helmet that I actually broke; I cracked it in a game," Schlereth said.

All the hits, blocks and big games came with a price, according to Schlereth.

Twenty knee surgeries, a bunch of elbow surgeries, it's back surgeries, kidney surgery, 29 combined surgeries," he said.

It wasnt until recently that the three-time Super Bowl champion found stem cell therapy, a treatment many in the medical community are hailing as a miracle.

Its amazing what a difference its made, he said.

Dr. Michael Cantor injected both of Schlereths shoulders with a combination of the former football player's own plasma, platelets and stem cells.

These platelets will then send a signal out to the bone marrow to send in the stem cells and once they arrive in the bloodstream at the site, the platelets drive the reaction and say, stem cells lay down new cartilage, new bone, new ligament," Cantor said.

Dr. Joel Cherdack of Denver Regenerative Medicine says its like hitting the reset button.

Weve been able to have them walking around pain free within four weeks," he said.

It promotes a process of healing in the body, giving it a second chance.

Youll wake up one morning and go, 'Wow, I was in a position sleeping that I couldnt have slept six weeks ago,' Schlereth said.

This is where the unthinkable is now becoming a reality.

I think its going to be a revolution in orthopedics, said Dr. Cecilla Pascual-Garrido, the leading researcher on stem cell therapy at University of Colorado Hospital.

But she did say this treatment isnt for everyone.

The time that we have to treat these patients is the time between when they were active and happy and between when they really need a hip replacement," Pascual-Garrido said.

Pat Lynch was a lifelong runner, and years of pounding the streets and mountain trails left him with daily hip and back pain. The pain has been so debilitating that it takes away from everyday things, including his job.

Lynch decided to look into stem cell treatments, so he sought out Pascual-Garrido, who told him he was too far gone, saying it would not be appropriate in his case to do stem cells.

The key is to have a patient with early osteoarthritis. If you have a patient with advanced osteoarthritis, the therapy will not work, Pascual-Garrido said.

Lynchs hip is nearly bone on bone; Pascual-Garrido said the stem cell cant regenerate tissue or cartilage that isnt there.

Its still research and we will have many years ahead to understand and see which patient is going to be beneficial from this treatment," she said.

Lynch is left with the option of living in pain or having a hip replacement.

Im not particularly fond of taking a chunk of my body out and replacing it with steel. I would rather do stem cells," he said.

In the Schlereth household, Mark is not the only one who has received this stem cell treatment. His Major League Baseball playing son Daniel has also undergone the treatment.

Mark Schlereth said hes looking forward to getting the therapy everywhere it hurts.

You know, Im going to be like the bionic man by the time its all said and done. Its just going to take a little time," he said.

It can cost anywhere from $1,200 to $8,000 a treatment.

Stem cell is not covered by insurance, but doctors said this is the future of medicine.

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Stem cell therapy relieves aches and pains; described as ...

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International stem cell clinics advertise curesfor a price. Understand the concerns over stem cell tourism and what CIRM is doing to bring real cures to patients who need them.

International (and even domestic) clinics have begun advertising unproven therapies at great cost to the patient and at great profit to the clinicthis is whats referred to as stem cell tourism. But a closer look will often reveal no information about what type of stem cells are being offered. These sites also rely heavily on video testimonials from people soon after the stem cell injections, but little information about how those people fared long-term.

At the 2010, meeting of the International Society for Stem Cell Research in San Francisco, CIRM co-hosted a panel in which the worlds top experts discussed the steps leading to a stem cell therapy, and concerns about stem cell tourism.

At that panel, the ISSCR previewed their new web site designed to help patients and their families assess international clinics advertising stem cell cures.

CIRM is also one of 13 organizations who issued a joint advisory on stem cell tourism, which addresses questions about how to identify regulated stem cell clinical trials. You can read that advisory here.

Find out More: A Dose of Reality on Alternative Stem Cell Treatments (video) ISSCR: A closer look at stem cell treatments The Power of Stem Cells

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Stem Cell Tourism | California's Stem Cell Agency

Every day we get a call from someone seeking help. Some are battling a life-threatening or life-changing disease. Others call on behalf of a friend or loved one. All are looking for the same thing; a treatment, better still a cure, to ease their suffering.

Almost every day we have to tell them the same thing; that the science is advancing but its not there yet. You can almost feel the disappointment, the sense of despair, on the other end of the line.

If its hard for us to share that news, imagine how much harder it is for them to hear it. Usually by the time they call us they have exhausted all the conventional therapies. In some cases they are not just running out of options, they are also running out of time.

Chasing hope

Sometimes people mention that they went to the website of a clinic that was offering treatments for their condition, claiming they had successfully treated people with that disease or disorder. This week I had three people mention the same clinic, here in the US, that was offering them treatments for multiple sclerosis, traumatic brain injury and chronic obstructive pulmonary disease (COPD). Three very different problems, but the same approach was used for each one.

Its easy to see why people would be persuaded that clinics like this could help them. Their websites are slick and well produced. They promise to take excellent care of patients, often helping take care of travel plans and accommodation.

Theres just one problem. They never offer any scientific evidence on their website that the treatments they offer work. They have testimonials, quotes from happy, satisfied patients, but no clinical studies, no results from FDA-approved clinical trials. In fact, if you explore their sites youll usually find an FAQ section that says something to the effect of they are not offering stem cell therapy as a cure for any condition, disease, or injury. No statements or implied treatments on this website have been evaluated or approved by the FDA. This website contains no medical advice.

What a damning but revealing phrase that is.

Now, it may be that the therapies they are offering wont physically endanger patients though without a clinical trial its impossible to know that but they can harm in other ways. Financially it can make a huge dent in someones wallet with many treatments costing $10,000 or more. And there is also the emotional impact of giving someone false hope, knowing that there was little, if any, chance the treatment would work.

Shining a light in shady areas

U.C. Davis stem cell researcher, CIRM grantee, and avid blogger Paul Knoepfler, highlighted this in a recent post for his blog The Niche when he wrote:

Paul Knoepfler

Patients are increasingly being used as guinea pigs in the stem cell for-profit clinic world via what I call stem cell shot-in-the-dark procedures. The clinics have no logical basis for claiming that these treatments work and are safe.

As the number of stem cell clinics continues to grow in the US and morephysicians add on unproven stem cell injections into their practices as a la carte options, far more patients are being subjected to risky, even reckless physician conduct.

As if to prove how real the problem is, within hours of posting that blog Paul posted another one, this time highlighting how the FDA had sent a Warning Letter to the Irvine Stem Cell Treatment Center saying it had serious concerns about the way it operates and the treatments it offers.

Paul has written about these practices many times in the past, sometimes incurring the wrath of the clinic owners (and very pointed letters from their lawyers). Its to his credit that he refuses to be intimidated and keeps highlighting the potential risks that unapproved therapies pose to patients.

Making progress

As stem cell science advances we are now able to tell some patients that yes, there are promising therapies, based on good scientific research, that are being tested in clinical trials.

There are not as many as we would like and none have yet been approved by the FDA for wider use. But those will come in time.

For now we have to continue to work hard to raise awareness about the need for solid scientific evidence before more people risk undergoing an unproven stem cell therapy.

And we have to continue taking calls from people desperate for help, and tell them they have to be patient, just a little longer.

***

If you are considering a stem cell treatment, the International Society for Stem Cell Research had a terrific online resource, A Closer Look at Stem Cells. In particular, check out the Nine Things to Know about Stem Cell Treatments page.

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Guest Author Geoff Lomax is CIRMs Senior Officer for Medical and Ethical Standards.

In the spirit of Stem Cell Awareness Day, Cell Stem Cell has compiled a Public Interest collection of articles covering ethical, legal, and social implications of stem cell research and made it freely available. The collection may be found here.

The collection covers issues ranging from research involving human embryos to the use of stem cell therapies in patients. For those of you interested in a good primer on the history of stem cell controversies, Herbert Gottweis provides a detailed review of the federal policy debate in the United States. This debate has resulted in inconsistent policy and disrupted research. Gottweis uses this history to support his message that a comprehensive, and proactive policy approach in this field beyond the quick legal fix is needed for patients to ultimately benefit from the science.

What I found most interesting about this collection was the focus on stem cell treatments and tourism. A majority of the articles address the use of stem cells in patients. This focus is an indicator of how far the field has progressed. Stem cells clinical trials are now a reality and this results in two separated but related considerations. First, is how to make sure prospective patients are well informed should they participate in a clinical trial. Second, how to avoid stem cell snake oil where someone is pitching an unproven procedure. These issues are related by their solution that involves empowerment and education of patients and their support networks.

For example, in Stem Cell Tourism and Public Education: The Missing Elements, Master writes:

It is important for the scientific, medical, ethics, and policy communities to continue to promote accurate patient and public information on stem cell research and tourism and to ensure that it is effectively disseminated to patients by working alongside patient advocacy groups.

Masters team found that groups committed to the advancement of good science, including patient advocates and researchers, often lacked basic information about clinical trials and other options for patients. This lack of information may contribute to patients being wooed by those pitching unproven procedures. Thus, the research community should continue to work with patients and advocacy organizations to identity options for treatment.

Another aspect of patient empowerment is what Insoo Huyn refers to as therapeutic hope in his piece: Therapeutic Hope, Spiritual Distress, and the Problem of Stem Cell Tourism. Huyn suggests that a supportive system for delivering cell therapies should includes nurturing hope. He writes, patients might understand when an interventions chances of success are extremely remote at best, but may still want to give it a shot as long as a beneficial outcome cannot be ruled out as categorically impossible. Huyn recognizes that well developed early-stage clinical trials are not expected to provide a benefit to patients (they are designed to evaluate safety), but the nature of the therapeutic (often cells) means there may be some real effect.

A third piece by the ISSCR Ethics Taskforce titled Patients Beware: Commercialized Stem Cell Treatments on the Web presents a guide to evaluating therapies. They present five principles that patients, researchers and advocates can rally around to identify credible interventions. The taskforce states:

The guiding principles for the development of the recommended process were that (1) the standards for identifying and reviewing clinics and suppliers should be objective and clear; (2) the inquiry and review process should be publicly transparent and relatively straight- forward for any clinic or practitioner to comply with; (3) conflicts of interest, if any, of the declarant ought to be disclosed to the ISSCR; (4) there should be no actual or apparent conflicts of interest of staff or others involved in the inquiry or review process for any particular matter; and (5) any findings that a clinic fails to meet standards should be communicated in a specific factual way, rather than with broad conclusions of fraudulent practices.

While the Cell Stem Cell Public Interest series covers a range of issues related to stem cells and society, the emphasis on treatments and patients is a reminder of how far the field has come. There is broad consensus that patients, researchers and advocates have roles to play in advancing safe and effective cell therapies.

Geoff Lomax

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Here are some stem cell stories that caught our eye this past week. Some are groundbreaking science, others are of personal interest to us, and still others are just fun.

The zebrafish (Danio rerio) owes its name to a repeating pattern of blue stripes alternating with golden stripes. [Credit: MPI f. Developmental Biology/ P. Malhawar]

How the Zebrafish Got its Stripes. Scientists in Germany have identified the different pigment cells that emerge during embryonic development and that determine the signature-striped pattern on the skins of zebrafishone of sciences most commonly studied model organisms. These results, published this week in the journal Science, will help researchers understand how patterns, from stripes to spots to everything in between, develop.

In the study, scientists at the Max Planck Institute for Developmental Biology mapped how three distinct pigment cells, called black cells, reflective silvery cells, and yellow cells emerge during development and arrange themselves into the characteristic stripes. While researchers knew these three cell types were involved in stripe formation, what they discovered here was that these cells form when the zebrafish is a mere embryo.

We were surprised to observe such cell behaviors, as these were totally unexpected from what we knew about color pattern formation, says Prateek Mahalwar, first author of the study, in a news release.

What most surprised the research team, according to the news release, was that the three cell types each travel across the embryo to form the skin from a different direction. According to Dr. Christiane Nsslein-Volhard, the studys senior author:

These findings inform our way of thinking about color pattern formation in other fish, but also in animals which are not accessible to direct observation during development such as peacocks, tigers and zebras.

Sound Waves Dispense Individual Stem Cells. It happens all the time in the lab: scientists need to isolate and study a single stem cell. The trick is, how best to do it. Many methods have been developed to achieve this goal, but now scientists at the Regenerative Medicine Institute (REMEDI) at NUI Galway and Irish start-up Poly-Pico Technologies Ltd. have pioneered the idea of using sound waves to isolate living stem cells, in this case from bone marrow, with what they call the Poly-Pico micro-drop dispensing device.

Poly-Pico Technologies Ltd., a start-up that was spun out from the University of Limerick in Ireland, has developed a device that uses sound energy to accurately dispense protein, antibodies and DNA at very low volumes. In this study, REMEDI scientists harnessed this same technology to dispense stem cells.

These results, while preliminary, could help improve our understanding of stem cell biology, as well as a number of additional applications. As Poly-Pico CEO Alan Crean commented in a news release:

We are delighted to see this new technology opportunity emerge at the interface between biology and engineering. There are other exciting applications of Poly-Picos unique technology in, for example, drug screening and DNA amplification. Our objective here is to make our technology available to companies, and researchers, and add value to what they are doing. This is one example of such a success.

The Dangers of Stem Cell Toursim. Finally, a story from ABC News Australia, in which they recount a womans terrifying encounter with an unproven stem cell technique.

In this story, Annie Levington, who has suffered from multiple scleoris (MS) since 2007, tells of her journey from Melbourne to Germany. She describes a frightening experience in which she paid $15,000 to have a stem cell transplant. But when she returned home to Australia, she saw no improvement in her MSa neuroinflammatory disease that causes nerve cells to whither.

They said I would feel the effects within the next three weeks to a year. And nothing I had noticed nothing whatsoever. [My neurologist] sent me to a hematologist who checked my bloods and concluded there was no evidence whatsoever that I received a stem cell transplant.

Sadly, Levingtons story is not unusual, though it is not as dreadful as other instances, in which patients have traveled thousands of miles to have treatments that not only dont cure they conditionthey actually cause deadly harm.

The reason that these unproven techniques are even being administered is based on a medical loophole that allows doctors to treat patients, both in Australia and overseas, with their own stem cellseven if that treatment is unsafe or unproven.

And while there have been some extreme cases of death or severe injury because of these treatments, experts warn that the most likely outcome of these untested treatments is similar to Levingtonsyour health wont improve, but your bank account will have dwindled.

Want to learn more about the dangers of stem cell tourism? Check out our Stem Cell Tourism Fact Sheet.

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One of the big concerns among scientists including many at the International Society for Stem Cell Research (ISSCR) conference in Vancouver, Canada is that patient expectations about stem cells are often greater than researchers are able to deliver today. That can result in patients in search of a cure heading to overseas clinics that offer unproven therapies.

Megan Munsie head of the Education, Ethics, Law and Community Awareness Unit at the University of Melbourne in Australia wanted to find out what happens when patients hopes for new treatments come into conflict with scientific views on medical evidence. So she started with a small survey of 16 Australians, patients and patient-caretakers, who had travelled outside Australia for stem cell treatments for a variety of diseases including MS and cerebral palsy.

She says there were a number of interesting findings:

Perhaps the most surprising finding was that all of them talked about the benefits they gained from going abroad for the treatment, that it gave them a sense of hope even if there was no evidence of medical benefit.

What happens when patients hopes for new treatments come into conflict with scientific views on medical evidence?

This led to a bigger study where Munsie surveyed patients and patient advocates but also stem cell scientists and physicians. Not surprisingly the researchers had a very different view of the subject than the patients.

Researchers/doctors said they felt that patients dont understand science and dont appreciate the subtleties of clinical trials

What was interesting, however, is that many doctors said they didnt try to persuade their patients not to go, instead they chose to respect their autonomy but did at least try to give them the facts so that they could make a decision based on knowledge not ignorance.

When asked why they didnt tell patients not to go, they said they respected the patients need for hope and didnt want to take that away from them because they had nothing they could offer to replace it.

Munsie says recently some doctors have started offering these kinds of unproven therapies in Australia. She talked to four of them asking how they could justify it. All four said there is a huge unmet medical need and it was better to offer these therapies in Australia than have patients travel to other countries for them. They also said that they felt competent to provide treatment because they had undergone some kind of training or had a license to use equipment needed for the therapy.

Ironically while they all considered themselves legitimate providers of a needed medical therapy albeit an unproven one and only interested in the science, they regarded others doing the same as cowboys and only interested in the money.

When asked if they would support more regulation of the kinds of therapies they were already offering they said yes, saying that the other doctors who claimed they were self-regulating is like giving the keys to the asylum to the lunatics.

Munsie says its clear that its not just patients who could benefit from some guidance on expectations about stem cell therapies.

She says we need to do a better job of managing patient expectations without robbing them of a sense of hope, perhaps by offering them information that is more tailored to their particular needs.

We also need to manage what she called the unbridled enthusiasm of providers who are offering speculative treatments as medical practice. That might take regulatory change by the government.

She says its difficult to strike a balance between hope and scientific evidence, in maintaining a patients sense of optimism while acknowledging the reality of the science and the risks posed by unproven treatments.

Kevin McCormack

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One of the big concerns among scientists including many at the International Society for Stem Cell Research (ISSCR) conference in Vancouver, Canada is that patient expectations about stem cells are often greater than researchers are able to deliver today. That can result in patients in search of a cure heading to overseas clinics that offer unproven therapies.

Megan Munsie head of the Education, Ethics, Law and Community Awareness Unit at the University of Melbourne in Australia wanted to find out what happens when patients hopes for new treatments come into conflict with scientific views on medical evidence. So she started with a small survey of 16 Australians, patients and patient-caretakers, who had travelled outside Australia for stem cell treatments for a variety of diseases including MS and cerebral palsy.

She says there were a number of interesting findings:

Perhaps the most surprising finding was that all of them talked about the benefits they gained from going abroad for the treatment, that it gave them a sense of hope even if there was no evidence of medical benefit.

What happens when patients hopes for new treatments come into conflict with scientific views on medical evidence?

This led to a bigger study where Munsie surveyed patients and patient advocates but also stem cell scientists and physicians. Not surprisingly the researchers had a very different view of the subject than the patients.

Researchers/doctors said they felt that patients dont understand science and dont appreciate the subtleties of clinical trials

What was interesting, however, is that many doctors said they didnt try to persuade their patients not to go, instead they chose to respect their autonomy but did at least try to give them the facts so that they could make a decision based on knowledge not ignorance.

When asked why they didnt tell patients not to go, they said they respected the patients need for hope and didnt want to take that away from them because they had nothing they could offer to replace it.

Munsie says recently some doctors have started offering these kinds of unproven therapies in Australia. She talked to four of them asking how they could justify it. All four said there is a huge unmet medical need and it was better to offer these therapies in Australia than have patients travel to other countries for them. They also said that they felt competent to provide treatment because they had undergone some kind of training or had a license to use equipment needed for the therapy.

Ironically while they all considered themselves legitimate providers of a needed medical therapy albeit an unproven one and only interested in the science, they regarded others doing the same as cowboys and only interested in the money.

When asked if they would support more regulation of the kinds of therapies they were already offering they said yes, saying that the other doctors who claimed they were self-regulating is like giving the keys to the asylum to the lunatics.

Munsie says its clear that its not just patients who could benefit from some guidance on expectations about stem cell therapies.

She says we need to do a better job of managing patient expectations without robbing them of a sense of hope, perhaps by offering them information that is more tailored to their particular needs.

We also need to manage what she called the unbridled enthusiasm of providers who are offering speculative treatments as medical practice. That might take regulatory change by the government.

She says its difficult to strike a balance between hope and scientific evidence, in maintaining a patients sense of optimism while acknowledging the reality of the science and the risks posed by unproven treatments.

Kevin McCormack

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stem cell tourism | The Stem Cellar

Autism Treatment

Current investigative therapies for autism attempt to reverse these abnormalities through administration of antibiotics, antiinflammatory agents, and hyperbaric oxygen. Unfortunately, none of these approaches address the root causes of oxygen deprivation and intestinal inflammation.

Mesenchymal stem cells can regulate the immune system. It is thought that they may help to reverse inflammatory conditions and is currently in the final stages of clinical trials in the US for Crohns disease, a condition resembling the gut inflammation in autistic children.

Through administration of mesenchymal stem cells, we have observed improvement in patients treated at our facilities. The biological basis for our scientists in the peer published treatment method reviewed in the Journal of Translational Medicine: Stem Cell Therapy for Autism.

The adult stem cells used to treat autism at the Stem Cell Institute come from human umbilical cord tissue (allogeneic mesenchymal). Umbilical cords are donated by mothers after normal, healthy births. Before they are approved for treatment all umbilical cord-derived stem cells are screened for viruses and bacteria to International Blood Bank Standards. In some cases, we also utilize stem cells harvested from the patients own bone marrow. Umbilical cord-derived stem cells are ideal for the treatment of autism because they allow our physicians to administer uniform doses and they do not require any stem cell collection from the patient, which for autistic children and their parents, can be an arduous process. Because they are collected right after (normal) birth, umbilical cord-derived cells are much more potent than their older counterparts like bone marrow-derived cells for instance. Cord tissue-derived mesenchymal stem cells pose no rejection risk because the body does not recognize them as foreign.

Because HUCT stem cells are less mature than other cells, the bodys immune system is unable to recognize them as foreign and therefore they are not rejected. Weve treated hundreds of patients with umbilical cord stem cells and there has never been a single instance rejection (graft vs. host disease). HUCT stem cells also proliferate/differentiate more efficiently than older cells, such as those found in the bone marrow and therefore, they are considered to be more potent.

Through retrospective analysis of our cases, weve identified proteins and genes that allow us to screen several hundred umbilical cord donations to find the ones that we know are most effective. We only use these cells and we call them golden cells.

We go through a very high throughput screening process to find cells that we know have the best anti-inflammatory activity, the best immune modulating capacity, and the best ability to stimulate regeneration.

The umbilical cord-derived stem cells are administered intravenously by a licensed physician.

*NOTE Treatment protocol will be assigned by staff physicians after the patient has submitted all requested medical information and received approval. A patients recommended protocol may differ from the example given below.

Below is an example of a typical autism protocol:

Proper follow-up is an essential part of the autism treatment process. Our primary goal is to ensure that your child is progressing safely. Regular follow-up also enables us to evaluate efficacy and improve our autism treatment protocols based on observed outcomes.

Therefore, our medical staff will be contacting you after 1 month, 3 months, 4 months, and 1 year to monitor your childs progress.

Yes, you may. Once your child has been evaluated and approved for treatment by our medical team, your patient coordinator will be happy to put you in touch with a few.

We also welcome you to view testimonials, news articles and videos from treated cerebral palsy. Please take a look!

You may contact us by telephone 1 (800) 980-STEM (toll-free in US) and 1 (954) 358-3382.

To apply for stem cell treatment, please complete this Patient Application Form.

Stem Cell Therapy for Autism Ichim T, Solano F, Glenn E, Morales F, Smith L, Zabrecky G, Riordan Neil. Journal of Translational Medicine 2007, 5:30

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Stem Cell Therapy for Autism - Medical Information - Panama Ci

Why Spray Supplements Work Best Monday, July 20th, 2015

On a regular basis we are asked why is it best we take the supplementintraorally (sprayed under the tongue)?

We reply: because this enables almost all of the nutrients to hit the bloodstream quickly, which is extremely effective. The absorption rate for an intraoral spray delivery (referred to as sublingual in certain contexts) enables up to 95% of the nutrients to be absorbed into the bloodstream, whereas pills and capsules have an absorption rate of only 10% to 20% at best.

So Why Is This?

When certain molecules are placed under the tongue, they are absorbed through the sub-mucosal membrane (a layer of connective tissue that sits beneath your tongue), that has a direct route into the bloodstream. This enables almost all of the nutrients to get into the bloodstream in their entirety and get to work straight away. There are no road blocks, no waiting just straight into the bloodstream (the bodys principal carrier of nutrients throughout the entire body) and off to work they go.

So What About When You Swallow a Pill or Capsule?

Good question. When you swallow a pill or capsule it must go through your entire gastrointestinal tract. This means the stomach (which has acid and bile), and the intestines (where most of the absorption takes place), and then off to the liver, where more filtering is done. THEN finally what is left of the nutrients is delivered to where it is needed. If you have a healthy gastrointestinal tract, healthy stomach and liver, the absorption rate of nutrients that finally get into your bloodstream and the intended destination point will be 20%. The problem is over 70% of the American population suffer from digestive and/or gastrointestinal tract issues. This results in very poor absorption through the intestines and liver (i.e. leaky gut syndrome is common), and these issues reduce the absorption rate when taking a pill or capsule to less than 10%.

Speed is also an important factor. Not only is the absorption rate of nutrients far superior with intraoral delivery, the speed via this route is fast and direct, and because the potency of the formulation stays intact, less nutrients are needed making this delivery very cost effective.

The digestive tract is one incredibly harsh route and it is set up this way for a purpose. It is how our food is broken down. The nutrients get stripped out, the waste gets filtered. This is why pills are getting so large, as many companies try to squeeze more nutrients into them. Many people cut a pill or capsule in half and then put the contents under the tongue, but the problem is often the compressed manufacturing processes of a pill have already destroyed many of its nutrients. Another big negative with a pill and capsule is its coating and fillers.

Coatings and fillers are used in most pills and capsules to bind the ingredients together, fill and/or lubricate the contents, and accelerate manufacturing through the equipment so they dont stick together. This is not the case for liquid health supplements. Fillers and binders are not nearly so common in liquid supplements because they are not needed.

Pills and capsules generally contain a lot more low grade ingredients than liquid supplements.

Never buy proprietary blends. Most proprietary blends contain a bunch of low grade ingredients that are grouped together so you dont have a clue of the purity or source of each ingredient. Always look on the label for the individual ingredients to be noted separately with their actual percentage of purity displayed.

Yes, quality supplements are more expensive, but when the ingredients are stated individually on the label, with a high percentage of purity noted, you are receiving quality. Also look for the ingredients to be stated in milligrams (mgs) or grams. Mcgs (watch for that little c) and IUs equate to zilch. If you see IUs, Mcgs or Ng measurements, do the math using an online conversion calculator.

Liquid intraoral / sublingual formulations are the way of the future. You want to ensure you spray the formulation under your tongue, hold for at least 7 seconds, then swallow the remainder of the formulation. If you look around in the Health Stores today, you will find a good range of liquid and spray health supplements but ensure when taking any liquid supplement you dont just chug-a-lug it downso it all runs down your throat. The spray under the tongue method is by far the best delivery method for health supplements as stated in the Physicians Desk Reference. Pharmaceutical companies are moving quickly to develop many sublingual and intraoral applications (including diabetic medications).

For more information on intraoral health supplements click here: http://www.stemcellworx.com

Tags: best health supplements, best stem cell supplement, stem cell supplement Posted in best health supplements, best stem cell supplement, look for with health supplements, stem cell nutrition, stem cell supplement, Stem Cell Worx | Comments Off on Why Spray Supplements Work Best

Doctors and Scientists all around the world acknowledge a persons own adult stem cells have the ability to provide remarkable repair, renewal and anti-aging abilities throughout a persons entire life time.In the last decade, more recent research shows we can treat, heal and repair our existing organs, blood, cartilage, muscle and tissue with our own stem cells.

As reported in the Health Digest you can do this by:

Here are ways stem cell activation can be done.

A) Some people undergo full stem cell replacement therapy (in a medical setting) where a persons own stem cells or those from a donor are drawn from the blood. The blood is then put into a centrifuge to spin down and separate out the stem cells so they become very concentrated. They are then put back into the body (by injection / intravenous administration) where the stem cells are precisely directed into the actual site of injury or damage where the repair and renewal is needed. This is a very effective form of treatment however it can be very expensive. For this treatment the stem cells are mostly taken from the bone marrow, blood or skin. When a persons own stem cells arent able to be used, they can be obtained from a donor (often the case for those suffering from a life threatening disease).

B) Take a powerful stem cell supplement.

Stem Cell Worx Intraoral Spray is the most powerful stem cell supplement in the market due to:

C) Other methods that have been found to have some stem cell stimulating properties include:

Just as healthy lifestyle choices have the ability to help maintain and trigger your healthy stem cells, Scientists also report that negative lifestyle habits have the opposite effect and can greatly suppress your bodys ability to produce and release stem cells.Negative effects include cigarette smoking, lack of sleep, stress, emotional extremes, a lazy lifestyle and poor nutrition.

As we age, our own adult stem cells diminish in quality and quantity. It is now possible to stimulate, increase and trigger your adult stem cells with Stem Cell Worx Intraoral Spray (sprayed under the tongue enabling maximum absorption of nutrients for natural stem cell stimulation).

Tags: Activate Stem Cells, stem cell supplement, stimulate stem cells Posted in activate own stem cells, best stem cell supplement, Stem Cell Worx, stimulate stem cells | Comments Off on How To Stimulate Your Own Stem Cells

As we age:

Stem Cell Worx Is At The Forefront of Nutritional Supplementation

Stem Cell Worx Intraoral Spray is a natural dietary health supplement that activates your own adult stem cells naturally and provides robust immunity. With 50 to 70 trillion cells in our body, cellular health is crucial to our overall well-being and good health. Adult stem cells working at optimal levels provide the platform for many cumulative health benefits. Stem Cell Worx is the most powerful stem cell supplement on the market. It is taken sublingually (sprayed under the tongue) enabling 95% of its nutrients to be absorbed quickly into the bloodstream compared to the 10% to 20% absorption rate that pills and capsules only provide. Stem Cell Worxs pure ingredients provide the highest grade of natural growth and immune factors available. Growth and immune factors are vital in the initiation process as they have the ability to bind with the adult stem cells in order to activate them.

Stem Cell Worx Intraoral Spray targets anti-oxidant optimization, adult stem cell activation and provides advanced immune response, cellular repair and renewal. Clinical studies and research back up this new wave of nutrition.

Stem Cell Worx Intraoral Sprayis a leader in the field of nutritional supplementation providing many benefits including:

For further information visit: http://www.stemcellworx.com

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Here Doctor Daniel Pompa from Park City, Utah talks about how you must fix the cell in order to get well.

In this short video he provides an overview of why the cells in our body are being damaged, and why so many diseases and disorders are on the increase.

Stem Cell Worx Intraoral Spray is a natural dietary health supplement designed specifically to improve and activate ones own adult stem cells (the repair and renewal cells of the entire body). Manufactured by a specialized Laboratory in the U.S.A. it is one of the only stem cell supplements on the market that contains abundant natural growth and immune factors, that are absolutely necessary to bind with adult stem cells in order to active them. It is the only stem cell supplement delivered in intraoral spray format (spray under the tongue, hold then swallow), providing an absorption rate of up to 95% of its nutrients.

Tags: cell supplement, cellular health, fix the cell you'll get well, stem cell supplement Posted in activate stem cells, cell health, fix the cell, stem cell nutrition, stem cell supplement, stem cell supplements, stem cell therapy, Stem Cell Worx | Comments Off on Fix The Cell And Youll Get Well with Stem Cell Worx

T cells are a type of blood cell that protect the body from infection.

All T cells originate fromhaematopoietic stem cells (a type of adult stem cell) locatedin thebone marrow. There are certain sub-populations of T cells (that include a number of the CD+ cells). See more about adult stem cells below.

The thymus is a specialized organ of the immune system and contributes fewer cells as a person ages. This is because thethymus shrinks by about 3%a year throughout middle age, resulting in a corresponding fall in the thymic production ofnaive T cells.

A study published this week on May 15th 2013, by Immunity & Ageing, shows slower immune system aging in women than men.

Study Conclusion

The study (ref: doi: 10.1186/1742- 4933-10-19) concluded:

the rate of increase of these immunological parameters was greater in women than in men (p < 0.05). T cell proliferation index (TCPI) was calculated from the T cell proliferative activity and the number of T cells. It showed an age-related decline that was greater in men than in women (p < 0.05). The rate of decline in IL-6 and IL-10 production was also greater in men than in women (p < 0.05).

Age-related changes in various immunological parameters differ between men and woman. Our findings indicate that the slower rate of decline in these immunological parameters in women than that in men is consistent with the fact that women live longer than do men.

Recent research on adult stem cells has generated a great deal of excitement. Scientists now have technologies available to stimulate and replace these adult stem cells using a variety of stem cell therapies. Powerful adult stem cell supplements, such as Stem Cell Worx Intraoral Spray are also available. Stem Cell Worx Intraoral Spray has been scientifically proven to be one of the most powerful stem cell supplements on the market. Its pure, natural ingredients provide a triple effect of stem cell production from the bone marrow, enabling adult stem cells and their subsets CD+ cells, T cell and IL-6 proliferation to increase by as much as 50% within two weeks of taking the Stem Cell Worx Intraoral Spray supplement.

What are Adult Stem Cells?

The history of research on adult stem cells began more than 50 years ago. In the 1950s, researchers discovered that the bone marrow contains at least two kinds of stem cells. One population of adult stem cells is calledhaematopoietic stem cells, that form all the types of blood cells in the body. A second population, calledbone marrow stromal stem cells(also called mesenchymal stem cells, or skeletal stem cells by some), were discovered a few years later. With the latest advancements in the scientific and medical fields, especially in the last 5 years, its now possible to activate these adult stem cells through medical and specialized health supplement means.

An adult stem cell is an undifferentiatedcell. This means that under the right direction, adult stem cells can transform into a specific type of cell that promotes tissue, muscle, cartridge and organ repair and renewal.

The human bodys lymphatic system

References:

http://en.wikipedia.org/wiki/T_cell

Immunity & Ageing Research Paper: doi: 10.1186/1742-4933-10-19

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A natural activator of your own adult stem cells. Click here:

Stem Cell Supplement

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Dr. Edward D. Wagner is one of the most renowned Chiropractors and foremost holistic healers in the world.

Dr. Wagners healthcare career began over 35 years ago in one of the original health clubs in Southern California where he partnered with Jack La Lanne in the Jack La Lanne Nutrition Centers in Torrance and Rolling Hills, California.

In 1992 Dr. Wagner published Dr. Edward D. Wagners Complete Guide to Healing the Entire Body, Mind, and Spirit. Doctor Wagner has a Degree in Sports & Recreational Injuries; he is a licensed member of the American and Californian Chiropractic Associations; and Board Certified Fellow of the American Academy of Clinical Applied Spinal Biomechanical Engineering. He stops at nothing to restore a persons emotional, mental and physical well-being.

Today, Dr. Wagner practices from his California Office, Wagner Chiropractic situated in Sunset Blvd, Suite A230, Pacific Palisades, CA 90272, nestled between Malibu Beach and Santa Monica.

In this video, Dr. Wagner provides a review of a leading stem cell supplement called Stem Cell Worx Intraoral Spray. He explains why this natural health supplement is such an important requirement in todays world especially when the exposure to super bugs and nasty allergies is growing at an alarming rate, and younger people are more prone to illness than ever before. Good health starts at the cellular level and it is vital your immune system remains strong and robust throughout your entire lifetime. In this video, hear why Dr. Wagner puts this stem cell supplement, Stem Cell Worx Intraoral Spray at the forefront of nutritional supplementation.

Tags: Adult Stem Cell Supplement, nutritional health review, nutritional products review, stem cell supplement, Stem Cell Supplement Review, stem cell supplements Posted in activate stem cells, best supplement, best supplement review, cellular health, nutritional supplement, stem cell supplement, stem cell supplement review, stem cell supplements, Stem Cell Worx, top health supplement | Comments Off on Stem Cell Supplement Reviewed By World Renowned Chiropractor

First Responders recognize the potential and benefits of banking their own adult stem cells.

Watch the video below to see why First Responders are banking theirown adult stem cellsin preparedness should they be exposed to hazards as they may well require these life-savers at a later date.

Tags: Adult Stem Cell Supplement, Banking Stem Cells, stem cell supplement, stem cell supplements, Stem Cell Worx Posted in activate stem cells, adult stem cell supplement, stem cell supplement, stem cell supplements, Stem Cell Worx, Stem Cell Worx Intraoral Spray, stemcellworx | Comments Off on Benefits of Banking Own Adult Stem Cells

Pre-clinical research has generated very promising findings using adult stem cells from bone marrow for the treatment of diabetic wounds.

Research carried out by scientists at the National University of Ireland Galway is published in this months official journal of The American Diabetes Association. The work was led by researchers at the Universitys Regenerative Medicine Institute (REMEDI), which is supported by Science Foundation Ireland.

Tags: adult stem cell supplements, stem cell news, stem cell supplement, Stem Cell Worx, wound healing for diabetics Posted in activate stem cells, adult stem cells, bone marrow cells, bone marrow stem cells, cellular supplement, diabetic wound healing, stem cell diabetes, stem cell facts, stem cell news, stem cell supplement, stem cell supplements, Stem Cell Worx, Stem Cell Worx Intraoral Spray, stemcellworx, wound healing | Comments Off on Adult Stem Cells For Diabetic Wound Healing

Michael Phelan is the CEO ofSevOne. My Forbes colleagueTomio Geronrecentlywrote about his fast-growing IT company and Phelan contributed a guest post earlier this year atEric SavitzsCIO Network.

Phelan also has multiple sclerosis. Frustrated by the limited effectiveness of standard drugs for MS, he decided to try something more radical.

He traveled to a clinic in Panama and had infusions of adult stem cells generated from his own body fat.

It worked so well, hes going back for another treatment.

After mylast post, highlighting some research on the potential adverse consequences of adult stem cell treatments, some readers, including Phelan, protested that such studies represented but a small fraction of the thousands of successful treatments people were getting offshore, and that I was overlooking the patients perspective.

I asked if hed be interested in recounting his own story in more detail. Our Q&A was conducted by email.

Q: When did you first show symptoms of MS?

A: My symptoms started 7 years ago, in my late 40s. Im 56 now.

Q: Im assuming you began by seeking standard medical therapy. Can you tell me a bit about this, which drugs, and what led you gradually (or more speedily) to try a stem cell therapy?

A. I still use standard medical therapy. I have the best Neurologists in Philadelphia, at theUniversity of Pennsylvania Hospital, and Jefferson. I was on Copaxone for 5 years. Last month I started on Gilenya. Unfortunately, the approved, standard drug therapy has not been effective for me. I considered theTysabri (natalizumab)risks too high.

Q. Before going abroad, you attempted to get into some clinical trials here in the U.S. Can you tell me about the clinical trials you registered forand whether they explained why you did not qualify?

A. The first: Stem Cell Therapy for Patients With Multiple Sclerosis Failing Interferon A Randomized Study

The evaluation process is not funded; therefore I paid approximately $10,000 for travel to Chicago, for tests, MRIs, etc. The opinion of the investigators was the risk related to aggressive chemotherapy was not worth the potential gain because I was 55 years old, and the MRI evidence did not confirm enough recent disease activity. The treatment is most effective in active, early stages. My stage was questionable.

A second clinical trial:Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS. The research team is headed up by Jeffrey Cohen, MD, of the Cleveland Clinics Mellen Center for Multiple Sclerosis Treatment and Research. I did not qualify because I would be over 55 at the end point. This study is very similar to the treatment that I received in Panama.

Q. How did you come to learn about theStem Cell Institute in Panama?

A. I researched Pubmed, talked to physicians involved in U.S. studies and reviewed conference publications. I first learned about the Stem Cell Institute from Dr. Roger Nocera, author ofCells That Heal Us From Cradle To Grave.

I also noted that the Medical Director of the Stem Cell Institute was published:Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis.

Plus I read and viewed many personal testimonies of patients, such as famous Texas High School football coach,Sam Harrell.

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Stem Cell Supplement | Stem Cell Worx News

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Salt Lake researchers are launching a groundbreaking clinical trial to see if adult stem cell transplants will reverse or prevent kidney failure. If it works, it will be the kind of self-healing everybody has been waiting for. Stem cell transplants have proven successful in animal experiments in Germany and Salt Lake, but now the time has come to start clinical trials in humans. Two patients here have already had the stem cell transplants. Open heart surgery places a lot of stress on the kidneys, patients who have other complications often go into kidney failure. That's why this group has been selected for the clinical trial. A special kind of adult stem cell taken from the bone marrow of living donors will be injected into the blood stream shortly after their heart surgeries. Christof Westenfelder, M.D., the Chief Medical Officer at Allocure, said "These cells, after they read what's going on in the injured organ, then instruct the surviving cells in the injured organ to defend themse

Salt Lake researchers are launching a groundbreaking clinical trial to see if adult stem cell transplants will reverse or prevent kidney failure. If it works, it will be the kind of self-healing everybody has been waiting for. Stem cell transplants have proven successful in animal experiments in Germany and Salt Lake, but now the time has come to start clinical trials in humans. Two patients here have already had the stem cell transplants. Open heart surgery places a lot of stress on the kidneys, patients who have other complications often go into kidney failure. That's why this group has been selected for the clinical trial. A special kind of adult stem cell taken from the bone marrow of living donors will be injected into the blood stream shortly after their heart surgeries. Christof Westenfelder, M.D., the Chief Medical Officer at Allocure, said "These cells, after they read what's going on in the injured organ, then instruct the surviving cells in the injured organ to defend themselves, to repair the organ." The stem cells linger until the repair is complete, then, as programmed, self-destruct within three days so they won't go to other organs where they're not needed.

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Stem Cells to be Tested for Kidney Repair

CLINAM 9 / 2016 Conference and Exhibition

European & Global Summit for Cutting-Edge Medicine

June 26 29, 2016

Clinical Nanomedicine and Targeted Medicine

Enabling Technologies for Personalized Medicine

Conference Venue: Congress Center, Messeplatz 21, 4058 Basel, Switzerland, Phone +41 58 206 28 28, This email address is being protected from spambots. You need JavaScript enabled to view it. Organizers Office:CLINAMFoundation, Alemannengasse 12, P.B. 4016 Basel Phone +41 61 695 93 95, This email address is being protected from spambots. You need JavaScript enabled to view it.

Scientific Committee

Prof. Dr.med.PatrickHunziker, University Hospital Basel (CH) (Chairman)

Prof. Dr.med. ChristophAlexiou, UniversityHospitalErlangen(D)

Prof. Dr. Lajos Balogh, Editor-in-Chief Nanomedicine,Nanotechnology in Biology and Medicine, Elsevier and Member of the Executive Board, American Society for Nanomedicine, Boston (USA)

Prof. Dr. GerdBinnig, Nobel Laureate, Munich(D)

Prof. Dr. Yechezkel Barenholz, HebrewUniversity, Hadassah Medical School, Jerusalem(IL)

Prof. Dr. med. Omid Farokhzad, Associate Professor and Director of Laboratory of Nanomedicine and Biomaterials, Harvard Medical School and Brigham and Women's Hospital; Founder of BIND Therapeutics, Biosciences and Blend Therapeutics, Cambridge, Boston (USA)

Prof. Dr. med. Dong Soo Lee, PhD. Chairman Department of Nuclear Medicine Seoul National University Seoul, (KOR)

Dr. med. h.c. Beat Lffler, MA, European Foundation for Clinical Nanomedicine, Basel (CH)

Prof. Dr. Jan Mollenhauer, Lundbeckfonden Centerof Excellence NanoCAN, Universityof Southern Denmark, Odense (DK)

Prof. Dr. med. Marisa Papaluca Amati, European Medicines Agency, London (UK).

Prof. Dr. GertStorm, Institutefor Pharmaceutical Sciences, Utrecht University, (NL)

Prof. Dr. Viola Vogel, Laboratory for Biologically Oriented Materials, ETH, Zrich (CH)

In the previous eight years, the CLINAM Summit grew to the largest in its field with 12 presenting Noble Laureates and more than 500 participants from academia, industry, regulatory authorities and policy from over 40 different countries in Europe and worldwide. With this success and broad support by well beyond 20 renowned collaborating initiatives, the CLINAM-Summit is today one of the most important marketplaces for scientific exchange and discussions of regulatory, political and ethical aspects in this field of cutting-edge medicine.

In particular, the CLINAM Summit emerged as exquisite forum for translation from bench to bedside for European and international networking, for industrial collaboration between companies, with academia, and as point-of-contact with customers. The summit is presently the only place to meet the regulatory authorities from all continents to debate the needs of all stakeholders in the field with the legislators.

CLINAM 9/2016 continues with its successful tradition to cover the manifold interdisciplinary fields of Clinical and Targeted Nanomedicine in major and neglected diseases. As special focus area, CLINAM 09/2016 adds translation and enabling technologies, including, for example, cutting-edge molecular profiling, nano-scale analytics, single cell analysis, stem cell technologies, tissue engineering, in and ex vivo systems as well as in vitro substitute systems for efficacy and toxicity testing.

CLINAM 09/2016 covers the entire interdisciplinary spectrum of Nanomedicine and Targeted Medicine from new materials with potential medical applications and enabling technologies over diagnostic and therapeutic translation to clinical applications in infectious, inflammatory and neurodegenerative diseases, as well as diabetes, cancer and regenerative medicine to societal implications, strategical issues, and regulatory affairs. The conference is sub-divided into three different tracks running in parallel and provides ample possibilities for exhibitors as indicated by steadily increasing requests.

Track 1: Clinical and Targeted Nanomedicine Basic Research Disease Mechanisms and Personalized Medicine Regenerative Medicine Novel Therapeutic and Diagnostic Approaches Active and Passive Targeting Targeted Delivery (antibodies, affibodies, aptamers, and nano drug delivery devices) Accurin Technology Nano-Toxicology

Track 2: Clinical and Targeted Nanomedicine: Translation Unsolved Medical Problems Personalized Medicine and Theranostic Approaches Regenerative Medicine Advanced Breaking and Ongoing Clinical Trials Applied Nanomedical Diagnostics and Therapeutics

Track 3: Enabling Technologies Nanomaterial Analytics and Testing Molecular Profiling for Research and Efficacy/Toxicology Testing (Genomics, Proteomics, Glycomics, Lipidomics, Metabolomics) Functional Testing Assays and Platforms Single Cell Analyses Cell Tracking Stem Cell Biology and Engineering Technologies Microfluidics Tissue Engineering Tissues-on-a-Chip-Bioprinting In vivo Testing Novel Imaging Approaches Medical Devices

Track 4: Regulatory, Societal Affairs and Networking Regulatory Issues in Nanomedicine Strategy and Policy The Patients` Perspective Ethical Issues in Nanomedicine University Village Cutting-Edge EU-Project Presentations Networking for International Consortium Formation Regulatory Authorities Sessions

Based on last years exhibition it is expected to have about 30 Exhibitors at this Summit. Exhibitors can profit of the possibility to meet their target visitors on 1 single spot in Basel at CLINAM 9 / 2016. With its concept for the exhibition, the international CLINAM Summit becomes also the place for the pulse of the market and early sales in the field of cutting-edge medicine.

Deadline April 25, 2016 for oral Presentations Deadline for Poster Only Submission is May 15, 2016. Later submitted Posters can still be accepted but will not be included in the Summit-Proceedings. (See instruction in Folder on Page 25).

For full programme download the PDF Folder

Registration Fees (For Exhibition Pricing Look Folder, Page 25)

The European Foundation for Clinical Nanomedicine is a non-profit institution aiming at advancing medicine to the benefit of individuals and society through the application of nanoscience. Aiming at prevention, diagnosis, and therapy through nanomedicine as well as at exploration of its implications, the Foundation reaches its goals through support of clinically focussed research and of interaction and information flow between clinicians, researchers, the public, and other stakeholders. The recognition of the large future impact of nanoscience on medicine and the observed rapid advance of medical applications of nanoscience have been the main reasons for the creation of the Foundation.

Nanotechnology is generally considered as the key technology of the 21st century. It is an interdisciplinary scientific field focusing on methods, materials, and tools on the nanometer scale, i.e. one millionth of a millimeter. The application of this science to medicine seeks to benefit patients by providing prevention, early diagnosis, and effective treatment for prevalent, for disabling, and for currently incurable medical conditions.

Follow this link:
CLINAM - The Conference at a Glance

Many people are searching for something more they can do for their health in addition to standard medical treatment. At the Myrna Brind Center of Integrative Medicine at Jefferson in Philadelphia, we take personalized medicine to a new level. We care about your health and wellness goals, and it is our primary mission to help you achieve them.

Our physicians are guided by the science of medicine and are experts in the art of incorporating complementary and alternative medicine (CAM) therapies into the healing approach. This combined or "integrative" way of practicing is what makes the Myrna Brind Center so unique and effective.

We welcome you to our Center, and we think you'll agree that our new state-of-the-art facilities create an environment that allows the healing process to start the moment you walk through the door. The space is architecturally magnificent and bathed in light from high windows, as well as ceiling and glass panels. We also have a tranquil outdoor healing garden accessible from our suite.

Brind-Marcus Center now open

Our professional staff includes board-certified physicians with expertise in using diet and nutritional supplements and herbal and homeopathic medicines. Our physicians treat adults and children and are able to address either common health problems or complex medical conditions. They are available to work with you directly or in close consultation with your primary care provider or specialist.

The Center staff also includes acupuncturists, nurses and psychologists. And we have practitioners who can teach you to access the healing potential of your mind and spirit. We all work closely together in order to collaborate on treatment strategies and coordinate your care.

Based at Thomas Jefferson University's main campus, our academic program promotes research and educational activities related to integrative medicine. Researchers study health outcomes of all patients treated through our programs. Collaborative study protocols are developed with Jefferson clinical investigators and basic scientists. Our academic program has been providing professional education programs in integrative medicine for physicians, medical students, nurses and other health providers since 1995.

The Center is located at: 925 Chestnut Street Suite 120 Philadelphia, PA 19107 215-955-2221

Please enter the building by the 10th Street entrance between Chestnut and Market Streets on the east side of Chestnut (to avoid the steps at the 925 Chestnut Street entrance).

Academic Title: Professor

Executive and Medical Director of the Jefferson-Myrna Brind Center of Integrative Medicine

Excerpt from:
Myrna Brind Center of Integrative Medicine at Jefferson ...

Traditional Chinese Medicine (TCM)

For thousands of years, TCM has been practiced in China. TCM includes dietary recommendations and manipulation, Qigong, a form of meditation and exercise, Tuina, a form of massage, herbal medicine and acupuncture.

Traditional Chinese Medicine uses terms that may sound strange to our modern ears, but it is a highly logical and effective system of medicine. Our Western system and the TCM system both have the same goal - to maintain health and treat patients who experience illness or injury. These two methods have different views of the body. The TCM view is a more holistic view and the Western is more mechanistic and linear. These two systems can often be combined for the benefit of the patient, thus the term 'Integrative Medicine' as opposed to 'complementary' or 'alternative'.

A melding of Western medicine with complementary, alternative and holistic modalities, integrative medicine offers many healing options. It is a gentle, comprehensive approach to achieving wellness and maintaining health, while honoring an animal's innate healing power.

One of our great joys as veterinarians is developing personal relationships with patients and their caregivers. We provide a welcoming atmosphere (lower lighting, calming music, blankets for comfort, ample time for an unhurried visit), and yummy treats (if appropriate and allowed) in an effort to create a relaxed and enjoyable experience. You will be present during the exam and treatment and engaged in discussion about nutrition, exercise, and Tuina, a gentle, easy-to-learn method of body work. Time and intention (or attention) are key components to forming a partnership in caring for your pet and promoting his or her health and healing.

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Holistic Medicine - Newtown Veterinary Hospital, LLC

Dr. Rosenzweig offers natural therapies and supportive care for patients with cancer or other life-challenging illnesses.

Please see Dr. Rosenzweigs website for more information: http://www.StevenRosenzweigMD.net

Steven Rosenzweig, MD graduated the University of Pennsylvania School of Medicine in 1986 and completed his residency training in Emergency Medicine at Jefferson University Hospital in 1989. He was a full-time, Jefferson physician until 2007; during that time he served as Founding Medical and Academic Director of the Thomas Jefferson University Center of Integrative Medicine, which opened its doors in 1998. In 2007 he established his independent, private practice in Integrative Medicine and also joined the teaching faculty of Drexel University College of Medicine.

Dr. Rosenzweig is Board Certified in Emergency Medicine and in Palliative Medicine. He extended his medical training through the study of Anthroposophical Medicine, a European-based system of Integrative Medicine. He participated in professional training under the direction of Jon Kabat-Zinn, PhD, founder of the Stress Reduction Clinic at the University of Massachusetts Medical Center (UMMC), and has completed the Teacher Development Intensive in Mindfulness-Based Stress Reduction offered at the Stress Reduction Clinic at UMMC. He also completed Professional Certification Training in Interactive Guided Imagerysm through the Academy for Guided Imagery.

Dr. Rosenzweig is Clinical Associate Professor at Drexel University College of Medicine where he is Director of the Progam in Medical Humanism and Professional Values in the Office of Educational Affairs. He directs courses in Bioethics, Community Service Learning, and Professionalism. He teaches mindfulness and Integrative Medicine, and has been developing mind-body projects as part of the community service curriculum. He is also an Adjunct Associate Professor at Jefferson Medical College where he currently lectures on botanical medicine and racial disparities in healthcare. Dr Rosenzweig is a member of the medical staff of Hahnemann University Hospital and Abington Memorial Hospital.

Excerpt from:
Integrative Medicine - Healing Arts Center

Abstract

Adipose-derived stem cells (ADSCs) are a subset of mesenchymal stem cells (MSCs) that possess many of the same regenerative properties as other MSCs. However, the ubiquitous presence of ADSCs and their ease of access in human tissue have led to a burgeoning field of research. The plastic surgeon is uniquely positioned to harness this technology because of the relative frequency in which they perform procedures such as liposuction and autologous fat grafting. This review examines the current landscape of ADSC isolation and identification, summarizes the current applications of ADSCs in the field of plastic surgery, discusses the risks associated with their use, current barriers to universal clinical translatability, and surveys the latest research which may help to overcome these obstacles.

Recent advances in regenerative medicine, in particular the discovery of multipotent, easily accessible stem cells such as adipose-derived stem cells (ADSCs), have provided the opportunity of using autologous stem cell transplants as regenerative therapies. The field of plastic surgery, centred on the restoration and enhancement of the body, is logically positioned to utilize such new technologies focused on the repair and replacement of diseased cells and tissues [1]. The ability of stem cells to self-renew, to secrete trophic factors and to differentiate into different cell types has allowed for the development of more flexible therapies to redefine the classic autologous tissue transplant and offer more customizable treatment options. ADSCs are being utilized for a variety of different applications in plastic surgery [2-11], and as our understanding of the basic science of stem cells continues to develop, the plastic surgeon should be prepared for the translational and clinical implications of this progress.

Adipose-derived stem cells are particularly useful as they can be easily harvested with minimal donor site morbidity and have a differentiation potential similar to other MSCs [12, 13]. In addition, ADSCs have higher yields and greater proliferative rates in culture when compared to bone marrow stromal cells [14-16]. The discovery that ADSCs are not only precursors to adipocytes but also are multipotent progenitors to a variety of cells [17] including osteoblasts, chondrocytes, myocytes, epithelial cells and neuronal cells [18], creates the potential to treat a variety of tissue defects from a single, easily accessible autologous cell source.

Adult stem cell research has made significant strides as a therapeutic modality in recent years. However, there remain significant barriers to the safe and efficacious use of stem cell therapies. With regard to ADSCs, this includes better defining the source population of multipotent cells, optimizing the isolation of these cells in compliance with regulatory standards, and better understanding the behaviour of ADSCs in their transplanted niche. The purpose of this review is to (i) explore the utilization of ADSCs in plastic surgery, (ii) describe the current limitations of ADSC treatments with regard to developing translatable clinical therapies and (iii) describe certain techniques used in our laboratory that may help overcome these barriers. Understanding the current status of clinical ADSC treatments and defining the challenges ahead may bring us closer to achieving desired outcome while minimizing unwanted side effects with these therapies.

The most commonly published method of ADSC isolation involves enzymatic digestion of lipoaspirate to release the stromal vascular fraction (SVF) of cells which include stromal & endothelial cells, pericytes, various white blood cells, red blood cells and stem/progenitor cells [19]. The enzyme preparations used to achieve this fraction include dispase, trypsin and more commonly collagenase. In our laboratory, we take freshly harvested lipoaspirate and wash it with sterile 1% PBS until golden in colour. The adipose tissue is then digested with 0.01% collagenase/PBS solution at a ratio of 1ml of enzyme solution to 1cm3 of adipose tissue. This mixture is incubated at 37C with intermittent agitation until it becomes cloudy (usually 30min.). The infranatant is then carefully aspirated, transferred to 50ml conical tubes and centrifuged at 706g for 8min. The supernatant is discarded and resulting pellet, the SVF, is resuspended in control media [DMEM supplemented with 10% foetal bovine serum (FBS), 500IU penicillin and 500g streptomycin; Mediatech, Manassas, VA, USA]. The cells are then counted and plated in uncoated T75 flasks at a concentration of 1106 cells. Consistently, 20mg of lipoaspirate is ample tissue to harvest an adequate yield of SVF (>1107 cells).

In 2006, the International Society for Cellular Therapy (ICTS) defined a set of minimal criteria for identifying cells as ADSCs. These include plastic adherence while maintained in standard culture conditions, expression of CD73, CD90 and CD105 while lacking the expression of CD45, CD34, CD14 or CD11b, CD79 or CD19 and HLA-DR surface molecules [20]. In conjunction with the International Federation for Adipose Therapeutics and Science in 2013, the ICTS has denoted additional surface markers CD13, CD29 and CD44 as being constitutively expressed at >80% on the surface of ADSCs, while CD31, CD45 and CD235a are the primary negative markers that should be expressed on less than 2% of the cells [19]. Ultimately, the viability of the isolated cells should exceed 70% and the presence of at least two positive and two negative markers are necessary for foundational phenotyping. Finally, ADSCs must possess the ability to differentiate into osteoblasts, adipocytes and chondroblasts.

Identification of ADSCs in our laboratory is accomplished by labelling our plastic-adherent cells with a mesenchymal stem cell (MSC) phenotyping kit after the second passage (Miltenyi Biotec Inc, Auburn, CA, USA). Cells are analysed using a C6 Accuri Flow Cytometer (BD Biosciences, San Jose, CA, USA) which demonstrate positive staining for CD90 (81.3%), CD105 (86.6%) and CD73 (99.9%) and negative staining for CD14, CD20, CD34 and CD45 (1.97% Fig.1). To complete the identification of our ADSCs, we culture these cells in adipogenic, osteogenic, or chondrogenic conditions provided in commercially available kits (Cyagen Biosciences Inc., Sunnyvale, CA, USA). Cells subjected to adipogenic or osteogenic conditions reveal lipid droplets or calcium synthesis after staining with Oil Red O or Alizarin Red S, respectively, after fixation in 4% formalin. Cells subjected to chondrogenic conditions reveal proteoglycan synthesis upon staining with Alcian Blue after paraffin embedding (Fig.2). The ease at which ADSCs can be isolated has led to rapid and widespread translational applications.

Figure1. Flow cytometry analysis of isolated ADSCs after collagenase method. Cells stained (A) 81.3% positive for CD90, (B) 99.9% positive for CD73, (C) 86.6% positive for CD105 and (D) 1.97% positive for CD14, CD20, CD34 and CD45.

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Figure2. Undifferentated and differentiated ADSCs visualized using microscopy. Original magnification, 10. (A) Control stain uADSCs stained with Oil Red O (other controls not shown). (B) Staining with Alcian Blue revealing presence of chondroblasts. (C) Staining with Oil Red O revealing presence of adipocytes. (D) Staining with Alizarin Red S revealing presence of osteoblasts.

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A number of groups have described the isolation of ADSCs using non-enzymatic methods. Studies show that ADSCs reside in the infranatant layer of the suction canister after liposuction and that these cells can be expanded ex vivo. And while these cells exhibit phenotypic and differentiation potential similar to ADSCs isolated via collagenase digestion, their presence is significantly lower with reported yields ranging from a 3- to 19-fold decrease in comparison [21-24]. Interestingly, it has been found that multiple variables, including medical comorbidities of the patient, location adipose tissue stores, and the method in which this tissue is harvested, all affect the properties of the ADSCs therein. For example, diabetic patient fat stores have been found to contain fewer ADSCs with a reduced phenotypic expression profile and ability to proliferate [3]. The anatomical location of adipose tissue harvest also appears to have an effect on the yield and characteristics of the isolated ADSCs [25, 26]. More recently, Gnanasegaran etal. demonstrated that the gene expression levels and tendency towards specific germ layer differentiation is affected by whether the fat is harvested via liposuction versus lipectomy [27].

In Europe, ADSCs are considered Advanced Therapy Medicinal Products, as defined by the European Union (European Commission) 1394/2007 which contains rules for authorization, supervision, and pharmacovigilance regarding the summary of product characteristics, labelling, and packaging of Advanced Therapy Medicinal Products that are prepared commercially and in academic institutions [68]. This regulation refers to the European good manufacturing process (eGMP) rules [69]. The process of converting protocols, including collagenase-processed ADSCs, into a process that is compliant with eGMP requires assays that have had careful consideration of all the risks and benefits for the patient end user. As a result, the general recommendation on the use of enzyme-processed CAL in the clinical setting is not prohibited as this technique has been demonstrated to provide satisfying results in terms of long-term outcome, most likely because of the dramatic release of angiogenic growth factors and the differentiation of ADSCs into adipocytes and vascular endothelial cells [5, 10, 11].

In the United States, the Food and Drug Administration (FDA) regulates Human Cells and Tissue-Based Products (HCT/P) intended for human transplant and maintains two levels of classifications: 361 and 351 products. HCT/P 361 encompasses tissue (e.g. bone, ligaments, vein grafts, etc.) and their related procedures that take place in the same operative session, all of which fall under the jurisdiction of practice of medicine which is governed by state medical boards and professional societies; not the FDA. HCT/P 351, on the other hand, includes drugs/biologics (e.g. cultured cells, lymphocyte immune therapy, cell therapy involving the transfer of genetic material, etc.) which is fully governed by FDA [70, 71]. Regulation 21 CFR 1271 directly demonstrates the FDA's position on enzymatically isolated adipose stem cells derived from SVF for reconstructive purposes as beyond the scope of minimal manipulation and therefore, a drug [72]. Thus, the practical implication is the need for any surgeon who wishes to use ADSCs isolated via collagenase to submit an Investigational New Drug application to the FDA and have an approved Institutional Review Board with the referring Institution.

Given the time, expense and complexity of the regulatory issues surrounding ADSCs intended for transplantation, it is evident that U.S. physicians are discouraged to perform any cell-supplemented lipotransfer techniques in the current commonly accepted practices. Furthermore, automated devices for separating adipose stem cells are regulated as class III medical devices by the FDA, and currently, none are approved for human use in the United States. Kolle etal. demonstrated that CAL, when supplemented with ADSCs expanded ex vivo after collagenase digestion, yields superior results when compared to lipotransfer alone [38]. The FDA restrictions that would preclude such a study to be conducted in the United States prompt an impetus to develop methods for CAL that results in minimal manipulation of source adipose tissue.

In 2006, Yoshimura etal. described a cell population in the liposuction aspirate fluid that exhibited similar phenotypic properties to ADSCs harvested in the traditional manner (collagenase) from processed lipoaspirate cells; however, the yield was reduced by athird when comparing to the two methods [23]. Since that time, additional studies have been published touting the benefits of non-enzymatic ADSC isolation. In 2010, Francis etal. described a method of ADSC Rapid Isolation in ~30min. that excluded the use of collagenase, however, a significant disadvantage of this study was the low yield of ~250,000 cells from a starting volume of ~250ml liposuction aspirate fluid [21]. Zeng etal. describe a rapid and efficient form of non-enzymatic ADSC isolation in which adipose tissue is cut into tiny pieces and placed in culture flasks with 100% FBS in which the plastic-adherent cells were allowed to expand over a period of days [24]. One obvious downside to this method is the requirement to expand the cell population in calf serum. Most recently, Shah etal. describe aform of non-enzymatic ADSC isolation combining the cells of the liposuction aspirate fluid with the cells captured from the processed lipoaspirate tissue wash that is typically discarded prior to collagenase digestion [22]. They observed significant improvement in MSC-related phenotypic markers and similar adipogenic and osteogenic differentiation characteristics. While their isolation time was cut by one-third, they observed a 19-fold decrease in ADSC isolation when compared to the traditional method. In our laboratory, we have adopted a very similar protocol of non-enzymatic isolation that includes processing the processed lipoaspirate effluent. The primary difference in our protocol, however, is the method of plating cells. While Shah etal. plate the entire SVF pellets in T175 flasks, we resuspend our pellets in culture media and then plate the cells at specific concentrations. In one experiment for example, we plated the SVF pellet after collagenase digestion at a concentration of 5105 in a T75 flask. Concurrently, we plated the SVF pellet obtained after non-enzymatic isolation at 2106. After 6days of culture, these two flasks appeared nearly identical in terms of confluence, correlating to a fourfold decrease in ADSC harvest when using the latter method. The two cell populations were then analysed under flow cytometry as previously described. There is little difference in the phenotypic expression between the two populations as demonstrated by >80% expression of CD90, CD73 and CD105 and <5% expression of CD14, CD20, CD 34 and CD45 (Fig.3).

Figure3. Flow cytometry analysis of isolated ADSCs after rapid isolation (no collagenase). Cells stained (A) 85.8% positive for CD90, (B) 99.9% positive for CD73, (C) 99.4% positive for CD105 and (D) 3.79% positive for CD14, CD20, CD34 and CD45. (E) Collagenase-isolated ADSCs after 6days of primary culture seeded at 5105 in T75 flask. (F) Rapid isolation ADSCs after 6days primary culture seeded at 2106 in T75 flask.

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Most convincingly, Kolle etal. demonstrated a clear benefit to CAL over lipotransfer alone. They isolated and expanded ADSCs ex vivo from human cases followed by lipotransfer to the cases arms with or without ADSC supplementation. They demonstrated a 65% improvement in fat graft survival after 4months in the experimental group [38]. The major drawback to their experimental model was that to achieve these results, the 34ml of lipotransfer was supplemented with 6.5108 ADSCs or 2000 times the physiological level [38]. The methods of rapid isolation, previously mentioned, demonstrate the ability to isolate ADSCs without the aid of enzymatic digestion, but at a cost of greatly reduced yields. There is significant doubt that ADSCs used at such low concentrations would serve for any clinical benefit. As previously discussed, ex vivo expansion of ADSCs is not practical for application in the United States or other principalities with strict regulations. Therein lies an impetus to discover innovative methods of ADSC isolation and characterization of the regenerative components of the SVF that might yield similar results to concentrated ADSCs alone.

There is promise in capitalizing on the plastic-adherent properties of ADSCs as a form of non-enzymatic isolation. The same group that first described the isolation of cells from the LAF, Doi etal., has demonstrated that an adherent column of rayonpolyethylene non-woven fabrics may also be used to isolate ADSCs, though at an inferior yield to the traditional method [73]. Further advancements in harnessing the plastic-adherent properties of these cells are clearly needed as Buschmann etal. demonstrated that 3050% of ADSCs remain in suspension after 24hrs of primary culture [74].

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Implications for human adipose-derived stem cells in ...

Vision therapy: Can we train our sight?

Meghan Dukes

Table of Contents

What is vision therapy?

Who, What, When, and How Long?

What is vision therapy NOT?

Optometrists vs. Ophthalmologists

What does the research say?

Problems with vision therapy

References

The American Optometric Association defines vision therapy (VT) as a treatment plan used to correct or improve specific dysfunctions of the vision system. It includes, but is not limited to, the treatment of strabismus (turned eye), other dysfunctions of binocularity (eye teaming), amblyopic (lazy eye), accommodation (eye focusing), ocular motor function (general eye movement ability), and visual-perception-motor abilities. Optometric vision therapy is based upon a medically necessary plan of treatment which is designed to improve specific vision dysfunctions determined by standardized diagnostic criteria. Treatment plans encompass lenses, prisms, occlusion (eye patching), and other appropriate materials, modalities, and equipment (http://www.children-special-needs.org/vision_therapy/optometric_vision_therapy.html).

Vision therapy, also known as eye exercise, vision training, or orthoptics, (for a definition of these and other vision terms, go to this glossary of terms) is a non-surgical, physical therapy for binocular visual problems; however, vision therapy is not a direct treatment for learning disabilities (http://www.visiontherapy.org/).

Patients of any age can undergo vision therapy, but the treatment varies with each individual based on condition.

Successful vision therapy enhances and improves visual abilities such as fixation, acuity, visual memory, and binocular fusion, to name a few. Treatment plans involve prisms, lenses, computer modalities, and other materials.

The estimated program consists of weekly office visits, along with therapies to be conducted at home.

The treatment requires a great deal of commitment, for it may last for extensive periods of time depending on the individual. However, research has shown that the improvements due to vision therapy continue post-treatment (http://www.children-special-needs.org/questions_pf.html).

Further information regarding the dynamics of vision therapy may be located here.

It is important not to confuse optometric vision therapy with holistic practices such as the Bates Method, integrated vision therapy, or natural eye exercises. There is no scientific research or results that indicate these methods are valid; however, the internet is swarming with advertisements and descriptions of products that claim otherwise (http://www.vision-therapy.com).

The See Clearly Method is a series of daily eye exercises that claim to naturally reduce the need for glasses or contact lenses by toning and relaxing your eye muscles and relieving stress that hampers clear vision (http://www.seeclearlymethod.com/content/see clear.html).

A similar program called Vision for Life provides daily optical exercises that claim to stimulate and strengthen the muscles of the eye, resulting in improved vision and decreasing the dependency on glasses or contact lenses. Through testimonials, quotes, and flashy pictures, the Vision for Life website attempts to promote their method of natural vision improvement (http://www.rebuildyourvision.com).

Yoga is another branch of holistic therapy for vision. Yoga exercises claim to stretch, relax, and tone the optical nerves, which improves eyesight and alleviates tension, irritability, and itchiness of the eyes (http://www.indolink.com/Vasantha/eyeYoga.html).

The Bates Method is a psychosomatic approach to vision impairment. Without using strengthening exercises for the eye muscles, the Bates Method claims to improve visual clarity through relaxation exercises (http://www.seeing.org).

Several examples of holistic eye exercises can be found at Holistic-online.

An optometrist is licensed by the state to provide primary eye care, while an ophthalmologist is a physician of osteopathy who specializes in prevention of eye disease, eye care, and the visual system. The ophthalmologist is medically trained and licensed in all eye care, and is not trained in vision therapy.

Thus, support of vision therapy in the United States mainly comes from optometrists. Vision therapy saw its beginnings in the late 1800s in orthoptics, which is the science of correcting binocular vision impairments, and is now a form of vision therapy (http://www.vision-therapy.com/Glossary_of_Terms.htm). Present day ophthalmologists, for the most part, do not support vision therapy, and it has been speculated that this is due to the fact that they are trained to use drugs and surgery to treat eye dysfunction (http://www.children-special-needs.org/questions_pf.html).

There have been several concerns regarding the reliability and validity of the research surrounding the efficacy of vision therapy (http://members.aol.com/scottolitsky/vt.htm).

The sample population is not random, there are small numbers of patients in each study, and the results cannot be generalized because it does not reflect the population

Research that shows support of vision therapy have conflicts of interest in proving the

validity of vision therapy

There are many definitions of vision therapy found on the internet and in research studies. Thus, most of the data cannot be compared or generalized because vision therapy is defined differently (Coffey, B., Wick, B., Cotter, S., Scharre, J., & Horner, D., 1992).

Eye exercises, lenses, and perceptual training have not been scientifically proven to be useful. In addition, the problems that they intend to treat have never been proven to cause a learning disability.

As well, the American Academy of Ophthalmology and the American Academy of

Pediatrics made this statement regarding vision therapy:

No scientific evidence supports claims that the academic abilities of children with learning disabilities can be improved with treatments that are based on 1) visual training, including muscle exercises, ocular pursuit, tracking exercises, or 'training' glasses (with or without bifocals or prisms), 2) neurologic organizational training (laterality training, crawling, balance board, perceptual training), or 3) colored lenses. These more controversial methods of treatment may give parents and teachers a false sense of security that a child's reading difficulties are being addressed, which may delay proper instruction or remediation. The expense of these methods is unwarranted, and they cannot be substituted for appropriate educational measures. Claims of improved reading ... are almost always based on poorly controlled studies that typically rely on anecdotal information. These methods are without scientific validation. Their reported benefits can be explained by the traditional educational remedial techniques with which they are usually combined. (http://www.allaboutvision.com/parents/vision_therapy.htm)

A study by Adler (2002) concluded that vision therapy is an effective treatment for convergence insufficiency. The restoration of near point of convergence values to normal accompanied by a reduction in symptoms was concluded as successful treatment. Routine eye exercises were shown to have a highly significant (t = 14.61, p < 0.001) effect. Although treatment times were longer, the rate of success was greater than that reported by previous studies. As well, Verma & Singh (1997) reported that active visual therapy improved visual impairments in amblyopic children and young adults. The study used various methods of therapy on 160 patients, ranging from 3.5 to 25 years of age, who had lens implants, and visual acuity improved in the majority of the patients.

However, research surrounding the effects of visual therapy on learning disabilities has had mixed results. Having a visual impairment does not result in a learning disability, nor does the treatment of the impairment cure the disability. In fact, according to this study, there has been no scientific evidence for the efficacy of eye exercises in the elimination of the learning difficulties (Learning disabilities, dyslexia, and vision: a subject review, 1998). Vision therapy does not claim to directly treat the learning disability; however, it is an indirect influence, for it treats the visual impairments that influence reading and learning (http://www.visiontherapy.org). Research by Simons & Grisham (1987) supports a relationship between particular binocular disorders and reading problems. From these results, it can be hypothesized that if binocular disorders are alleviated, the reading disability, due to the positive correlation, will be less severe (Simons & Grisham, 1987).

Further research studies on the effects of vision therapy for eye disorders:

Accomodative Disorders (eye focusing problems)

Binocularity Dysfunctions (eye teaming problems)

Ocular Motility Dysfunctions (eye tracking problems

Strabismus (turned eye)

Amblyopic (lazy eye)

Adler, P. (2002). Efficacy of treatment for convergence insufficiency using vision therapy. Ophthalmic and Physiological Optics, 22, 565-571.

Cirigliano, Suzette. Glossary of Vision Terms. http://www.vision-therapy.com/Glossary_of_Terms.htm 9/22/2003

Cirigliano, Suzette. (2003). Research studies about vision therapy treatment. http://www.vision-therapy.com/vt_research_studies.htm 9/22/2003

Coffey, B., Wick, B., Cotter, S., Scharre, J., & Horner, D. (1992). Treatment options in intermittent exotropia: a critical appraisal. Optometry of Visual Science, 69, 386-404.

Glackin, Stella. (1990). The office eye workout; heres how to ensure that your VDT doesnt come to stand for Vision Destroying Terminal. East West, 20, 60.

http://members.aol.com/scottolitsky/vt.htm 9/22/2003

http://www.allaboutvision.com/parents/vision_therapy.htm 9/22/2003

http://www.indolink.com/Vasantha/eyeYoga.html 9/22/2003

http://www.seeclearlymethod.com 9/22/2003

http://www.seeing.org 9/22/2003

Learning disabilities, dyslexia, and vision: a subject review. (1998). Pediatrics, 102, 1217.

Optometrists Network. http://www.children-special-needs.org/questions_pf.html 9/22/2003

Press, L. J. Vision therapy FAQs. http://www.visiontherapy.org/vision-therapy/faqs/vision-therapy-FAQs.html 9/22/2003

Rouse, M. W. (1987). Management of binocular anomalies: efficacy of vision therapy in the treatment of accommodative deficiencies. American Journal of Physiological Optometry, 64, 415-420.

Simons, H. D., & Grisham, J.D. (1987). Binocular anomalies and reading problems. Journal of American Optometry Association, 58, 578-87.

Toufexis, A. (1989). Workouts for the eyes; therapies to improve visual performance get mixed reviews. Time, 133, 86.

Verma, A., & Singh, D. (1997). Active vision therapy for pseudophakic amblyopic. Journal of Cataract and Refractive Surgery, 23, 1089-1094.

Vision for life. (2002). Our program for rebuilding your vision naturally. http://www.rebuildyourvision.com/our_program.htm 9/22/2003

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Vision Therapy: Can We Train Our Sight (Vanderbilt.edu)

Points toRemember

Diabetic eye disease can affect many parts of the eye, including the retina, macula, lens and the optic nerve.

Diabetic eye disease is a group of eye conditions that can affect people with diabetes.

Diabetic eye disease also includes cataract and glaucoma:

All forms of diabetic eye disease have the potential to cause severe vision loss and blindness.

Chronically high blood sugar from diabetes is associated with damage to the tiny blood vessels in the retina, leading to diabetic retinopathy. The retina detects light and converts it to signals sent through the optic nerve to the brain. Diabetic retinopathy can cause blood vessels in the retina to leak fluid or hemorrhage (bleed), distorting vision. In its most advanced stage, new abnormal blood vessels proliferate (increase in number) on the surface of the retina, which can lead to scarring and cell loss in the retina.

Diabetic retinopathy may progress through four stages:

DME is the build-up of fluid (edema) in a region of the retina called the macula. The macula is important for the sharp, straight-ahead vision that is used for reading, recognizing faces, and driving. DME is the most common cause of vision loss among people with diabetic retinopathy. About half of all people with diabetic retinopathy will develop DME. Although it is more likely to occur as diabetic retinopathy worsens, DME can happen at any stage of the disease.

People with all types of diabetes (type 1, type 2, and gestational) are at risk for diabetic retinopathy. Risk increases the longer a person has diabetes. Between 40 and 45 percent of Americans diagnosed with diabetes have some stage of diabetic retinopathy, although only about half are aware of it. Women who develop or have diabetes during pregnancy may have rapid onset or worsening of diabetic retinopathy.

The same scene as viewed by a person normal vision (Top) and with (Center) advanced diabetic retinopathy. The floating spots are hemorrhages that require prompt treatment. DME (Bottom) causes blurred vision.

The early stages of diabetic retinopathy usually have no symptoms. The disease often progresses unnoticed until it affects vision. Bleeding from abnormal retinal blood vessels can cause the appearance of floating spots. These spots sometimes clear on their own. But without prompt treatment, bleeding often recurs, increasing the risk of permanent vision loss. If DME occurs, it can cause blurred vision.

Diabetic retinopathy and DME are detected during a comprehensive dilated eye exam that includes:

A comprehensive dilated eye exam allows the doctor to check the retina for:

If DME or severe diabetic retinopathy is suspected, a fluorescein angiogram may be used to look for damaged or leaky blood vessels. In this test, a fluorescent dye is injected into the bloodstream, often into an arm vein. Pictures of the retinal blood vessels are taken as the dye reaches the eye.

Vision lost to diabetic retinopathy is sometimes irreversible. However, early detection and treatment can reduce the risk of blindness by 95 percent. Because diabetic retinopathy often lacks early symptoms, people with diabetes should get a comprehensive dilated eye exam at least once a year. People with diabetic retinopathy may need eye exams more frequently. Women with diabetes who become pregnant should have a comprehensive dilated eye exam as soon as possible. Additional exams during pregnancy may be needed.

Studies such as the Diabetes Control and Complications Trial (DCCT) have shown that controlling diabetes slows the onset and worsening of diabetic retinopathy. DCCT study participants who kept their blood glucose level as close to normal as possible were significantly less likely than those without optimal glucose control to develop diabetic retinopathy, as well as kidney and nerve diseases. Other trials have shown that controlling elevated blood pressure and cholesterol can reduce the risk of vision loss among people with diabetes.

Treatment for diabetic retinopathy is often delayed until it starts to progress to PDR, or when DME occurs. Comprehensive dilated eye exams are needed more frequently as diabetic retinopathy becomes more severe. People with severe nonproliferative diabetic retinopathy have a high risk of developing PDR and may need a comprehensive dilated eye exam as often as every 2 to 4 months.

DME can be treated with several therapies that may be used alone or in combination.

Anti-VEGF Injection Therapy. Anti-VEGF drugs are injected into the vitreous gel to block a protein called vascular endothelial growth factor (VEGF), which can stimulate abnormal blood vessels to grow and leak fluid. Blocking VEGF can reverse abnormal blood vessel growth and decrease fluid in the retina. Available anti-VEGF drugs include Avastin (bevacizumab), Lucentis (ranibizumab), and Eylea (aflibercept). Lucentis and Eylea are approved by the U.S. Food and Drug Administration (FDA) for treating DME. Avastin was approved by the FDA to treat cancer, but is commonly used to treat eye conditions, including DME.

The NEI-sponsored Diabetic Retinopathy Clinical Research Network compared Avastin, Lucentis, and Eylea in a clinical trial. The study found all three drugs to be safe and effective for treating most people with DME. Patients who started the trial with 20/40 or better vision experienced similar improvements in vision no matter which of the three drugs they were given. However, patients who started the trial with 20/50 or worse vision had greater improvements in vision with Eylea.

Most people require monthly anti-VEGF injections for the first six months of treatment. Thereafter, injections are needed less often: typically three to four during the second six months of treatment, about four during the second year of treatment, two in the third year, one in the fourth year, and none in the fifth year. Dilated eye exams may be needed less often as the disease stabilizes.

Avastin, Lucentis, and Eylea vary in cost and in how often they need to be injected, so patients may wish to discuss these issues with an eye care professional.

The retina of a person with diabetic retinopathy and DME, as viewed by optical coherence tomography (OCT). The two images were taken before (Top) and after anti-VEGF treatment (Bottom). The dip in the retina is the fovea, a region of the macula where vision is normally at its sharpest. Note the swelling of the macula and elevation of the fovea before treatment.

Focal/grid macular laser surgery. In focal/grid macular laser surgery, a few to hundreds of small laser burns are made to leaking blood vessels in areas of edema near the center of the macula. Laser burns for DME slow the leakage of fluid, reducing swelling in the retina. The procedure is usually completed in one session, but some people may need more than one treatment. Focal/grid laser is sometimes applied before anti-VEGF injections, sometimes on the same day or a few days after an anti-VEGF injection, and sometimes only when DME fails to improve adequately after six months of anti-VEGF therapy.

Corticosteroids. Corticosteroids, either injected or implanted into the eye, may be used alone or in combination with other drugs or laser surgery to treat DME. The Ozurdex (dexamethasone) implant is for short-term use, while the Iluvien (fluocinolone acetonide) implant is longer lasting. Both are biodegradable and release a sustained dose of corticosteroids to suppress DME. Corticosteroid use in the eye increases the risk of cataract and glaucoma. DME patients who use corticosteroids should be monitored for increased pressure in the eye and glaucoma.

For decades, PDR has been treated with scatter laser surgery, sometimes called panretinal laser surgery or panretinal photocoagulation. Treatment involves making 1,000 to 2,000 tiny laser burns in areas of the retina away from the macula. These laser burns are intended to cause abnormal blood vessels to shrink. Although treatment can be completed in one session, two or more sessions are sometimes required. While it can preserve central vision, scatter laser surgery may cause some loss of side (peripheral), color, and night vision. Scatter laser surgery works best before new, fragile blood vessels have started to bleed. Recent studies have shown that anti-VEGF treatment not only is effective for treating DME, but is also effective for slowing progression of diabetic retinopathy, including PDR, so anti-VEGF is increasingly used as a first-line treatment for PDR.

A vitrectomy is the surgical removal of the vitreous gel in the center of the eye. The procedure is used to treat severe bleeding into the vitreous, and is performed under local or general anesthesia. Ports (temporary water-tight openings) are placed in the eye to allow the surgeon to insert and remove instruments, such as a tiny light or a small vacuum called a vitrector. A clear salt solution is gently pumped into the eye through one of the ports to maintain eye pressure during surgery and to replace the removed vitreous. The same instruments used during vitrectomy also may be used to remove scar tissue or to repair a detached retina.

Vitrectomy may be performed as an outpatient procedure or as an inpatient procedure, usually requiring a single overnight stay in the hospital. After treatment, the eye may be covered with a patch for days to weeks and may be red and sore. Drops may be applied to the eye to reduce inflammation and the risk of infection. If both eyes require vitrectomy, the second eye usually will be treated after the first eye has recovered.

An eye care professional can help locate and make referrals to low vision and rehabilitation services and suggest devices that may help make the most of remaining vision. Many community organizations and agencies offer information about low vision counseling, training, and other special services for people with visual impairment. A nearby school of medicine or optometry also may provide low vision and rehabilitation services.

The NEI is conducting and supporting research that seeks better ways to detect, treat, and prevent vision loss in people with diabetes. This research is being conducted in labs and clinical centers across the country.

For example, the Diabetic Retinopathy Clinical Research Network (DRCR.net) conducts large multi-center trials to test new therapies for diabetic eye disease, and to compare different therapies. The network formed in 2002 and comprises more than 350 physicians practicing at more than 140 clinical sites across the country. Many of the sites are private practice eye clinics, enabling the network to quickly bring innovative treatments from research into community practice.

NEI-funded scientists are also seeking ways to detect diabetic retinopathy at earlier stages. For example, researchers are harnessing a technology called adaptive optics (AO) to improve imaging techniques such as OCT. AO was developed by astronomers seeking to improve the resolution of their telescopes by filtering out distortions in the atmosphere. In the clinic, diagnostic devices that use AO may improve the detection of subtle changes in retinal tissue and bloodvessels.

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