StemCell Therapy

Diabetes exacts its toll on many Americans, young and old. For years, researchers have painstakingly dissected this complicated disease caused by the destruction of insulin producing islet cells of the pancreas. Despite progress in understanding the underlying disease mechanisms for diabetes, there is still a paucity of effective therapies. For years investigators have been making slow, but steady, progress on experimental strategies for pancreatic transplantation and islet cell replacement. Now, researchers have turned their attention to adult stem cells that appear to be precursors to islet cells and embryonic stem cells that produce insulin.

For decades, diabetes researchers have been searching for ways to replace the insulin-producing cells of the pancreas that are destroyed by a patient's own immune system. Now it appears that this may be possible. Each year, diabetes affects more people and causes more deaths than breast cancer and AIDS combined. Diabetes is the seventh leading cause of death in the United States today, with nearly 200,000 deaths reported each year. The American Diabetes Association estimates that nearly 16 million people, or 5.9 percent of the United States population, currently have diabetes.

Diabetes is actually a group of diseases characterized by abnormally high levels of the sugar glucose in the bloodstream. This excess glucose is responsible for most of the complications of diabetes, which include blindness, kidney failure, heart disease, stroke, neuropathy, and amputations. Type 1 diabetes, also known as juvenile-onset diabetes, typically affects children and young adults. Diabetes develops when the body's immune system sees its own cells as foreign and attacks and destroys them. As a result, the islet cells of the pancreas, which normally produce insulin, are destroyed. In the absence of insulin, glucose cannot enter the cell and glucose accumulates in the blood. Type 2 diabetes, also called adult-onset diabetes, tends to affect older, sedentary, and overweight individuals with a family history of diabetes. Type 2 diabetes occurs when the body cannot use insulin effectively. This is called insulin resistance and the result is the same as with type 1 diabetesa build up of glucose in the blood.

There is currently no cure for diabetes. People with type 1 diabetes must take insulin several times a day and test their blood glucose concentration three to four times a day throughout their entire lives. Frequent monitoring is important because patients who keep their blood glucose concentrations as close to normal as possible can significantly reduce many of the complications of diabetes, such as retinopathy (a disease of the small blood vessels of the eye which can lead to blindness) and heart disease, that tend to develop over time. People with type 2 diabetes can often control their blood glucose concentrations through a combination of diet, exercise, and oral medication. Type 2 diabetes often progresses to the point where only insulin therapy will control blood glucose concentrations.

Each year, approximately 1,300 people with type 1 diabetes receive whole-organ pancreas transplants. After a year, 83 percent of these patients, on average, have no symptoms of diabetes and do not have to take insulin to maintain normal glucose concentrations in the blood. However, the demand for transplantable pancreases outweighs their availability. To prevent the body from rejecting the transplanted pancreas, patients must take powerful drugs that suppress the immune system for their entire lives, a regimen that makes them susceptible to a host of other diseases. Many hospitals will not perform a pancreas transplant unless the patient also needs a kidney transplant. That is because the risk of infection due to immunosuppressant therapy can be a greater health threat than the diabetes itself. But if a patient is also receiving a new kidney and will require immunosuppressant drugs anyway, many hospitals will perform the pancreas transplant.

Over the past several years, doctors have attempted to cure diabetes by injecting patients with pancreatic islet cellsthe cells of the pancreas that secrete insulin and other hormones. However, the requirement for steroid immunosuppressant therapy to prevent rejection of the cells increases the metabolic demand on insulin-producing cells and eventually they may exhaust their capacity to produce insulin. The deleterious effect of steroids is greater for islet cell transplants than for whole-organ transplants. As a result, less than 8 percent of islet cell transplants performed before last year had been successful.

More recently, James Shapiro and his colleagues in Edmonton, Alberta, Canada, have developed an experimental protocol for transplanting islet cells that involves using a much larger amount of islet cells and a different type of immunosuppressant therapy. In a recent study, they report that [17], seven of seven patients who received islet cell transplants no longer needed to take insulin, and their blood glucose concentrations were normal a year after surgery. The success of the Edmonton protocol is now being tested at 10 centers around the world.

If the success of the Edmonton protocol can be duplicated, many hurdles still remain in using this approach on a wide scale to treat diabetes. First, donor tissue is not readily available. Islet cells used in transplants are obtained from cadavers, and the procedure requires at least two cadavers per transplant. The islet cells must be immunologically compatible, and the tissue must be freshly obtainedwithin eight hours of death. Because of the shortage of organ donors, these requirements are difficult to meet and the waiting list is expected to far exceed available tissue, especially if the procedure becomes widely accepted and available. Further, islet cell transplant recipients face a lifetime of immunosuppressant therapy, which makes them susceptible to other serious infections and diseases.

Before discussing cell-based therapies for diabetes, it is important to understand how the pancreas develops. In mammals, the pancreas contains three classes of cell types: the ductal cells, the acinar cells, and the endocrine cells. The endocrine cells produce the hormones glucagon, somatostatin, pancreatic polypeptide (PP), and insulin, which are secreted into the blood stream and help the body regulate sugar metabolism. The acinar cells are part of the exocrine system, which manufactures digestive enzymes, and ductal cells from the pancreatic ducts, which connect the acinar cells to digestive organs.

In humans, the pancreas develops as an outgrowth of the duodenum, a part of the small intestine. The cells of both the exocrine systemthe acinar cellsand of the endocrine systemthe islet cellsseem to originate from the ductal cells during development. During development these endocrine cells emerge from the pancreatic ducts and form aggregates that eventually form what is known as Islets of Langerhans. In humans, there are four types of islet cells: the insulin-producing beta cells; the alpha cells, which produce glucagon; the delta cells, which secrete somatostatin; and the PP-cells, which produce pancreatic polypeptide. The hormones released from each type of islet cell have a role in regulating hormones released from other islet cells. In the human pancreas, 65 to 90 percent of islet cells are beta cells, 15 to 20 percent are alpha-cells, 3 to 10 percent are delta cells, and one percent is PP cells. Acinar cells form small lobules contiguous with the ducts (see Figure 7.1. Insulin Production in the Human Pancreas). The resulting pancreas is a combination of a lobulated, branched acinar gland that forms the exocrine pancreas, and, embedded in the acinar gland, the Islets of Langerhans, which constitute the endocrine pancreas.

Figure 7.1. Insulin Production in the Human Pancreas. The pancreas is located in the abdomen, adjacent to the duodenum (the first portion of the small intestine). A cross-section of the pancreas shows the islet of Langerhans which is the functional unit of the endocrine pancreas. Encircled is the beta cell that synthesizes and secretes insulin. Beta cells are located adjacent to blood vessels and can easily respond to changes in blood glucose concentration by adjusting insulin production. Insulin facilitates uptake of glucose, the main fuel source, into cells of tissues such as muscle.

( 2001 Terese Winslow, Lydia Kibiuk)

During fetal development, new endocrine cells appear to arise from progenitor cells in the pancreatic ducts. Many researchers maintain that some sort of islet stem cell can be found intermingled with ductal cells during fetal development and that these stem cells give rise to new endocrine cells as the fetus develops. Ductal cells can be distinguished from endocrine cells by their structure and by the genes they express. For example, ductal cells typically express a gene known as cytokeratin-9 (CK-9), which encodes a structural protein. Beta islet cells, on the other hand, express a gene called PDX-1, which encodes a protein that initiates transcription from the insulin gene. These genes, called cell markers, are useful in identifying particular cell types.

Following birth and into adulthood, the source of new islet cells is not clear, and some controversy exists over whether adult stem cells exist in the pancreas. Some researchers believe that islet stem cell-like cells can be found in the pancreatic ducts and even in the islets themselves. Others maintain that the ductal cells can differentiate into islet precursor cells, while others hold that new islet cells arise from stem cells in the blood. Researchers are using several approaches for isolating and cultivating stem cells or islet precursor cells from fetal and adult pancreatic tissue. In addition, several new promising studies indicate that insulin-producing cells can be cultivated from embryonic stem cell lines.

In developing a potential therapy for patients with diabetes, researchers hope to develop a system that meets several criteria. Ideally, stem cells should be able to multiply in culture and reproduce themselves exactly. That is, the cells should be self-renewing. Stem cells should also be able to differentiate in vivo to produce the desired kind of cell. For diabetes therapy, it is not clear whether it will be desirable to produce only beta cellsthe islet cells that manufacture insulinor whether other types of pancreatic islet cells are also necessary. Studies by Bernat Soria and colleagues, for example, indicate that isolated beta cellsthose cultured in the absence of the other types of islet cellsare less responsive to changes in glucose concentration than intact islet clusters made up of all islet cell types. Islet cell clusters typically respond to higher-than-normal concentrations of glucose by releasing insulin in two phases: a quick release of high concentrations of insulin and a slower release of lower concentrations of insulin. In this manner the beta cells can fine-tune their response to glucose. Extremely high concentrations of glucose may require that more insulin be released quickly, while intermediate concentrations of glucose can be handled by a balance of quickly and slowly released insulin.

Isolated beta cells, as well as islet clusters with lower-than-normal amounts of non-beta cells, do not release insulin in this biphasic manner. Instead insulin is released in an all-or-nothing manner, with no fine-tuning for intermediate concentrations of glucose in the blood [5, 18]. Therefore, many researchers believe that it will be preferable to develop a system in which stem or precursor cell types can be cultured to produce all the cells of the islet cluster in order to generate a population of cells that will be able to coordinate the release of the appropriate amount of insulin to the physiologically relevant concentrations of glucose in the blood.

Several groups of researchers are investigating the use of fetal tissue as a potential source of islet progenitor cells. For example, using mice, researchers have compared the insulin content of implants from several sources of stem cellsfresh human fetal pancreatic tissue, purified human islets, and cultured islet tissue [2]. They found that insulin content was initially higher in the fresh tissue and purified islets. However, with time, insulin concentration decreased in the whole tissue grafts, while it remained the same in the purified islet grafts. When cultured islets were implanted, however, their insulin content increased over the course of three months. The researchers concluded that precursor cells within the cultured islets were able to proliferate (continue to replicate) and differentiate (specialize) into functioning islet tissue, but that the purified islet cells (already differentiated) could not further proliferate when grafted. Importantly, the researchers found, however, that it was also difficult to expand cultures of fetal islet progenitor cells in culture [7].

Many researchers have focused on culturing islet cells from human adult cadavers for use in developing transplantable material. Although differentiated beta cells are difficult to proliferate and culture, some researchers have had success in engineering such cells to do this. For example, Fred Levine and his colleagues at the University of California, San Diego, have engineered islet cells isolated from human cadavers by adding to the cells' DNA special genes that stimulate cell proliferation. However, because once such cell lines that can proliferate in culture are established, they no longer produce insulin. The cell lines are further engineered to express the beta islet cell gene, PDX-1, which stimulates the expression of the insulin gene. Such cell lines have been shown to propagate in culture and can be induced to differentiate to cells, which produce insulin. When transplanted into immune-deficient mice, the cells secrete insulin in response to glucose. The researchers are currently investigating whether these cells will reverse diabetes in an experimental diabetes model in mice [6, 8].

These investigators report that these cells do not produce as much insulin as normal islets, but it is within an order of magnitude. The major problem in dealing with these cells is maintaining the delicate balance between growth and differentiation. Cells that proliferate well do not produce insulin efficiently, and those that do produce insulin do not proliferate well. According to the researchers, the major issue is developing the technology to be able to grow large numbers of these cells that will reproducibly produce normal amounts of insulin [9].

Another promising source of islet progenitor cells lies in the cells that line the pancreatic ducts. Some researchers believe that multipotent (capable of forming cells from more than one germ layer) stem cells are intermingled with mature, differentiated duct cells, while others believe that the duct cells themselves can undergo a differentiation, or a reversal to a less mature type of cell, which can then differentiate into an insulin-producing islet cell.

Susan Bonner-Weir and her colleagues reported last year that when ductal cells isolated from adult human pancreatic tissue were cultured, they could be induced to differentiate into clusters that contained both ductal and endocrine cells. Over the course of three to four weeks in culture, the cells secreted low amounts of insulin when exposed to low concentrations of glucose, and higher amounts of insulin when exposed to higher glucose concentrations. The researchers have determined by immunochemistry and ultrastructural analysis that these clusters contain all of the endocrine cells of the islet [4].

Bonner-Weir and her colleagues are working with primary cell cultures from duct cells and have not established cells lines that can grow indefinitely. However the cells can be expanded. According to the researchers, it might be possible in principle to do a biopsy and remove duct cells from a patient and then proliferate the cells in culture and give the patient back his or her own islets. This would work with patients who have type 1 diabetes and who lack functioning beta cells, but their duct cells remain intact. However, the autoimmune destruction would still be a problem and potentially lead to destruction of these transplanted cells [3]. Type 2 diabetes patients might benefit from the transplantation of cells expanded from their own duct cells since they would not need any immunosuppression. However, many researchers believe that if there is a genetic component to the death of beta cells, then beta cells derived from ductal cells of the same individual would also be susceptible to autoimmune attack.

Some researchers question whether the ductal cells are indeed undergoing a dedifferentiation or whether a subset of stem-like or islet progenitors populate the pancreatic ducts and may be co-cultured along with the ductal cells. If ductal cells die off but islet precursors proliferate, it is possible that the islet precursor cells may overtake the ductal cells in culture and make it appear that the ductal cells are dedifferentiating into stem cells. According to Bonner-Weir, both dedifferentiated ductal cells and islet progenitor cells may occur in pancreatic ducts.

Ammon Peck of the University of Florida, Vijayakumar Ramiya of Ixion Biotechnology in Alachua, FL, and their colleagues [13, 14] have also cultured cells from the pancreatic ducts from both humans and mice. Last year, they reported that pancreatic ductal epithelial cells from adult mice could be cultured to yield islet-like structures similar to the cluster of cells found by Bonner-Weir. Using a host of islet-cell markers they identified cells that produced insulin, glucagon, somatostatin, and pancreatic polypeptide. When the cells were implanted into diabetic mice, the diabetes was reversed.

Joel Habener has also looked for islet-like stem cells from adult pancreatic tissue. He and his colleagues have discovered a population of stem-like cells within both the adult pancreas islets and pancreatic ducts. These cells do not express the marker typical of ductal cells, so they are unlikely to be ductal cells, according to Habener. Instead, they express a marker called nestin, which is typically found in developing neural cells. The nestin-positive cells do not express markers typically found in mature islet cells. However, depending upon the growth factors added, the cells can differentiate into different types of cells, including liver, neural, exocrine pancreas, and endocrine pancreas, judged by the markers they express, and can be maintained in culture for up to eight months [20].

The discovery of methods to isolate and grow human embryonic stem cells in 1998 renewed the hopes of doctors, researchers, and diabetes patients and their families that a cure for type 1 diabetes, and perhaps type 2 diabetes as well, may be within striking distance. In theory, embryonic stem cells could be cultivated and coaxed into developing into the insulin-producing islet cells of the pancreas. With a ready supply of cultured stem cells at hand, the theory is that a line of embryonic stem cells could be grown up as needed for anyone requiring a transplant. The cells could be engineered to avoid immune rejection. Before transplantation, they could be placed into nonimmunogenic material so that they would not be rejected and the patient would avoid the devastating effects of immunosuppressant drugs. There is also some evidence that differentiated cells derived from embryonic stem cells might be less likely to cause immune rejection (see Chapter 10. Assessing Human Stem Cell Safety). Although having a replenishable supply of insulin-producing cells for transplant into humans may be a long way off, researchers have been making remarkable progress in their quest for it. While some researchers have pursued the research on embryonic stem cells, other researchers have focused on insulin-producing precursor cells that occur naturally in adult and fetal tissues.

Since their discovery three years ago, several teams of researchers have been investigating the possibility that human embryonic stem cells could be developed as a therapy for treating diabetes. Recent studies in mice show that embryonic stem cells can be coaxed into differentiating into insulin-producing beta cells, and new reports indicate that this strategy may be possible using human embryonic cells as well.

Last year, researchers in Spain reported using mouse embryonic stem cells that were engineered to allow researchers to select for cells that were differentiating into insulin-producing cells [19]. Bernat Soria and his colleagues at the Universidad Miguel Hernandez in San Juan, Alicante, Spain, added DNA containing part of the insulin gene to embryonic cells from mice. The insulin gene was linked to another gene that rendered the mice resistant to an antibiotic drug. By growing the cells in the presence of an antibiotic, only those cells that were activating the insulin promoter were able to survive. The cells were cloned and then cultured under varying conditions. Cells cultured in the presence of low concentrations of glucose differentiated and were able to respond to changes in glucose concentration by increasing insulin secretion nearly sevenfold. The researchers then implanted the cells into the spleens of diabetic mice and found that symptoms of diabetes were reversed.

Manfred Ruediger of Cardion, Inc., in Erkrath, Germany, is using the approach developed by Soria and his colleagues to develop insulin-producing human cells derived from embryonic stem cells. By using this method, the non-insulin-producing cells will be killed off and only insulin-producing cells should survive. This is important in ensuring that undifferentiated cells are not implanted that could give rise to tumors [15]. However, some researchers believe that it will be important to engineer systems in which all the components of a functioning pancreatic islet are allowed to develop.

Recently Ron McKay and his colleagues described a series of experiments in which they induced mouse embryonic cells to differentiate into insulin-secreting structures that resembled pancreatic islets [10]. McKay and his colleagues started with embryonic stem cells and let them form embryoid bodiesan aggregate of cells containing all three embryonic germ layers. They then selected a population of cells from the embryoid bodies that expressed the neural marker nestin (see Appendix B. Mouse Embryonic Stem Cells). Using a sophisticated five-stage culturing technique, the researchers were able to induce the cells to form islet-like clusters that resembled those found in native pancreatic islets. The cells responded to normal glucose concentrations by secreting insulin, although insulin amounts were lower than those secreted by normal islet cells (see Figure 7.2. Development of Insulin-Secreting Pancreatic-Like Cells From Mouse Embryonic Stem Cells). When the cells were injected into diabetic mice, they survived, although they did not reverse the symptoms of diabetes.

Figure 7.2. Development of Insulin-Secreting Pancreatic-Like Cells From Mouse Embryonic Stem Cells. Mouse embryonic stem cells were derived from the inner cell mass of the early embryo (blastocyst) and cultured under specific conditions. The embryonic stem cells (in blue) were then expanded and differentiated. Cells with markers consistent with islet cells were selected for further differentiation and characterization. When these cells (in purple) were grown in culture, they spontaneously formed three-dimentional clusters similar in structure to normal pancreatic islets. The cells produced and secreted insulin. As depicted in the chart, the pancreatic islet-like cells showed an increase in release of insulin as the glucose concentration of the culture media was increased. When the pancreatic islet-like cells were implanted in the shoulder of diabetic mice, the cells became vascularized, synthesized insulin, and maintained physical characteristics similar to pancreatic islets.

( 2001 Terese Winslow, Caitlin Duckwall)

According to McKay, this system is unique in that the embryonic cells form a functioning pancreatic islet, complete with all the major cell types. The cells assemble into islet-like structures that contain another layer, which contains neurons and is similar to intact islets from the pancreas [11]. Several research groups are trying to apply McKay's results with mice to induce human embryonic stem cells to differentiate into insulin-producing islets.

Recent research has also provided more evidence that human embryonic cells can develop into cells that can and do produce insulin. Last year, Melton, Nissim Benvinisty of the Hebrew University in Jerusalem, and Josef Itskovitz-Eldor of the Technion in Haifa, Israel, reported that human embryonic stem cells could be manipulated in culture to express the PDX-1 gene, a gene that controls insulin transcription [16]. In these experiments, researchers cultured human embryonic stem cells and allowed them to spontaneously form embryoid bodies (clumps of embryonic stem cells composed of many types of cells from all three germ layers). The embryoid bodies were then treated with various growth factors, including nerve growth factor. The researchers found that both untreated embryoid bodies and those treated with nerve growth factor expressed PDX-1. Embryonic stem cells prior to formation of the aggregated embryoid bodies did not express PDX-1. Because expression of the PDX-1 gene is associated with the formation of beta islet cells, these results suggest that beta islet cells may be one of the cell types that spontaneously differentiate in the embryoid bodies. The researchers now think that nerve growth factor may be one of the key signals for inducing the differentiation of beta islet cells and can be exploited to direct differentiation in the laboratory. Complementing these findings is work done by Jon Odorico of the University of Wisconsin in Madison using human embryonic cells of the same source. In preliminary findings, he has shown that human embryonic stem cells can differentiate and express the insulin gene [12].

More recently, Itskovitz-Eldor and his Technion colleagues further characterized insulin-producing cells in embryoid bodies [1]. The researchers found that embryonic stem cells that were allowed to spontaneously form embryoid bodies contained a significant percentage of cells that express insulin. Based on the binding of antibodies to the insulin protein, Itskovitz-Eldor estimates that 1 to 3 percent of the cells in embryoid bodies are insulin-producing beta-islet cells. The researchers also found that cells in the embryoid bodies express glut-2 and islet-specific glucokinase, genes important for beta cell function and insulin secretion. Although the researchers did not measure a time-dependent response to glucose, they did find that cells cultured in the presence of glucose secrete insulin into the culture medium. The researchers concluded that embryoid bodies contain a subset of cells that appear to function as beta cells and that the refining of culture conditions may soon yield a viable method for inducing the differentiation of beta cells and, possibly, pancreatic islets.

Taken together, these results indicate that the development of a human embryonic stem cell system that can be coaxed into differentiating into functioning insulin-producing islets may soon be possible.

Ultimately, type 1 diabetes may prove to be especially difficult to cure, because the cells are destroyed when the body's own immune system attacks and destroys them. This autoimmunity must be overcome if researchers hope to use transplanted cells to replace the damaged ones. Many researchers believe that at least initially, immunosuppressive therapy similar to that used in the Edmonton protocol will be beneficial. A potential advantage of embryonic cells is that, in theory, they could be engineered to express the appropriate genes that would allow them to escape or reduce detection by the immune system. Others have suggested that a technology should be developed to encapsulate or embed islet cells derived from islet stem or progenitor cells in a material that would allow small molecules such as insulin to pass through freely, but would not allow interactions between the islet cells and cells of the immune system. Such encapsulated cells could secrete insulin into the blood stream, but remain inaccessible to the immune system.

Before any cell-based therapy to treat diabetes makes it to the clinic, many safety issues must be addressed (see Chapter 10. Assessing Human Stem Cell Safety). A major consideration is whether any precursor or stem-like cells transplanted into the body might revert to a more pluripotent state and induce the formation of tumors. These risks would seemingly be lessened if fully differentiated cells are used in transplantation.

But before any kind of human islet-precursor cells can be used therapeutically, a renewable source of human stem cells must be developed. Although many progenitor cells have been identified in adult tissue, few of these cells can be cultured for multiple generations. Embryonic stem cells show the greatest promise for generating cell lines that will be free of contaminants and that can self renew. However, most researchers agree that until a therapeutically useful source of human islet cells is developed, all avenues of research should be exhaustively investigated, including both adult and embryonic sources of tissue.

Chapter 6|Table of Contents|Chapter 8

Historical content: June 17, 2001

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7. Stem Cells and Diabetes | stemcells.nih.gov

At Scott Medical Center, non-invasive medical procedures are the mainstay of our practice. Using the most up to date techniques, our staff treats patients as whole people, providing a comprehensive diagnostic assessment in order to design a customized strategy for relief from medical concerns. Stemcell research, for example, has advanced to a point that, at Scott Medical Center, stemcell injections as part of our array of treatments, designed to help our patients attain their wellness goals and achieve a higher quality of life.

For instance, until recently, treatment options for people with osteoarthritis of the knee were limited. Steroid injections, joint replacement surgery, and physical therapy were often the only treatment options. Now, stemcell injections for knee osteoarthritis are available, at Scott Medical Center. Stemcell therapy also has applications for treating Achilles tendonitis, rotator cuff tendonitis, and degenerative arthritis.

Stemcell injections work with the bodys natural ability to heal itself. Unlike treatments that simply address the symptoms, stemcell therapy actually promotes repair of the body, restoring degenerated tissue. Stemcell injections also contain hyaluronan, which eases pain and restores mobility by lubricating joints and tendons. This therapy fits well with Scott Medical Centers integrated approach to wellness, addressing the source of issues, rather than just treating the symptoms.

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Stem Cell Therapy - Scott Medical Center

The members of the Department of Microbiology, Biochemistry and Molecular Genetics at New Jersey Medical School of Rutgers Biomedical and Health Sciences (RBHS) are investigating some of the most intriguing problems facing modern biology, including regulation of gene expression, processing of mRNA, functional genomics, chromosome replication and recombination, regulation of cell growth and tumorigenesis, signal transduction and mechanisms governing bacterial and viral pathogenesis. Many different experimental systems are utilized including bacteria, viruses, yeast, animal cells and protozoa. The department is fully equipped for modern molecular studies and has core facilities available through the medical school for nucleic acid and protein sequencing, cell imaging, mass spectroscopy, FACS and advanced data processing. In 2002, the department occupied the newly constructed International Center for Public Health, which it shares with the renowned Public Health Research Institute Center of NJMS (formerly of New York City) and the NJMS - Global Tuberculosis Institute. The center creates a unique and exciting environment for scientific research.

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Yes No Cancer Type:Date Cancer Diagnosed:Month January February March April May June July August September October November December Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Year 1900 1901 1902 1903 1904 1905 1906 1907 1908 1909 1910 1911 1912 1913 1914 1915 1916 1917 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 1963 1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Cancer Status:Subject History: DiabetesAre You Diabetic?Taking Insulin?Subject History: Neurological SystemVision Decrease?Vision Black Spots?Vision Nistagmus?Muscle Weakness?Muscle Wasting?Walking Difficulties?Decreased Hand Strength?Fainting?Speech Problems?Tingling Sensation?Muscle Fasciculations?Spasticity?Hyperreflexia?Hyporeflexia?Depression?Loss of Memory?Headaches?Sleep Disturbances?Dizziness?Subject History: Pulmonary SystemAsthma?Chronic Bronchitis?Chronic Cough?Emphysema?Tuberculosis?Subject History: Cardiovascular ProblemsMyocardial Infarction?Myocardial Infarction Date:Month January February March April May June July August September October November December Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Year 1900 1901 1902 1903 1904 1905 1906 1907 1908 1909 1910 1911 1912 1913 1914 1915 1916 1917 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 1963 1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Angina Pectoris?Tachycardia?By-Pass Surgery?By-Pass Surgery Date:Month January February March April May June July August September October November December Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Year 1900 1901 1902 1903 1904 1905 1906 1907 1908 1909 1910 1911 1912 1913 1914 1915 1916 1917 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 1963 1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Hypertension (high blood pressure)?Hypotension (low blood pressure)?Subject History: CirculatoryPoor Arterial Circulation?Poor Venous Circulation?Leg Cramps?Tired Legs?Swollen Ankles?Varicose Veins?Tingling Sensation in Arms and Legs?Falling Asleep of the Hands and Legs?*Ulcers or open wounds anywhere on your body? Yes No Subject History: Gastrointestinal ProblemsAcid Indigestion?Bloating?Stomach or Duodenal Ulcer?Stomach or Duodenal Ulcer Date:Month January February March April May June July August September October November December Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Year 1900 1901 1902 1903 1904 1905 1906 1907 1908 1909 1910 1911 1912 1913 1914 1915 1916 1917 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 1963 1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Loss of Appetite?Rapid Weight Gain?Rapid Weight Loss?Overweight Problem?Have You Had Upper GI endoscopy?Upper GI Date:Month January February March April May June July August September October November December Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Year 1900 1901 1902 1903 1904 1905 1906 1907 1908 1909 1910 1911 1912 1913 1914 1915 1916 1917 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 1963 1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Upper GI Results:Hepatitis?Hepatitis Type:Gall Bladder Problems?Gall Stones?Icterus?Recurring Diarrhea?Subject History: Upper Respiratory Test*Chronic Sinusitis? Yes No *Allergic Sinus Problem? Yes No *Chronic Allergic Rhinitis? Yes No *Sinus Headaches? Yes No *Chronic Nose Bleeds? Yes No *Chronic Colds? Yes No Subject History: Rheumatic ScreenSoft Tissue Rheumatism?Articular Rheumatism?Joint Pain?Back Pain?Rheumatoid Arthritis?Other Rheumatic Conditions:Subject History: Endocrinological SystemDiabetes Mellitus?Overactive Thyroid?Underactive Thyroid?Adrenal Gland Dysfunction?Female Menopause?Male Menopause?Other Endocrinological Conditions:Health History Allergy:*Food Allergy, Especially Eggs? Yes No *Hay Fever? Yes No *Allergic Asthma? Yes No *Medication Allergies? Yes No Medication Allergy Symptoms:*Allergies to any vaccinations? Yes No Subject History: OtherWhen was your last vaccination?Month January February March April May June July August September October November December Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Year 1900 1901 1902 1903 1904 1905 1906 1907 1908 1909 1910 1911 1912 1913 1914 1915 1916 1917 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 1963 1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 *Do You Smoke Cigarettes? Yes No *Do You Smoke Cigars? Yes No *Do You Smoke Pipes? Yes No How Much Do You Smoke Per Day?*Do you drink wine? Yes No *Do you drink beer? Yes No *Do you drink hard liquor? Yes No How much do you typically drink per day?*Please list any nutritional supplements you are taking:Other Significant Illnesses:Do You Take Human Growth Hormone?How Long Have You Taken Growth Hormone?Human Growth Hormone Injections per Week:PSA Test (Men Only)?PSA Test Date:Month January February March April May June July August September October November December Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Year 1900 1901 1902 1903 1904 1905 1906 1907 1908 1909 1910 1911 1912 1913 1914 1915 1916 1917 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 1963 1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 PSA Test Result:Periodic Mammograms

(Women only)?

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Stem Cell Therapy || Treatment Application || Stem Cell ...

August 29,2017

Find resources you need or learn how you can help those affected by the devastation of Hurricanes Irma and Harvey, and wildfires in the western United States.

August 31,2017

The funds will beused for veterinary disaster reimbursementgrants administered by the American Veterinary Medical Foundation (AVMF).

October 15,2017

Storm impacts small and large animals, urban and rural clinicsBy Katie BurnsPosted Sept. 8, 2017

October 01,2017

Posted Sept. 13, 2017Signs of screwworm infestation were reportedly seen in Florida wildlife and d

October 01,2017

AVMA Convention attendees keep up-to-date with CE and friendsBy Malinda LarkinPosted Sept. 13,

October 01,2017

By Susan C. KahlerPosted Sept. 13, 2017 In his line of work as owner of Compassionate Veterinary

October 01,2017

Posted Sept. 13, 2017Featured are highlights from AVMA Convention 2017 in Indianapolis, where

October 01,2017

Associations for veterinarians, pharmacists working to reduce conflictsBy Greg CimaPosted Sept.

October 01,2017

Posted Sept. 13, 2017 On Aug. 24, Harvey intensified into a hurricane in the Gulf of Mexico. The s

October 01,2017

SAVMA meeting features leadership panel, increased grant fundingBy Malinda LarkinPosted Sept. 1

October 01,2017

Posted Sept. 13, 2017The AVMA Council on Education has scheduled site visits to five schools and c

October 01,2017

States encouraged to beef up wellness resourcesBy Malinda LarkinPosted Sept. 13, 2017 Drs. An

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such de-identified material to be exempted from its coverage (Clayton et al., 1995; Clayton, 1995; Bradburn, 2001; OHRP, 2004; Clayton, 2004).

While the de-identification may clear the institution of any obligations under HIPAA or the need for an IRB-approved informed consent procedure, Clayton (2004) explains that public opinion is different, and that most patients still believe they should be informed of all potential research uses of their biological materials and retain some autonomy over their use. Thus, she concludes that research institutions would be best served by working with patients collectively and individually to ensure appropriate oversight.

REFERENCES

Black N. 2003. Secondary use of personal data for health and health services research: Why identifiable data are essential. Journal of Health Services Research Policy. 8(S1):3640.

Bradburn NM. 2001. Medical privacy and research. Journal of Legal Studies 30(2):687701.

Burgess MM, Laberge CM, Knoppers BM. 1998. Bioethics for clinicians. 14. Ethics and genetics in medicine. Canadian Medical Association Journal 158(10):13091313.

Clayton EW. 1995. Why the use of anonymous samples for research matters. Journal of Law, Medicine and Ethics 23(4):375377.

Clayton EW. 2004. So what are we going to do about research using clinical information and samples? IRB 26(6):1415.

Clayton EW, Steinberg KK, Khoury MJ, Thomson E, Andrews L, Kahn MJ, Kopelman LM, Weiss JO. 1995. Informed consent for genetic research on stored tissue samples. Journal of the American Medical Association 274(22):17861792.

FDA (Food and Drug Administration). 2004. Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. Final rule. Federal Register 69(101): 2978529834.

Fernandez CV, Gordon K, Van den Hof M, Taweel S, Baylis F. 2003. Knowledge and attitudes of pregnant women with regard to collection, testing and banking of cord blood stem cells. Canadian Medical Association Journal 168(6):695698.

Fernandez MN. 1998. Eurocord position on ethical and legal issues involved in cord blood transplantation. Bone Marrow Transplantation 22(Suppl. 1):S84S85.

Gluckman E. 2000. Ethical and legal aspects of placental/cord blood banking and transplant. Hematology Journal 1(1):6769.

Haley NR. 1999. Linking donors to stored cord blood units: Duties to donors and recipients. Cancer Research Therapy and Control 8(4):345346.

HHS (U.S. Department of Health and Human Services Office for Civil Rights). December 3, 2002, revised April 3, 2003. General Overview of Standards for Privacy of Individually Identifiable Health Information. [Online] Available: http://www.hipaadvisory.com/regs/finalprivacymod/goverview.htm [accessed March 2005].

HHS. 2003. Privacy and Your Health Information. [Online] Available: http://www.hhs.gov/ocr/hipaa/consumer_summary.pdf [accessed March 2005].

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5 Ethical and Legal Issues | Cord Blood: Establishing a ...

NIH-supported pharmacogenomics researchers are making steady progress towards understanding how genes influence drug responses. These findings will improve doctors ability to personalize treatment by predicting an individuals response to a drug regimen and pre-empting problems, promising a future of:

Instead of basing a starting dose only on characteristics like weight and age, doctors will use a patients genetic profile to determine the best drug and the optimal dose.

Pharmaceutical companies will be able to develop and market drugs for people with specific genetic profiles. Testing a drug candidate only in those likely to benefit from it could streamline clinical trials and speed the process of getting a drug to market.

Doctors will be able to prescribe the right dose of the right medicine the first time for everyone. This means that patients would receive medicines that are safer and more effective for them, speeding recovery, avoiding adverse reactions, and improving health care overall.

Contact: Office of Communications and Public Liaison National Institute of General Medical Sciences info@nigms.nih.gov 301-496-7301

http://www.nigms.nih.gov

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NIH Fact Sheets - From Genes to Personalized Medicines

Certain foods may be helpful for boosting theimmune system and preventingcolds and the flu. Here's a look at five types of foods that provide nutrients that your immune system needs to perform:

An essential nutrient, vitamin C acts as an antioxidant. Antioxidants help fight free radicals, a type of unstable molecule known to damage the immune system. There's some evidence that vitamin C may be particularly helpful in boosting the immune systems of people under major stress.

To increase your vitamin C intake, add these foods to your diet:

Like vitamin C, vitamin E is a powerful antioxidant. Research suggests maintaining ample levels of vitamin E is crucial for maintaining a healthy immune system, especially among older people. To get your fill of vitamin E, look to these foods:

Zinc is an essential mineral involved in the production of certain immune cells. The National Institutes of Health (NIH) caution that even mildly low levels of zinc may impair your immune function. Here are some top food sources of zinc:

Another type of antioxidant, carotenoids are a class of pigments found naturally in a number of plants.

When consumed, carotenoids are converted into vitamin A (a nutrient that helps regulate the immune system). Look to these foods to boost your carotenoids:

Omega-3 fatty acids are a type of essential fatty acid known to suppress inflammation and keep the immune system in check.

Although it's not known whether omega-3s can help fight off infections (such as the common cold), research suggests that omega-3s can protect against immune system disorders like Crohn's disease, ulcerative colitis, and rheumatoid arthritis. Try these omega-3-rich foods:

To keep your immune system healthy, it's important to get sufficient sleep, exercise regularly, and manage your stress.

Although supplements containing high doses of antioxidants and other nutrients found in whole foods are often touted as natural immune-boosters, some research indicates that taking dietary supplements may have limited benefits for the immune system. (If you're still considering taking them, it's a good idea to consult your healthcare provider first to weigh the pros and cons.)

For more foods that may help boost your immune system, try adding garlic, foods high inprobiotics(such as yogurt and kefir), and green tea to your diet.

Sources:

Chew BP, Park JS. Carotenoid action on the immune response. J Nutr. 2004 Jan;134(1):257S-261S.

Gill H, Prasad J. Probiotics, immunomodulation, and health benefits. Adv Exp Med Biol. 2008;606:423-54.

Hughes DA. Effects of dietary antioxidants on the immune function of middle-aged adults. Proc Nutr Soc. 1999 Feb;58(1):79-84.

Kyo E, Uda N, Kasuga S, Itakura Y. Immunomodulatory effects of aged garlic extract. J Nutr. 2001 Mar;131(3s):1075S-9S.

Simopoulos AP. Omega-3 fatty acids in inflammation and autoimmune diseases. J Am Coll Nutr. 2002 Dec;21(6):495-505.

Wintergerst ES, Maggini S, Hornig DH. Immune-enhancing role of vitamin C and zinc and effect on clinical conditions. Ann Nutr Metab. 2006;50(2):85-94.

Disclaimer: The information contained on this site is intended for educational purposes only and is not a substitute for advice, diagnosis or treatment by a licensed physician. It is not meant to cover all possible precautions, drug interactions, circumstances or adverse effects. You should seek prompt medical care for any health issues and consult your doctor before using alternative medicine or making a change to your regimen.

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Foods That Help Your Immune System - 5 Types to Try

In a first survey, the project team recruited over 6,100 subjects from a catchment area including four towns in east-central Sardinia and assessed a first list of >200 traits. The baseline survey has been followed by follow-up visits that collected longitudinal data on the same traits collected at baseline but added assessment of frailty-related traits, namely measures of bone density and geometry, muscle strength, and gait speed, and additional cardiovascular measures (see below). In the course of SardiNIA3, along with the expansion of the cohort and the addition of more traits (see below), increases in testing efficiency and additional cost-sharing funds from Sardinian sources permit the completion of Fourth Visits for the entire cohort. Also in current actions, DNA sequencing has recovered essentially all of the genetic variation in the cohort, and further arrangements for an Outcome Study have also been made to be implemented in SardiNIA4, a further 5-year continuation of the Project that also projects Fifth Visits for the cohort.

The infrastructure for the clinic and phenotypic testing has been stable, with stringent quality control, which is reflected in the high quality of the database. The initial sample cohort included over 62% of the eligible population living in the region (age 14-102 years), and at least 96% of the initial cohort have all grandparents born in the same province. The initial group included 4,933 phenotyped sib pairs, 4,266 phenotyped parent-child pairs, >4,069 phenotyped cousin pairs, and >6,459 phenotyped avuncular pairs. Additional recruitment has increased the cohort substantially, and results have consistently shown that for essentially every trait, most of the associated genes and variants would be involved in determining variance in both young and old and in men and women. Thus, genetic analyses can draw on data from all ages and both genders.

The added value of studying a founder population has also been demonstrated by the extension of DNA analysis to the full range of variation by sequencing. The population has proven to contain the great bulk of variation found in other populations, but during its isolation over many thousands of years, many variants rare elsewhere have risen to relatively high levels on the island by drift or selection and others have newly arisen as Sardinian-specific. These have provided extensive new information about a whole range of traits and pathways (e.g., Nature Genetics November, 2015 articles and Editorial).

Sardinia also offers a special entre to the genetics of specific diseases that are especially prevalent in the founder population. This includes the anomalously high incidence of autoimmune diseases including Multiple Sclerosis and Type 1 diabetes, which interrupt the high to low gradient of incidence from Northern to Southern Europe. Again, this has fostered novel findings in causation and pathophysiology.

The founder population itself also contains within its DNA a record of human demography through history, which has permitted the inference of the timing of human population movements based on mitochondrial and Y chromosome analyses.

Regarding the course and mechanism of aging, the longitudinal study, now in its 15th year, focuses on residents of the cluster of towns to collect longitudinal information on more than 400 age-related quantitative traits ("endophenotypes" or "quantitative risk-related genetic or environmental factors") that can be scored on a continuous scale, as well as >200 dichotomous traits (including major diseases and risk factors such as smoking). The use of quantitative traits permits the study of the entire range of allelic variation in a population, with particular interest in a range of cardiovascular risk factors, anthropometric measurements, blood test values, facets of personality, and bone-density and frailty-related variables.

The longitudinal study of a broad range of phenotypes in a founder population is distinctive in this study, and stable environmental/epidemiological factors combined with the simplification of genetic analyses also aid in proposed joint investigations of relative risk. Furthermore, because we are collecting risk factor data, we can also analyze, in an Outcome Study, the prognostic power and/or pathophysiological relevance of earlier predictors for the onset of serious risk factors [e.g., increases in pulse wave velocity as a function of earlier (predictor) lipid and inflammatory markers].

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National Institutes of Health - SardiNIA

This information is intended for general information only and should not be considered as medical advice on the part of Health-Tourism.com. Any decision on medical treatments, after-care or recovery should be done solely upon proper consultation and advice of a qualified physician.

Stem cell cancer treatment

Stem cell cancer treatment is a type of treatment that treats cancer by using stem cell transplant, which is also called peripheral blood stem cell transplant. It is used to try and cure some types of cancer such as myeloma, lymphoma and leukemia. Stem cells are very early blood cells in the bone marrow that develop into red blood cells, white blood cells and platelets. They are needed in order to survive. Your doctor can collect them from a donor or from your blood. After a high dose of treatment which leaves stem cells dead, the stem cells are replaced through an intravenous drip.

Stem cell transplant infuses healthy stem cells into the body to stimulate bone marrow growth, suppress the disease and reduce the possibility of going into remission. Stem cell transplant implies that you can have higher doses of treatment through chemotherapy and radiotherapy. Therefore, the chances of getting cured are higher.

There are two main types of stem cell transplants. You and your doctor will discuss the best choice for you.

This is also known as auto stem cell transplant. Cancer treatment using autologous stem cell transplant uses your own stem cells. It is used mainly to treat myeloma and lymphoma. There is less risk of rejection or graft-versus-host disease, whereby the new donor cells think your cells are foreign and attack them. Ina addition, engraftment is quicker ad side effects are fewer.

How It Works: Your team of doctors collect, freeze and store your own stem cells. You then undergo treatment with chemotherapy or radiation therapy after which your stem cells are thawed and transplanted back into you. You may need to go through the above process twice instead of once. This is known as a tandem or double autologous stem cell transplant.

This type of stem cell transplant is also known as allo stem cell transplant. It involves using stem cells that have been donated. It is mainly used to treat leukemia, aggressive lymphomas and autologous transplants that have failed.

How It Works: Stem cells are donated from a matched donor. You then receive treatment using chemotherapy or radiation therapy after which you receive the donor stem cells.

The type and strength of your high-dose treatment is what will influence any side effects you may have and their severity. Possible side effects include:

After having a stem cell transplant to treat your cancer, you will have regular tests to check your general health. In addition, monitoring the levels of your blood cells, you will have blood tests. Most of the side effects are worse when your blood count is at its lowest. However, as this goes up, the side effects will begin to improve. You will be able to go home when your blood count has reached a safe level.

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Stem Cell Cancer Treatment in Panama - health-tourism.com

Acupuncture

Acupuncture is a technique in which practitioners stimulate specific points on the body - most often by inserting thin needles through the skin. It is one of the most effective practices used in traditional Chinese medicine. Acupuncture stimulates nerve fibers to transmit signals to the spinal cord and brain, activating the bodys central nervous system. The spinal cord and brain then release hormones responsible for making us feel less pain while improving overall health. Acupuncture may also: increase blood circulation and body temperature, affect white blood cell activity (responsible for our immune function), reduce cholesterol and triglyceride levels, and regulate blood sugar levels.

Aquatherapy

Aquatic Physical Therapy is the practice of physical therapy in a specifically designed water pool with a therapist. The unique properties of the aquatic environment enhance interventions for patients with neurological or musculoskeletal conditions. Aquatic therapy includes a wide range of techniques allowing patients to improve their balance, muscle strength and body mechanics. Aquatic therapy works to enhance the rehabilitation process and support effectiveness of stem cell treatment.

Epidural Stimulation

Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy (HBOT) is the medical use of oxygen at a level higher than atmospheric pressure. The equipment required consists of pressure chamber, which may be of rigid or flexible construction, and a means of delivering 100% oxygen into the respiratory system. Published research shows that HBOT increases the lifespan of stem cells after injection and provides an oxygen-rich atmosphere for the body to function at optimum levels.

Nerve Growth Factor (NGF)

Nerve growth factor (NGF) is a member of the neurotrophic factor (neurotrophin, NTFS) family, which can prevent the death of nerve cells and has many features of typical neurotransmitter molecules. NGF plays an important role in the development and growth of nerve cells. NGF is synthesized and secreted by tissues (corneal epithelial, endothelial, and corneal stromal cells), and it can be up-taken by sympathetic or sensory nerve endings and then transported to be stored in neuronal cell bodies where it can promote the growth and differentiation of nerve cells.NGF can exert neurotrophic effects on injured nerves and promote neurogenesis (the process of generating neurons from stem cells) that is closely related to the development and functional maintenance and repair of the central nervous system. It is also capable of promoting the regeneration of injured neurons in the peripheral nervous system, improving the pathology of neurons and protecting the nerves against hypoxia (lack of oxygen)/ischemia (lack of blood supply).

Nutrition Therapy

Occupational Therapy

Occupational therapy interventions focus on adapting the environment, modifying the task and teaching the skill, in order to increase participation in and performance of daily activities, particularly those that are meaningful to the patient with physical, mental, or cognitive disorders. Our Occupational Therapists also focus much of their work on identifying and eliminating environmental barriers to independence and participation in daily activities, similar to everyday life.

Physiotherapy

Physical therapy or physiotherapy (often abbreviated to PT) is a physical medicine and rehabilitation specialty that, by using mechanical force and movements, remediates impairments and promotes mobility, function, and quality of life through examination, diagnosis, prognosis, and physical intervention. We combine our PT with stem cells for maximum physical rehabilitation improvements.

Transcranial Magnetic Stimulation

Research has shown that TMS can effectively treat symptoms of depression, anxiety, neurological pain, stroke, spinal cord injuries, autism and more. This procedure is very simple and noninvasive. During the procedure, a magnetic field generator or coil is placed near the head of the person receiving the treatment. The coil produces small electrical currents in the region of the brain just under the coil via electromagnetic induction. This electrical field causes a change in the transmembrane current of the neuron which leads to depolarization or hyperpolarization of the neuron and the firing of an action potential.

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Stem Cell Treatment for Optic Neuropathy

This information is intended for general information only and should not be considered as medical advice on the part of Health-Tourism.com. Any decision on medical treatments, after-care or recovery should be done solely upon proper consultation and advice of a qualified physician.

What is Alzheimers disease?

This is a complex disease which affects brain nerve cells. It is the most common cause of dementia and effective treatment is very difficult.

What causes Alzheimers is still unclear. However, researchers have found out that there is an abnormal buildup of certain proteins in the brains of Alzheimers patients. Amyloid-beta is an example of one such protein. It clumps together to form plaques. Tau is another example, and it gets twisted into protein tangles.

Scientists have a theory that the plaques prevent proper communication of the brain nerve cells. The tangles make it hard for the nerve cells to get the nutrients they require. As the disease progresses, the nerve cells begin to die. Because of this, Alzheimers is a neurodegenerative disease.

Currently, Alzheimers disease has no cure. Medications are used to temporarily alleviate the symptoms by improving the ability to manage regular activities or enhancing memory. Most of these medications are cholinesterase inhibitors and they are used to prevent the breakdown of acetylcholine (a natural substance in the brain), which carries the signals between the neurons.

These are cells that can multiply and increase themselves (self-renew). In addition, they can develop and transform into different types of specialist cells which can carry out a specific function.

Yes, stem cell therapy can be done severally. Current research indicates the strong possibility of a cumulative effect from multiple therapies.

After the stem cell therapy, the stem cells have to make their way into the area in need of repair and then have their effect. This process takes time and usually takes several weeks or months to see the desired effect.

Currently, no proven and effective stem cell treatment for this disease is available. However, research is underway which utilizes stem cell technology to investigate the causes and effects of the disease. It is expected that their findings will play a crucial role in finding new drugs and cell-based therapies in the future. Stem cell therapy may help Alzheimers patients who do not respond to drug treatment, want to limit their reliance on medication or want to try stem cell therapy before drug treatment. Even if healthy, neural stem cells are available and can be safely transplanted, they would have to achieve therapeutic benefits by:

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Stem Cell Therapy for Alzheimer's in South Africa

A new therapy changes the balance of osteoblasts (pictured here) and fat cells in the bone marrow, leading to stronger bones.

Science Picture Co/Science Source

By Emma YasinskiSep. 5, 2017 , 2:59 PM

A drug that can reverse diabetes and obesity in mice may have an unexpected benefit: strengthening bones. Experiments with a compound called TNP (2,4,6-trinitrophenol, which is also known as picric acid), which researchers often use to study obesity and diabetes, show that in mice the therapy can promote the formation of new bone. Thats in contrast to many diabetes drugs currently in wide use that leave patients bones weaker. If TNP has similar effects in humans, it may even be able to stimulate bone growth after fractures or prevent bone loss due to aging or disuse.

As more and more patients successfully manage diabetes with drugs that increase their insulin sensitivity, doctors and researchers have observed a serious problem: Thedrugs seem to decrease the activity of cells that produce bone, leaving patients prone to fractures and osteoporosis.

There are millions and millions of people that have osteoporosis [with or without diabetes], and it's not something we can cure, says Sean Morrison, a stem cell researcher at University of Texas Southwestern in Dallas. We need new agents that promote bone formation.

Morrison and his colleagues have shown that a high-fat diet causes mice to develop bones that contain more fat and less bone. The diet increased the levels of leptina hormone produced by fat cells that usually signals satiety in the brainin the bone marrow, which promoted the development of fat cells instead of bone cells. That suggests that nutrition has a direct effect on the balance of bone and fat in the bone marrow.

After reading Morrisons work, Siddaraju Boregowda, a stem cell researcher at the Scripps Research Institute in Jupiter, Florida, was reminded of genetically altered mice that dont gain body fat or develop diabetes, even when fed high-fat diets. He and his boss, stem cell researcher Donald Phinney, wondered whetherthose mice were also protected from the fattening of the bone marrow that accompanies a high-fat diet.

They contacted Anutosh Chakraborty, a molecular biologist who was studying such mice down the hall at Scripps at the time. The animals lack the gene for an enzyme called inositol hexakisphosphate kinase 1 (IP6K1), which is known to play a role in fat accumulation and insulin sensitivity. The scientists suspected that the lost enzyme might affect the animals' mesenchymal stem cells (MSCs)stem cells found in the bone marrow that are capable of developing into both thebone cells and fat cells that make up our skeletons. If too many fat cells develop, they take the place of bone cells, weakening the bone.

The researchers fed genetically altered and normal mice a high-fat diet for 8weeks. Not only did the genetically altered mice develop fewer fat cells than their normal counterparts, but their production of bone cells was higher than that of the normal mice, the team reported last month in Stem Cells.

The scientists then set out to see whetherthey could use a drug to achieve the same effect in normal mice. For 8weeks, they fed normal mice a high-fat diet and gave them daily injections of either TNP, a well-known IP6K1 inhibitor, or a placebo. When they analyzed the animals bones and marrow, they found that mice that had received TNP had significantly more bone cells, fewer fat cells, and greater overall bone area. The IP6K1 inhibitor apparently protected the mice from the detrimental effects of the high-fat diet.

The study provided thesurprising result that one new therapy currently being explored to lower insulin resistance promotes, rather than decreases, the formation of bone in mice, says DarwinProckop,a stem cell researcher at Texas A&M College of Medicine in Temple, who was not involved in the work.

The researchers still need to figure out how to deliver TNPs effects only to MSCs, instead of the entire body, given that it sometimes blocks other enzymes along with IP6K1. Inhibition of IP6K1 is a promising target for patients with both diabetes and obesity, Boregowda says. He says he and his colleagues are now enthusiastic about testing their findings in a wide range of bone-related diseases and disorders. It might even help heal broken bones, he speculates.

Phinney, on the other hand, is aiming even higher. He wonders whetherthe therapy could also be useful for space travel, because bones are especially vulnerable to deterioration in zero gravity. Its a whole new field of science and drug discovery.

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New therapy could protect diabetic bones - Science Magazine

APPLETON, Wisc. (WBAY) As stem cell therapy grows in popularity in Northeast Wisconsin, treatment is expanding beyond chronic pain in the knees, hips, back and shoulders.

A Green Bay man battling lung disease says stem cell therapy saved his life.

Ken Schiller has lived on oxygen for the past 12 years while suffering from COPD, emphysema and Agent Orange.

"Tried to get a lung transplant and they told me well, can't do it, you're too old," says Schiller.

Five years ago, doctors gave Schiller four years to live.

But now he's breathing a sigh of relief.

"I couldn't walk 15-feet nine months ago without stopping to rest for 3-5 minutes, now I can walk through the grocery store, can walk out of this building to the car, I don't have a big problem," says Schiller.

Schiller turned to stem cell therapy at Optimal Stem Cell & Wellness Institute in Appleton.

"Now we've really seen incredible results with lung disease, COPD, pulmonary fibrosis, emphysema, these patients have nowhere else to go," says Dr. Michael Johnson who runs the clinic.

Dr. Johnson says patients like Schiller begin with a platelet rich plasma treatment, followed by stem cell treatment using stem cells from their own body fat.

"We draw off the fat, adipose, spin it down, draw off the stem cells and IV it back into them, after one round of stem cell therapy they're already doing better, it usually takes two or three for severe cases," says Dr. Johnson.

Schiller just underwent his third treatment and says he has a new lease on life.

"Two weeks ago we went to Laughlin, Nevada for four days, took a plane and came back, I thought those days were over, but they're not," says Schiller.

While stem cell therapy is still not FDA approved, or covered by insurance, Dr. Johnson says his office is fielding around 100 calls a week.

"This is the future," says Dr. Johnson.

Read more:
Stem Cell Therapy Expands Beyond Chronic Pain - WBAY

CHENGDU, China, Sept. 7, 2017 /PRNewswire/ -- Aging and related diseases are problems we have to face. Recently, Dr. Y. James Kang, CEO/CSO of Revotek and a pathfinder in Regenerative Medicine, delivered a talk entitled "Transforming Disease-based Medication to Personalized Healthcare"at theTEDx event in Chengdu, China. He unveiled techniques that would improve the quality of life for 2 billion people worldwide.

Aging Population Syndrome and Disease-based Medication

Although it is not recognized, people who are over 60 years oldhave a lower quality oflife. This sounds rare but is really true. "Let me tell you what I heard from them, 'my doctor told me I need seven stents in my heart, but now I only put a couple and wait for a while to put them all,' and then they will talk about how to save money for future disease treatment," said Dr. Kang, "I call this aging population syndrome."

The syndrome results from the disease-based medication, or standard end-stage medication. Dr. Kang further explained, "A man, whose coronary arteries are 30% blocked with atherosclerosis plaque, might only be suggested by his doctor use bypass or vascular stents to reopen the vessel conduit when the plague further grows to the point leading to life threatening problem. Until then, he could take some statin drugs to slow down, but not to stop the plaque growth. This is disease-based medication." It is widely applied in today's medical practice but did not match well with patients' personalized problems.

Personalized Healthcare

Instead of spending rest of our life in drug-keeping, living a quality-maintained healthy life is our ultimate goal. The personalized healthcare is totally different from disease-based medication. It advocates solving personalized problems at an early stage to prevent the disease from deteriorating. Hence, transforming disease-based medication to personalized healthcare is highly demanded and closely related to our lives.

Regenerative medicine, the core of personalized healthcare, is capable of recovering the function of failing organs through integrated approaches including stem cells whichnaturally occur/stored in the human body and arecapable of repairing injured organs. When a body is injured, the injured tissue sends out signals, then the repair materials (stem cells) would respond and be recruited to the injury site for repair. Stem cells, the essence of personalized medicine, however,have not beenwell recognized until now.

DEVELOR

Stem cells are well known to almost everyone. However, their approved clinical applications are rare. Rather than inducing stem cells to a desired cell type before its induction into a patient,Dr. Kang's team created a brand-new approach of utilizing the stem cells, called "Destination-Engaged Vector Evolving Lineage Organ Regeneration (DEVELOR)". In brief, the core concept is to firstly maintain the stemness of stem cells during the culturing and proliferation procedures, and deliver anadequate number of cells to the injury site, which would orchestrate the behavior of stem cells by secreting regenerative signals.

How to use DEVELOR to repair the damaged organs? Dr. Kang's team isolated mesenchymal stem cells from 5 g fat tissue of rhesus monkeys, cultured and prepared to "Biosynsphere", a new type of bio-ink. Then, the bio-ink was stacked through the 3D bioprinter and covered with prosthetic vascular graft to form hybrid vascular graft, which was used to replace the susceptible sites of atherosclerosis, the abdominal aorta of donor monkey. One month post the surgery, the graft was integrated with the monkey's own abdominal aorta, and the structure and function of whichwere identical. Apart from this application, DEVELORhas also beenapplied to damaged organs with scar tissue, presented by Dr. Kang in his TEDx talk.

Dr. Kang's team simply develop a technique to rejuvenate the self-repair process which is orchestrated by the injured site itself. With this approach, disease-based medication could be transformed to personalized healthcare through regenerative medicine. Dr. Kang's team offered novel solutions to the present and future of aging and disease problems.

For more info, contact: rel="nofollow">contact@revotekco.cn

Related Links: https://www.youtube.com/watch?v=26ioUypNIKshttp://v.youku.com/v_show/id_XMjk3NDAxMTcxMg==.html?spm=a2h0k.8191407.0.0&from=s1.8-1-1.2

View original content with multimedia:http://www.prnewswire.com/news-releases/pathway-to-solve-aging-population-syndrome-new-hope-has-been-delivered-at-tedx-event-300515420.html

SOURCE Sichuan Revotek Co.,Ltd

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Pathway to Solve "Aging Population Syndrome", New Hope Has Been Delivered at TEDx Event - Markets Insider

Denise Grady & Sheila Kaplan | September 7, 2017 | New York Times

TheFood and Drug Administrationannounced a crackdown on dangerousstem cellclinicswhile at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field.

The agency reported actions against two large stem cell clinics and a biotech company, saying that it was critical to shut down unscrupulous actors

Federal marshals seized 500 doses of live Vaccinia virus vaccine forsmallpoxbelonging to StemImmune Inc., a San Diego firm that develops stem cell-based immunotherapies forcancer. The raid came after the F.D.A. learned that the vaccine was being used to create an unapproved stem cell product, a combination of excess amounts of vaccine and stem cells derived from body fat, which was then administered to cancer patients with potentially compromised immune systems.

StemImmune obtained at least some of the vaccine from the Centers for Disease Control and Prevention, according to Thomas Skinner, a C.D.C. spokesman.

Those enterprises put the entire field at risk, Dr. Gottlieb said. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:F.D.A. Cracks Down on Unscrupulous Stem Cell Clinics

Related Stories

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'Unscrupulous' stem cell clinics targeted in FDA crackdown - Genetic Literacy Project

Credit: Biotechnology Journal

An invention by Florida Institute of Technology's Shengyuan Yang was found to naturally narrow the spreading of stem cells and has the potential to induce and regulate their differentiation.

Using Yang's patented and patent-pending technology, stem cells were grown on microscopic glass balls immobilized in a gel medium. Unlike the well-spread stem cells grown on a two-dimensional surface, the stem cells on the glass balls were almost uniformly spindle-shaped . More interestingly, this surface-curvature-induced-restriction in cell spreading also induced the differentiation of the stem cells.

These findings imply that the curvature of a substrate, as provided by the glass balls, may be utilized and tuned for cell and tissue engineering.

The research was recently published in Biotechnology Journal.

Yang's team used glass balls with diameters ranging from 5 m to 4 mm. They found that the minimum diameter of a glass ball on which a human mesenchymal stem cell (hMSC) can attach and spread is 500 m. Their gene expression experiments revealed that the hMSCs growing on the glass balls with diameters of 1.1 mm and below were differentiating into fat cells without the addition of any differentiation induction media.

This means that surface curvatures of a substrate could potentially be designed and optimized to achieve or change a specific cell shape and function. And, due to the different sensitivities of different cell types to substrate curvatures, the particular curvature of a growth environment, such as glass balls of various sizes, may also be used to construct cell-sorting devices.

Based on the experimental findings, Yang has filed three patents to cover the applications of the concept of substrate curvature in sorting cells, in guiding stem cell differentiation, in directing cell attachment and spreading, and in inducing isotropic spreading of cells.

Some past studies have shown the role of geometrical cues in influencing the differentiations of stem cells on two-dimensional surfaces, but to date, the effects of substrates with defined-curvatures on the behaviors of stem cells are still missing. Yang said studies on the cellular responses to substrate curvature are necessary and critical for understanding the cellular behaviors in three-dimensional micromechanical environments and for designing effective and efficient three-dimensional micromechanical environments to control cell and tissue developments. With their unique class of curvature-defined substrates, micro glass ball embedded gels are able to systematically investigate the effects of substrate curvature on the behaviors of stem cells.

With this promising first published report, Yang's group will continue to systematically investigate the effects of substrate curvature on the behaviors of stem cells.

Explore further: Professor publishes on first-ever imaging of cells growing on spherical surfaces

More information: Sang Joo Lee et al, Substrate Curvature Restricts Spreading and Induces Differentiation of Human Mesenchymal Stem Cells, Biotechnology Journal (2017). DOI: 10.1002/biot.201700360

Originally posted here:
Curved substrates restrict spreading and induce differentiation of stem cells - Phys.Org

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Buy bayer levitra online - Can you take levitra with food - The Postcolonialist

Nobody knew that health care could be so complicated. President Donald Trump

I was shocked by the quote above from our president, who made thisstatement in February 2017, soon after being inaugurated. As you all know, this statement was followed by six months of political debate over the repeal and replacement of Obamacare, also known as the Affordable Care Act. Contrary to the presidents statement, virtually anyone that has any connection to the U.S. health-care system knows that it is extraordinarily complicated. Medical professionals, health-system employees, patients, suppliers, vendors, and the majority of the citizenry would clearly disagree with the presidents statement that nobody knew.

This past six months, I have debated with myself whether a column related to health-care reform would be of value. After considerable thought and reflection, I realized that the following column, originally published in the Rochester Business Journal in January 2005, was as relevant today as it was then. As you read the following, it will be clear that the health-care debate has been a subject in political football since the enactment of the Medicare and Medicaid programs in 1965. As you read, remember that I did not have to change one word of what I published in the column some 12 years ago.

January 2005 column

Our health-care cost crisis is of our own making. Before launching into my health-care solutions agenda, please be advised that my opinions are predicated on a foundation of irrefutable assumptions.

All people are created equalNo human being is immortalWe live in a capitalist, not socialist, economyEvery individual has a right to access health-care servicesSocioeconomic factors create inequality in wealth distributionHealth-care cost is of legitimate concernThe vocal majority rules in health-care decision-makingThere is no such thing as unanimous support for health-care policy decisions

With these baseline assumptions, allow me to articulate a 10-point program for improving the cost-effectiveness of our communitys health-care system. Even though I must admit a fiscal bias due to my profession, the quality of health care is of equal importance in addressing these potential solutions. Also, I never intend to run for political office, and these opinions will ensure that I could never be elected.

With all due respect to myriad interest groups and health-care lobbies, here is Archibalds Top 10 list, in David Letterman format, with no humor intended:

10. Controllable behaviors that negatively impact an individuals health should be reflected as an increased cost in insurance premiums. If I smoke two packs a day, I should pay more. Abuse of controllable behaviors costs more in life and automobile insurance, why not health care? Tobacco and alcohol companies, beware.

9. Tort reform and caps on personal injury, pain and suffering awards are a legislative requirement. Maine took the first step in what I hope will be a trend in limiting awards in the litigation area. One of the platform issues of the new administration that I agree with is tort reform.

8. Successful reform of the health-care legal system should allow providers to immediately reduce costs associated with defensive medicine. The costs of unnecessary visits, tests, and procedures ordered by service providers to reduce the potential risk of litigation total billions of dollars each year. And malpractice-insurance-premium decreases will be an ancillary benefit.

7. Reintroduce the consumers wallet into health-care access and decision-making. If an individual wants to access health-care services, there should be a direct cost to the consumer, subject to income limitations. The recent adoption of health-savings accounts as an incentive for employers and employees to take control of escalating health-care costs is a paradigm shift in our governments attitude towards health care. Health-care costs are virtually invisible to consumers, and a Wegmans vs. Tops price comparison would certainly affect costs. If you want proof, look at the declining cost trends for Lasik surgery procedures.

6. Reduce the level of administrative and regulatory compliance costs in health care. Depending upon the study, costs in these areas consume up to 26 percent of every health-care dollar. The potential savings are enormous.

5. Technology advancement is wonderful and our nations research industry is the finest in the world. However, technology advances frequently increase costs through obsolescence of existing equipment and the incremental cost to providers of adding the new technology. This area may be one of the most difficult to address since any control mechanism that limits new technology must be balanced with appropriate incentives for research initiatives.

4. Controls over the drug manufacturers and pharmaceutical suppliers must be established. The efficacy of drug therapies must be assessed. Blatant and excessive advertising by the pharmaceutical industry to a public that is largely not responsible for the drug cost must be reined in. The final three items on my list are the most controversial of all. If I havent lost your vote yet, I am confident that the Big Three will push you to pull another lever.

3. Health-care capacity must be addressed through a local community effort. The debate is not about either competition or cooperation but, as Deion Sanders once said, I want both. Health-care delivery in this country is largely controlled by local communities. Competition among service providers is an essential element of health-care cost and quality in every community. Leadership without bias is a necessity for success in this area.

2. Establishing standards for patients expectations of their right to access health care, both basic and advanced, is a necessity. The research discoveries on the near horizon from genetic mapping will create new opportunities and make obsolete existing equipment and facilities. Bioethical debate must address the essential question of, Who is entitled to what and at what cost?

1. End-of-life care must be addressed. We are making progress in this area with health-care proxies, palliative-care initiatives, and other planning processes. However, its staggering to know that the majority of your lifetime health-care costs will be spent in the last year of your life.

Health-care spending is approaching 15 percent of our gross domestic product. The baby boom generation, of which I am a proud member, is beginning to retire. The health-care issues we face as a community and a country are overwhelming.

As CEO of Excellus, the dominant insurer in our community, David Kleins piece in the Dec. 19, 2004, edition of the daily newspaper was of interest. He stated: A healthier community is fostered when its business leaders, physicians and other health service providers are included in the dialogue and when these professionals work in an environment that has its major health service and financing organizations working more cooperatively and with a focus on community benefit. While this quote is a mouthful of words, action in support of this philosophy is what is needed.

Each of us must look in the mirror. A realistic assessment of our mortality and myriad issues that must be addressed is imperative. True innovation and industry reform can be a reality in health care.

Ignoring the debate and compromise necessary will only make matters worse.

The only modification to the 2005 column is that health-care costs now represent 18 percent of our gross domestic product. It is truly fascinating to me how little has been accomplished in the past 12 years. We can only hope that the future will bring rational reforms that address each of the major issues discussed in my 2005 column.

Gerald J. Archibald, CPA, is a partner in charge of the management advisory services at The Bonadio Group. Contact him at (585) 381-1000, or email: garchibald@bonadio.com

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Health-Care Issues Remain - The Central New York Business Journal

Spain has licensed TiGenix NV's expanded Madrid plant paving the way for a potential European launch of Cx601, its cell therapy forthe Crohn's disease complications.

Belgium-based TiGenix announced it received the Spanish Medicines Agency (AEMPS) license this week, explaining the Madrid plant will provide capacity for production of its portfolio of cell therapies including the candidate cell therapy Cx601.

Chief technical officer Wilfried Dalemans said: We have now significantly increased our manufacturing capacity, a key step in the preparation for commercialization of Cx601 in Europe and in the further development of our pipeline.

Cx601 has been accepted for review by the European Medicines Agency (EMA) and Swissmedic, which began reviewing TiGenix dossier in June.

At the time the firm told us Takeda will take over responsibility for making the cell therapy from 2021 but did not provide additional details.

Manufacturing expansion

Cx601 is made from stem cells taken from donor adipose tissue. It is being developed for the treatment of complex perianal fistulas in patients with Crohns disease patients who do not otherwise respond to standard therapies.

The therapy is madein a 2-dimensional cell culture.

TiGenix expanded the Madrid facility with support from Japanese drug firm Takeda, which licensed rights to commercialize Cx601 outside the US.

In the US, TiGenix has hired Lonza to make Cx601.

In February, the Belgian biotech said Lonza is transferring manufacturing technologies to its facilities in the US, adding that the Swiss contractor is poised to begin making the product for clinical trials.

A TiGenix spokeswoman told us "Lonza will manufacture material for the global Phase 3 trial of Cx601 in the US at Lonzas cell therapy production facility in Walkersville, Maryland (US), and the GMP facility will support the potential initial European commercial roll out of Cx601."

She added that: "The expanded facility will also provide capacity for the manufacturing of other pipeline products under development by TiGenix, including Cx611, currently undergoing a Phase I/II trial in severe sepsis."

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Spain OKs TiGenix's bigger cell therapy plant as firm preps for Cx601 - BioPharma-Reporter.com