The International Summer School for Stem Cells and Regenerative Medicine in Piran, Slovenia has just finished hosting an international panel of speakers from August 21st through the 29th. In addition to the formal conclusions drawn by the scientists during the week-long symposium, the mere list of topics which they addressed constitutes a revealing evaluation and excellent summarization of the field of regenerative medicine.

Among the sponsoring participants was the Florida-based U.S. company known as "Hard To Treat Diseases" (HTDS), whose medical director, Dr. Ivana Gadjanski, spoke at the symposium. Other speakers from the U.S. included Drs. Tanja Dominko and Raymond Page from the Worcester Polytechnic Institute in Massachusetts, and Dr. Darja Marolt from Columbia University in New York. Among the other speakers and countries represented were Dr. Stephen Minger from King’s College in London, Dr. Thomas Ekstrom from the Karolinska Institute in Stockholm, Sweden, Dr. Zoran Ivanovic from the blood bank EFS in Bordeaux, France, Dr. Smadar Cohen from the Ben-Gurion University of the Negev in Israel, and Dr. Dasa Cziskova from the Institute of Neurobiology in Kosice, Slovakia.

An excellent overview of the current state of affairs in the field of regenerative medicine can be gleaned by a quick glance at the topics that were addressed, which can be broadly divided into the following categories: 1) types of stem cells that are or are not suitable for clinical application, 2) ethical issues, 3) obstacles to therapy, 4) clinical trials, 5) technical issues pertaining to laboratory methods, 6) new ways of inducing pluripotency, 7) adult stem cells derived from umbilical cord blood, 8) adult stem cells derived from adipose tissue, and 9) means of enhancing endogenous stem cell activity. In the category of "obstacles to therapy", teratoma formation from any type of pluripotent stem cell was the dominant, most problematic concern. In the category of "clinical trials", the recent FDA-imposed halt on Geron’s embryonic stem cell trial was the focus of discussion. In regard to "technical issues pertaining to laboratory methods", topics of interest included the various types of biomaterials that are used for cellular scaffolds, the types of bioreactors that are used for growing cells, and the protocols for isolating cells from various tissues, among other themes. It is particularly noteworthy that both umbilical cord blood and adipose tissue received special attention as the most promising sources of the most versatile and the most clinically viable stem cells – all of which is indicative of the fact that gone are the days when stem cells were simplistically divided into the 2 fundamental categories of embryonic versus adult. Indeed, the only attention that embryonic stem cells received during this entire symposium was when the participants addressed the persistently recurring themes of teratoma formation and the types of stem cells that are unsuitable for clinical application. When it came to a discussion and analysis of clinically viable stem cells, only adult stem cells have proven to be qualified for this category, and people are now accustomed to drawing fine distinctions among the many different types of adult stem cells and their already very well elucidated characteristics.

The formal conclusion of the entire symposium, however, was that the most efficacious type of clinical therapy will be one that stimulates the powerful healing mechanisms of the body’s own naturally occurring supply of endogenous adult stem cells. Not only does this approach eliminate all ethical concerns and potential risks of immune rejection, but it has also proven to be among the most therapeutically efficacious of medical approaches.

The fact that this symposium was hosted by an Eastern European city, the name of which is unfamiliar to most Americans, is also not without its significance. Although there are some countries in the world, such as the U.S., who tend to think of themselves as the scientific center of the universe when it comes to stem cell research, in actuality there are many other countries which are advancing more rapidly in stem cell technology. Such a fact has nothing to do with Bush-era restrictions that were imposed on embryonic stem cell research, since embryonic stem cells are still ineligible for clinical use, even with unlimited funding, due to a number of dangers that they pose, not the least of which is teratoma (tumor) formation. Instead, the greatest hindrance to stem cell advancement in the U.S. is the entirely politically driven and egregiously unscientific insistence by the U.S. FDA that each person’s own endogenous adult stem cells must be classified as "drugs" and regulated as such. It is this unconscienable government policy – which persists throughout the Obama administration – that is driving the best, brightest and most capable U.S. clinics and doctors overseas, where they are setting up their offices in any and every other country on earth except the United States.

U.S. citizens should therefore be prepared to hear a lot more news throughout the future about impressive advances in adult stem cell therapies that are happening in places such as Piran, Slovenia.

This week in Barcelona, at the 10th annual congress of the European Society of Cardiology, the U.S. company TCA Celluar Therapy is presenting its latest clinical findings on its own proprietary adult stem cell therapies in the treatment of two particular diseases, namely, critical limb ischemia (CLI) and refractory coronary ischemia (CI). TCA has already evaluated its therapies for both conditions in U.S. FDA-approved clinical trials.

According to Gabriel Lasala, M.D., president, co-founder and medical director of TCA, TCA is the only company in the world currently utilizing two different types of adult stem cells to treat both cardiac and vascular conditions. Most recently, Dr. Lasala and the company’s scientific director, Dr. Jose Minguell, have together treated 33 patients for CLI in both Phase I and Phase II clinical trials in which patients were treated with a combination of autologous endothelial progenitor cells and mesenchymal stem cells harvested via bone marrow aspiration. The combined cells were then infused directly into areas of ischemic tissue and blood vessel damage, from which new, mature and stable vessels were observed to form via the natural angiogenic properties of these particular adult stem cells. No adverse side effects were observed in any of the patients, all of whom experienced "a progressive improvement in all clinical parameters which are still persisting a year after treatment," according to the researchers.

Similarly, in CI clinical trials, Drs. Lasala and Minguell completed a Phase I protocol last year and are currently conducting Phase II trials in which 60 patients have been enrolled. Thus far all patients have exhibited "a significant improvement in the quality of life", according to the doctors, with the results suggesting that "recruitment of new capillaries could be a leading event involved in the improvement of CI," as the researchers explain. According to Drs. Lasala and Minguell, this is the first safety and feasibility study that tests the infusion of this particular combination of adult stem cells.

As Dr. Lasala further describes, "All patients experienced improvement in their walking tests, ankle brachial pressure index, oxygen pressure, angiography and quality of life. The similarity in the recovery of our patients is promising. We find that the stem cells, once re-injected, go about forming new blood vessels, thus increasing circulation dramatically. These findings, coupled with increase of blood flow in collateral vessels, suggest that the therapy is both safe and effective."

Headquartered in Covington, Louisiana, TCA Cellular Therapy is currently participating in a number of FDA-approved clinical trials, all of which are testing novel adult stem cell therapies.

The biotech company Stemcell Technologies announced today the schedule for their fall training program. The new curriculum includes a number of 2-day courses, namely, on mesenchymal stem cell biology (October 2nd and 3rd), mammary stem cell biology (October 17th and 18th), neural stem cell biology (October 30th and 31st), hematopoietic stem cell biology (October 30th and 31st), and lastly, human embryonic stem cell and iPS (induced pluripotent stem) cell biology (November 14th and 15th). All courses will be held at the company’s Vancouver headquarters and will be taught by scientists who have been personally involved in the actual development of many of the research tools and techniques that are commonly employed in stem cell laboratories around the world today. Hands-on instruction will be emphasized, in conjunction with some lectures.

According to Dr. Chantal Proulx, technical support manager at Stemcell Technologies, "We are dedicated to providing standardized tools and reagents in order to advance research, but this is only half the story. Providing detailed training courses to standardize the techniques that people use to grow their cells is also a key part of the equation."

As described on their website, the biotech company Stemcell Technologies is involved in "the development and marketing of specialty cell culture media, cell separation products and ancillary reagents for life science research." Stemcell Technologies currently delivers more than 900 products to research scientists in over 70 countries worldwide.

Headquartered in Vancouver, British Columbia, Canada, Stemcell Technologies also has corporate offices in France, Germany, the U.K., Australia and Singapore.

Researchers who wish to register for the courses may apply directly with the company.

A leading manufacturer of bioinformatics software for systems biology and drug discovery, GeneGo announced today that it has launched a collaborative endeavor with global pharmaceutical companies and academic centers. Known as the MetaMiner Stem Cell Project, the 24-month-long collaboration has been designed to create a comprehensive knowledge base for the properties and characteristics of different types of stem cells. The knowledge base will then in turn be applied to experimental R&D for the therapeutic use of stem cells of various types.

According to Yuri Nikolsky, CEO of GeneGo, "We are really excited about this project. Although one of the hottest areas of life science, no systematic effort was done on methodical annotation of current experimental knowledge on stem cells, and we intend to fill this gap. Understanding the biology of embryonic, adult and neoplastic stem cells is key in both drug discovery and fundamental research in many fields from embryology and ontogenesis to cancer and diabetes."

Similarly, Julie Bryant, GeneGo’s vice president of business development, adds, "We are very glad to be able to attract an excellent team of members for the cause. An industry-academia consortium model fits well with our development objectives in such a complex and controversial field. We believe that the members will see a strong positive return on their investment within several months from the project’s launch."

As described on their website, GeneGo provides "data mining and analysis solutions in systems biology". The company is focused on the development of "systems biology technology, such as compound-based pathway analysis, cheminformatics and bioinformatics software for life science research. The original computational MetaDiscovery platform allows an integration and expert analysis of different kinds of experimental data (mRNA expression, proteomics, metabolomics, microRNA assays and other phenotypic data) and relevant bioactive chemistry (metabolites, drugs, other xenobiotics) within the framework of curated biological pathways and networks. GeneGo’s flagship product, MetaCore 5.4, assists pharmaceutical scientists in the areas of target selection and validation, data mining in biology, identification of biomarkers for disease states and toxicology. The second product, MetaDrug 5.4, is designed for prediction of human metabolism, toxicity and biological effects for novel small molecule compounds. MetaBase represents the knowledge base for MetaCore."

Founded in 2000 by Dr. Tatiana Nikolskaya, a molecular biologist from the University of Chicago, GeneGo is headquartered in St. Joseph, Michigan, with offices in San Diego and Moscow.

In the latest development of adult stem cell technology, doctors in England are pioneering a new technique in which autologous adult stem cells are used to repair damaged hips. The new procedure is already rendering conventional hip replacements unnecessary.

Having suffered from a painful weakening of his hip joint that was caused by avascular necrosis of the femural head (dead tissue in his leg bone at the hip joint), 39-year old Mark Venables became one of the first patients to undergo the new therapy, which was conducted at Spire Hospital in Southampton. Using adult stem cells that were harvested from bone marrow extracted from Mark’s pelvis, the doctors then mixed the stem cells with ground-up bone that had been derived from another patient. After removing the necrotic tissue from the ball of Mark’s hip, the doctors then filled the cavity with the new mixture.

As Dr. Doug Dunlop, who performed the procedure, explains, Mark’s bone eventually would have collapsed without the stem cell treatment. "If this new procedure works, he won’t need a hip replacement. It will fix his hip for life," according to Dr. Dunlop. As Mark himself stated prior to the operation, "I just want to get back to an active life." His rapid recovery would seem to indicate that he is on the road to doing exactly that.

Thus far 6 patients have received the treatment, 5 of whom have shown exceptionally rapid improvement. Although one of the 6 patients did not improve, no adverse side effects were reported in any of the patients. In the 5 of the 6 patients who did respond positively, improvement included the ability to walk normally again without any pain, and hip replacement surgery was no longer necessary. Prior to receiving the adult stem cell therapy, hip replacement surgery had been prescribed as necessary for all 6 of the patients.

Carl Millard, one of the patients who improved following the stem cell procedure, is now able to walk normally and without any pain. As he describes, "I feel great. If this can prevent people having to have a hip replacement, I think it’s wonderful."

Dr. Richard Oreffo of Southampton University has designed a further improvement upon the technique, in which an artificial material – containing all the right chemical growth factors for adult stem cells – would be used instead of donated, ground-up bone. As Dr. Oreffo explains, "Bone is a living vibrant tissue. These stem cells generate new tissue and drive new blood vessel formation to bring in nutrients. Just as people need cornflakes and sugar in the morning, so cells need nutrients to grow and survive – and that is what is so important here."

It has been estimated that approximately 30,000 knee replacements and 50,000 hip replacement operations are performed every year just in England and Wales alone. In larger countries, such as the U.S., the potential market is proportionately larger. By rendering conventional hip replacements obsolete, this new adult stem cell therapy promises to offer a highly preferable option to an increasing number of people who suffer from a wide variety of orthopedic problems. Indeed, as previously reported a number of times on this website, autologous adult stem cell therapy is transforming the entire field of orthopedic medicine, rendering most types of joint replacement surgery unnecessary. Such is the case not only for conditions of avascular necrosis, such as that featured herein, but also more generally for age-related osteoarthritis and degenerative joint diseases. No doubt the "orthopedic surgery" of the future will be vastly different from that of the past, and will most likely consist of pin-pointed injections of autologous adult stem cells rather than entire joint replacements.

Using ordinary skin cells derived from patients with Type I diabetes, scientists were able to reprogram the cells to create new cells that produce insulin. The announcement heralds a potentially revolutionary type of therapy for the millions of people who suffer from Type I diabetes.

In a procedure which is now commonly reproduced by stem cell scientists around the world, the researchers de-differentiated ordinary somatic (non-stem-cell) skin cells into a more primitive state, known as iPS (induced pluripotent stem) cells. In a new variaton on the theme, however, the iPS cells were then reprogrammed and re-differentiated into a new type of cell, one which resembles the insulin-producing beta islet cells of the pancreas. Specifically, the skin samples were obtained from two white males, one of whom had been diagnosed with Type I diabetes at 3 years of age, and the other of whom was first diagnosed at 21 years of age. Led by Dr. Douglas Melton, codirector of the Harvard Stem Cell Institute and a leading investigator at the Howard Hughes Medical Institute, the team of researchers reprogrammed the fibroblasts into iPS cells using 3 of the 4 genes that are commonly used for the iPS reprogramming procedure. Although the new cells do not produce insulin as efficiently as naturally occurring pancreatic cells do, nevertheless the new cells are responsive to changes in blood sugar levels. The procedure signifies an especially important accomplishment since the skin cells were not randomly taken from any donor but instead were specifically taken from patients who are suffering from Type I diabetes, thereby yielding a new type of cell which is "patient-specific" and which therefore matches the individual’s unique genetic profile, in addition to being free of any risk of immune rejection.

The next step now is to create an animal model of Type I diabetes in which the new cells can be studied. Eventually, the ultimate goal is to develop a clinical therapy from the procedure which can be used in human patients to replace the pancreatic beta islet cells that are destroyed by Type I diabetes.

According to Susan Solomon, J.D., CEO of the New York Stem Cell Foundation, which cofunded the study, "This is a big deal. Tackling the basic biology of Type 1 diabetes, which is a very complex disease, is a critical step. With these cells, we can see in a dish what’s happening to the immune system, and if you don’t understand the immune response, you get nowhere with Type 1 diabetes." As Dr. Meri Firpo of the Stem Cell Institute at the University of Minnesota further adds, "This is very preliminary data, but now we could potentially look at the interaction between immune system cells and insulin-producing cells to find the root cause or trigger, which we think might vary from patient to patient."

Meanwhile, however, such a therapy is still in the developmental stage, and the new insulin-producing cells are currently disqualified from clinical use since the genetic manipulation that is used for reprogramming the cells poses too many medical risks. Among other problems, cells from mice that have been reprogrammed according to this method have been found to develop into teratomas (tumors) when the cells were readministered to the mice. According to Julia Greenstein of the Juvenile Diabetes Research Foundation (JDRF), the most immediate applications of Dr. Melton’s new achievement "are primarily research-related". As she further explains, "Our hope is that understanding all of these things will come together – that once we’ve figured out how to make the cell source, we will have also figured out how to block the immune response, but there’s a lot of basic science one has to do to get there." Nevertheless, "There’s an incredible amount of exciting research that has the capacity to impact the disease in the long-term," she adds.

Believed to be of autoimmune origin, Type I diabetes destroys the insulin-producing beta islet cells of the pancreas. Though not as common as Type II diabetes, Type I diabetes is currently untreatable by conventional medical therapies, which offer no known cure for the disease. Since there is a strong genetic susceptibility, researchers believe that "patient-specific" therapies which are derived from each patient’s own unique cells should offer the most efficacious type of treatment. Such therapies would also eliminate any need for dangerous immunosuppressive drugs – if or when such therapies are ever actually developed from iPS cells, some day, at some undetermined point in the future.

Of course, "patient-specific" therapies already exist, today, and have already been derived from autologous adult stem cells and are already being used in clinics around the world for a wide variety of diseases and injuries, without any risk of immune rejection and without any need for dangerous immunosuppression – should anyone be interested to notice.