Neuralstem Awarded Adult Stem Cell Patent

The company Neuralstem has announced today that it has been awarded a patent for its latest proprietary technology for an adult stem cell therapy that can be used in the treatment of neurological diseases.

Entitled "Transplantation of Human Neural Cells for Treatment of Neurodegenerative Conditions", the patent also covers manufacturing methods and procedures for future related products, and will be in effect through July of 2026.

According to founding president and CEO, Richard Garr, J.D., "We are gratified to add this important core technology patent to our portfolio. The transplantation of our neural stem cells to treat degenerative conditions of the nervous system is at the heart of Neuralstem’s mission."

Although Neuralstem already holds a number of other patents for embryonic stem cell methods and processes in animal models, the company’s human stem cell product does not involve embryonic stem cells but instead is based exclusively upon adult stem cells that are derived from human adult CNS tissue.

With corporate headquarters in Rockville, Maryland, Neuralstem was founded in 1996 by the current president and CEO, Richard Garr, J.D., along with Merrill Solomon. As stated on the company’s website, Neuralstem describes itself as "a biotherapeutics company utilizing its patented Human Neural Stem Cell technology", which "allows for the isolation of CNS (central nervous system) stem cells from tissue; the expansion in vitro of each cell up to a billion billion times (60 doublings), and the controlled differentiation of the cells into mature, physiologically relevant human neurons and glia."

(Please see the related news article on this website, entitled, "Adult Stem Cells Approved for ALS Clinical Trial", dated September 21, 2009).

Osiris Clinical Trial Results Challenge FDA Protocol

A number of media sources, including The New York Times, recently reported that Prochymal, the leading adult stem cell product manufactured by Osiris Therapeutics, has "failed" two late-stage clinical trials. The term "failed", however, is the direct result of a technicality in FDA definitions and requirements: namely, the FDA does not recognize subsets of patients who participate in clinical trials. In actuality, however, Prochymal yielded statistically significant, highly impressive data in the specific subset of patients to whom this novel therapy was targeted.

Currently under question are two clinical trials in which Prochymal was tested as a therapy for graft-versus-host disease (GvHD), and also for steroid-refractory GvHD. In the clinical trial for steroid-refractory GvHD, the patients who took Prochymal in combination with steroids were found to have a 45% overall response rate, which was less than the 46% response rate for those patients who took steroids in combination with a placebo.

In the other clinical trial, for regular, non-steroid-refractory GvHD, it was found that 35% of all patients who received Prochymal exhibited an improvement in the disease, which, when compared to the 30% of patients who improved in response to a placebo, is not statistically significant.

When one looks at specific subsets of patients within the clinical trials, however, the data are quite different. Specifically, for patients with a form of GvHD that targets the liver and gastrointestinal tract, there was, in fact, a statistically significant response rate in which dramatic improvements were observed. However, at this time the U.S. FDA (Food and Drug Administration) does not typically approve therapies that are found to benefit only specific subsets of patients. The Osiris clinical trial results therefore call into question the FDA rules, which many scientists and physicians believe should be updated and revised in this regard.

GvHD is a potentially fatal disease in which immune cells from transplanted bone marrow recognize the recipient’s body as foreign and attack it. Of all the various types and cases of GvHD, it is the liver, the gastrointestinal tract, and the skin which are most commonly affected. Not to recognize a subset of patients who show significant improvement specifically in the liver and the gastrointestinal tract, in direct response to Prochymal, is to ignore a therapy that could have the greatest benefit for the greatest number of people. It is just one more example, of many, of how the FDA’s outdated rules and regulations have no scientific applicability whatsoever to the new field of regenerative medicine. It is just one more instance that proves the urgent importance of revision and updating of FDA laws.

Until such a revision actually happens, however, FDA regulators – and therefore most members of the media – are calling the Prochymal trials a "failure". The critically important subset of patients who showed statistically significant improvement in their livers and gastrointestinal tracts, as a result of receiving Prochymal, might beg to differ, however.

In fact, 74% of patients in this particular subset achieved complete remission of the disease – an astonishing improvement. If complete remission in nearly three-fourths of all patients in a particular subset cannot be considered "statisticallly significant", nothing can. The fact that this particular "subset" of patients represents the largest group of patients with this particular disease, is also worthy of serious consideration. Still, however, as a matter of general policy, the FDA refuses to recognize patient subsets – and therefore complete remission of the disease in 74% of patients in this particular group is considered a "failure".

Additionally, in the trial for steroid-refractory GvHD, Prochymal was found to increase the survival rate in children from the usual 20% to 60%. The FDA won’t recognize that data either, and therefore this particular trial is also considered to be a "failure". Parents with children who suffer with this condition, and who could therefore benefit from Prochymal, should not be allowed to have Prochymal, according to the FDA.

Derived from allogeneic (in which the donor and recipient are not the same person) adult stem cells known as mesenchymal stem cells (MSCs) that are harvested from the bone marrow of healthy young adults and cultured in the laboratory, Prochymal is the flagship product of Osiris Therapeutics, the world’s leading adult stem cell company. With its powerful immunomodulatory properties, Prochymal has already been found in numerous other studies to reduce inflammation and regenerate damaged tissue, in addition to ameliorating the immune response.

According to Duane Nash, an analyst at Wedbush Morgan Securities, "Prochymal really is the company’s main platform, and if Prochymal doesn’t work here then people will worry that it will not work elsewhere." Whether or not Prochymal is judged to be a success or a failure, however, seems to depend more upon outdated FDA technicalities than upon actual patient improvement.

Currently Prochymal is also being evaluated in 5 other indications, which include Type I diabetes and acute myocardial infarction, among other maladies. In fact, this is not the first time that Prochymal has "failed" a study. In June of this year the product was expected to improve lung function in patients with COPD (chronic obstructive pulmonary disease), but again the greatest response was found only in a specific subset of patients. Additionally, in March of this year Prochymal was evaluated in a clinical trial of Crohn’s disease but the FDA halted the trial due to design flaws in the study. The trial has since been redesigned and is expected to resume later this year.

It has been estimated that approximately 4,000 people in the U.S. alone are diagnosed with GvHD each year. The market potential has been projected to be between $150 million and $250 million.

As an ABC News reporter commented, "The unmet medical need might also persuade the U.S. Food and Drug Administration to abandon its normal protocol and approve the drug based on an analysis of a subset of patients, even if it fails the main goal of its trial to show the required level of complete response and survival."

As JMP Securities analyst Charles Duncan further adds, "It is possible that if you have efficacy in a subset of patients that is meaningful, then the trial may be deemed a success. You may actually see the U.S. Food and Drug Administration approve it on the basis of a subset analysis," particularly in the case of the steroid-refractory GvHD patient population. According to Edward Tenthoff, analyst at Piper Jaffray, "We are more confident in the steroid refractory study because we really believe that these patients do not respond to steroids."

As the ABC News reporter additionally points out, "If approved in other indications, the drug could become a blockbuster, generating sales of more than a billion dollars." Mr. Nash agrees, adding, "The thought is that the other indications that Prochymal could work in could potentially bring in over a billion dollars a year."

As of June 30th of this year, Osiris reported $52 million in cash and investments, which is enough to fund operations through the initial commercialization of Prochymal.

Prochymal is the only stem cell product currently on the market which has been granted both Fast Track and Orphan status by both the U.S. FDA and the European Medicines Agency. The mesenchymal stem cells (MSCs) contained in Prochymal are obtained from the bone marrow of healthy adult donors and are specially formulated according to a proprietary process for intravenous infusion. Osiris is also developing another adult stem cell product, Chondrogen, which is currently in clinical trials for the treatment of osteoarthritis of the knee.

A leader in adult stem cell therapies, Osiris Therapeutics is focused on the development of products for the treatment of inflammatory, orthopedic and cardiovascular diseases. Osiris was founded in 1992, went public in 2006 and currently has 47 U.S. patents, each with one or more foreign counterparts. In November of last year, Osiris formed a strategic alliance with the biotech company Genzyme that was valued at over $1.3 billion. In 2007, the two companies were awarded a $224.7 million contract from the U.S. Department of Defense for the development of Prochymal in the treatment of radiation sickness.

Perhaps this recent discrepancy between dramatic patient improvement in Prochymal’s clinical trials and the FDA’s definitions of "success" or "failure" will inspire a re-evaluation at the FDA of its rules on patient subsets. In fact, perhaps this would be an excellent opportunity for the FDA to further re-evaluate the modern relevance and scientific justifiability – or, more correctly, the lack thereof – of its rules and regulations in general.

U.S. and Jordanian Stem Cell Companies Sign Agreement

Stemedica Cell Technologies announced today the signing of an agreement with the Jordanian Stem Cell Company. The five-year, multi-million-dollar deal includes the purchase of technology from Stemedica’s wholly-owned subsidiary, Stemedica International, S.A., for the development, testing and commercialization of adult stem cell products. The first clinical trial under the new agreement is expected to begin in early 2010.

Based in Lausanne, Switzerland, Stemedica International is a wholly owned subsidiary of Stemedica Cell Technologies, headquartered in San Diego. Both are specialty biopharmaceutical companies that manufacture adult stem cells and stem cell factors for preclinical and human clinical trials conducted at research institutions and hospitals.

Headquartered in Amman, the Jordanian Stem Cell Company is chaired by His Royal Highness, Prince Asem Bin Nayef.

The signing took place at the European Burns Association Congress in Lausanne, Switzerland and was attended by Sam Alkhass, CEO of the Jordanian Stem Cell Company, as well as several representatives of Stemedica who included Dr. Mark Tager of Stemedica’s dermatological operations; Dr. Alex Kharazi, vice president of Stemedica’s research and manufacturing; Dr. Riccardo Nisato, director of manufacturing and business development at Stemedica; and Dr. Frank Schuller, CEO of Stemedica International.

As Sam Alkhass stated, "We are delighted to be working with Stemedica International. Jordan has an excellent reputation as a provider of innovative and quality-driven medical treatment. It was fundamental to our company’s future, and Jordan’s reputation, that we find the best possible partner within the stem cell industry. We believe we have accomplished this objective by securing a long-term exclusive relationship with Stemedica International."

As Nikolai Tankovich, M.D., Ph.D., Stemedica’s president and chief medical officer and vice chairman of Stemedica International, added, "Stemedica International will be providing our state-of-the-art stem cell technology to the Jordanian Stem Cell Company and will actively support their development and implementation of a clinical trial for burns. We will work closely with the leadership of the Jordanian Stem Cell Company to secure all necessary governmental approvals for the clinical trial. The trial is anticipated to begin sometime in the first quarter of 2010."

According to Dr. Schuller, "This is an important day for Stemedica International. This is a real testament to the quality and integrity of our products and the experience, dedication and professionalism of our team."

Fat Cells More Easily Programmed into iPS Cells

Scientists at Stanford University School of Medicine have discovered that adult stem cells derived from adipose (fat) tissue are more easily and quickly reprogrammable into iPS (induced pluripotent stem) cells than are the more commonly used fibroblast (skin) cells. The finding provides a potential new application for the numerous liposuction procedures that are performed throughout the U.S. each year.

According to Michael Longaker, M.D., a professor of surgery at Stanford and coauthor of the study, "We’ve identified a great natural resource." Indeed, he refers to "liposuction leftovers" as "liquid gold". As cardiologist and senior author of the paper, Joseph Wu, M.D., Ph.D., adds, "Thirty to forty percent of adults in this country are obese. Not only can we start with a lot of cells, we can reprogram them much more efficiently. Fibroblasts, or skin cells, must be grown in the lab for 3 weeks or more before they can be reprogrammed. But these cells from fat are ready to go right away."

The scientists also found that adipose cells are convertible into iPS cells without the need for mouse-derived feeder cells, thereby eliminating the risk of cross-species contamination that would render the cells ineligible for human clinical use.

As a number of previous, independently conducted studies have already demonstrated, adult stem cells derived from adipose tissue are highly versatile, not only for their ability to differentiate into a wide variety of tissue types, but also for the rich and abundant supply of natural growth factors that are found in adipose tissue, which are essential for maintaining the potency of stem cells. Due to the ease with which adipose-derived adult stem cells can differentiate into bone, cartilage and muscle, these cells have already been routinely used in clinical veterinary therapies for years by companies such as Vet-Stem in the U.S. and VetCell in the U.K., both of whom have already repeatedly published detailed accounts of the therapeutic value of adipose-derived adult stem cells in the medical literature.

These latest findings represent a collaboration between the Lucile Packard Children’s Hospital, where Dr. Longaker is director of surgical research, and two Stanford institutes, namely Stanford’s Stem Cell Biology and Regenerative Medicine Institute, where Dr. Longaker is deputy director, and the Cardiovascular Institute of Stanford, where Dr. Wu is assistant professor of cardiology and radiology.

According to Dr. Ning Sun, who participated in the research at the Stem Cell and Regenerative Medicine Institute, and in reference to adipose-derived adult stem cells, "These cells are not as far along on the differentiation pathway, so they’re easier to back up to an earlier state. They are more embryonic-like than fibroblasts, which take more effort to reprogram."

Ordinarily, iPS cells are derived from fibroblasts via 4 genes that are used for the reprogramming and which are known as Yamanaka factors, named after Dr. Shinya Yamanaka who first developed the technique. Adipose-derived adult stem cells express higher levels of 2 of these 4 reprogramming genes, and when all 4 genes are added to the cells, Dr. Longaker and his colleagues discovered that only 0.01% of the fibroblast cells become iPS cells, whereas 0.2% of the fat cells become iPS cells, which represents a 20-fold improvement in the process.

As a Stanford representative explained in the initial press release, "The new iPS cells passed the standard tests for pluripotency: they formed tumors called teratomas when injected into immunocompromised mice, and they could differentiate into cells from the 3 main tissue types in the body, including neurons, muscle and gut epithelium." In other words, the newly derived cells are not yet ready for clinical use, since the formation of teratomas (tumors) remains a disqualifying trait, albeit a formal requirement of pluripotency, by definition.

Nevertheless, as Dr. Longaker explains, "The idea of reprogramming a cell from your body to become anything your body needs is very exciting. The field now needs to move forward in ways that the Food and Drug Administration would approve – with cells that can be efficiently reprogrammed without the risk of cross-species contamination – and Stanford is an ideal place for that to happen."

As Dr. Wu further adds, "Imagine if we could isolate fat cells from a patient with some type of congenital cardiac disease. We could then differentiate them into cardiac cells, study how they respond to different drugs or stimuli and see how they compare to normal cells. This would be a great advance."

Even though actual clinical therapies from iPS cells still remain years away, the discovery offers a new application for the endless supplies of liposuctioned fat – with its rich latticework of adipose cells, collagen and growth factors – which would otherwise normally be discarded as medical waste in countries such as the U.S, where it has been estimated that approximately two-thirds of the population, or approximately 200 million people, are overweight.

The Media is Criticized for Embryonic Stem Cell Bias

Not surprisingly, an organization that is focused on culture and the media issues a statement in which members of the U.S. media are criticized for their irresponsible bias in favor of embryonic stem cell research, while deliberately and systematically ignoring adult stem cell accomplishments.

According to Colleen Raezler of the Culture and Media Institute, reporter after reporter mistakenly features news that promotes embryonic stem cells as the ultimate cure for everything, despite the fact that embryonic stem cells have never been used to treat anything. Meanwhile, adult stem cells, which actually have been used to treat an increasing number of diseases and injuries, are routinely ignored by the media as a matter of policy.

Although this is a rather unsurprising statement of the obvious, its importance cannot be overemphasized. The unjustifiable, unconscienable and scientifically inaccurate bias throughout the media has the effect of misleading the public and creating false hope through unrealistic expectations. Even embryonic stem cell scientists themselves have tried to caution the public that clinical therapies from these cells are at least another decade away, if not more, yet there are very few members of the media who do not choose to turn a blind eye and a deaf ear to such expert advice. As Ms. Raezler further explains, members of the media are also "ignoring the fact that adult stem cell research has provided 73 different breakthroughs to help people with spinal cord injuries, Alzheimer’s disease, Parkinson’s disease, and diabetes," among other ailments.

Of course, no one would ever presume members of the media to be deliberately manipulative of the public. If they were, however – hypothetically, that is – they could not do a better job of misrepresenting the scientific truth than they currently are.

Hopefully, however, organizations such as the Culture and Media Institute will continue to challenge those members of the media who have chosen to relinquish their very serious responsibility to uphold and report the facts, and who instead consistently portray erroneous and unsubstantiated hyperbole as science.

Bioinformatics Company Launches Stem Cell Collaboration

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.

Stem Cell Company Hosts Training Courses

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.

Adult Stem Cell Clinical Findings Presented at European Conference

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.

Eastern European Stem Cell Symposium Hosts International Speakers

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.

Stemgent Sponsors Harvard Seminar Series

The biotech company Stemgent announced today that it has pledged a financial gift to the Harvard Stem Cell Institute (HSCI) for its 2009-2010 Seminar Series.

According to Ian Ratcliffe, president and CEO of Stemgent, "We’re pleased to be able to fund this prestigious seminar series and we’re very proud of our ongoing relationshipwith HSCI through our Scientific Advisory Board which includes Harvard’s Lee Rubin and Doug Melton. HSCI has a top-notch research team, displays a global scientific acumen and it’s always a great pleasure to work with them."

As Brock Reeve, executive director of HSCI, adds, "The HSCI Seminar Series is focused on enabling scientific interchange among experts in the stem cell field from around the world. HSCI is very pleased that Stemgent, a company focused on addressing the needs of stem cell scientists, has agreed to partner with us by supporting this series."

Founded in 2004, the HSCI consists of 72 principal faculty and 146 affiliate faculty, thereby constituting the world’s largest organization of stem cell researchers. The HSCI describes itself as "a scientific collaborative that brings together researchers from across Harvard’s many affiliated hospitals, institutes and schools."

The HSCI further describes its seminar series as "an educational program for the stem cell science community in which pioneers in the national and international realm of stem cell research, including many from the Harvard-affiliated senior faculty, present contemporary stem cell topics. Speakers are nominated by HSCI faculty and selected by the HSCI."

With dual headquarters in San Diego and Boston, Stemgent is focused on the commercialization of proprietary reagents and other tools that have been optimized for stem cell research, including transfection reagents, viral-delivered transcription factors, cytokines, antibodies and cell lines, among other small-molecule products.

The precise financial terms of the sponsorship were not disclosed.