The U.S. company Stem Cell Therapy International Inc. (SCII) today announced that it has agreed to litigation settlement terms with both the U.S.-based company Histostem-USA, and with the S. Korean company known as Histostem-Korea.

The terms of the agreement are contingent upon the close of an SCII and Histostem-Korea merger, to be forthcoming within the month. Specifically, the litigation agreement is contingent upon SCII acquiring no less than 90% of the total fully diluted equity of Histostem-Korea at the close of the merger.

As stated in the press release, "For the consideration provided by Histostem-USA, including but not limited to a waiver of claims and a general release, Histostem-Korea and SCII have agreed to pay Histostem-USA $100,000 in cash, which will be divided into three equal payments over a two year period; and seven and one half percent (7.50%) of the fully diluted total outstanding shares of SCII common stock following the close of the merger between Histostem-Korea and SCII. The management of Stem Cell Therapy International Inc. will continue to finalize a new merger agreement between SCII and Histostem-Korea in the next fifteen days."

According to Andrew Norstrud, CFO of SCII, "Over the past year, it has been very challenging to make significant progress in operations, obtain the necessary financing to execute our global strategy, and complete the merger while we were waiting for the final resolution in the Histostem-Korea litigation. We appreciate all of the investors who have continued to support SCII, and we look forward to completing this merger and obtaining the necessary financing to enable us to accelerate our strategic initiatives in the near future."

As further stated in the press release, SCII "plans to leverage Histostem-Korea’s technology to be the state-of-the-art conduit for bringing Asian adult stem cells into the U.S. for clinical trials and the treatment of conditions on which Americans spend billions of dollars annually. This is predicated on successful clinical trial results by Histostem-Korea for Male Pattern Baldness, Buerger’s Disease and other conditions, whose repository of over 80,000 cord blood units has consistently met the rigorous standards of the Korean FDA. This has made Histostem-Korea the largest repository of cord blood in the world, and one of the first to actually profit from sales of its own stem cell-derived products."

Based in Tampa, Florida, SCII is a regenerative medicine company that is "devoted to the treatment of patients with stem cell transplantation therapy as well as providing the supplies of biological solutions containing new lines of stem cell products," as described on their website. As further described on the company’s website, SCII uses a type of adult stem cell procedure which they refer to simply as "stem cell transplantation (SCT)", which is based exclusively upon adult stem cells and which, as they explain, "is a surgical procedure that has been used successfully for 70+ years as a treatment of many diseases for which modern medicine has had no therapy, or in which state-of-the-art therapies stopped being effective. A documented 5 million patients have been so treated worldwide to date, evidenced by over 120,000 publications in MEDLINE (see www.nlm.nih.gov) amongst others. SCT is approved for use by the German authorities and the EU."

AmStem International, a wholly owned subsidiary of SCII, is based in Northern California where it specializes is "biotherapeutic and cosmetic stem cell products".

Founded in 2000 and based in Seoul, S. Korea, Histostem houses the largest repository of cord blood stem cells in the world, from which the company has already treated more than 500 patients. The company currently has 56 full-time employees and 28 part-time employees, and an intellectual property portfolio that consists of 5 patents that have already been granted and 6 patents applications that are still pending.

(Please see the related news article on this website, entitled, "Leading U.S. and S. Korean Stem Cell Companies Announce Merger", dated September 25, 2009).

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.

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."

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.

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.

The adult stem cell company Vitro Biopharma has announced pending patent applications on proprietary cell-based cancer therapies that are developed from human adult stem cells. Specifically, the therapies incorporate the natural properties of a specific type of adult stem cell known as mesenchymal stem cells (MSCs), a highly potent stem cell that is commonly found in bone marrow, adipose (fat) tissue and umbilical cord blood.

This new announcement for the use of MSCs in cell-based cancer therapies is believed to have wide-spread applications in the therapeutic treatment of certain types of cancer that are known to develop from a specialized set of cancer stem cells which are typically highly resistant to standard therapies such as chemotherapy and radiation. Among other forms of cancer, the glioblastoma tumors that are found in brain cancer would be an excellent candidate for treatment with Vitro’s new therapeutic approach. The novel cell-based therapies capitalize upon the natural tendency of MSCs to migrate to cancer stem cells, thereby utilizing the MSCs as a delivery mechanism to transport toxic agents that may selectively target and kill the cancer stem cells. Precisely toward such a goal, Vitro Biopharma currently has patent applications pending for their new proprietary adult stem cell therapies, for which the company is also actively pursuing strategic partnerships in the commercialization of these new therapeutic products. Vitro Biopharma currently has other related products that are already commercially available.

According to Dr. Pamela Rice, a member of Vitro’s scientific advisory board and an oncology researcher at the University of Colorado at Denver, "Cellular-mediated destruction of cancer stem cells represents a promising new avenue for the development of effective treatments that specifically target cancer stem cells. Vitro has developed an exciting portfolio of products to advance research in this field, which is one of the few approaches to show promise against intractable cancers such as most forms of brain cancer. Additionally, Vitro’s patent pending technology for cancer therapy represents an exciting and novel approach to the selective eradication of cancer stem cells that could usher in new promise in the fight against cancer."

Vitro Biopharma recently established a new manufacturing site in Golden, Colorado, comprised of both corporate as well as R&D facilities. Vitro’s commercial focus is on a series of products developed from MSCs and iPS (induced pluripotent stem) cells, as well as on cancer research that utilizes exclusively adult stem cells in the development of novel cancer therapies.

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.