Two U.S. Adult Stem Cell Companies Form Collaboration in Asia

PRNewsWire.com, May 11, 2009

The adult stem cell storage company Neostem announced today that it has signed an exclusive licensing agreement with Regenerative Sciences for the commercialization of proprietary adult stem cell technology. The territory to which the licensing agreement applies is all of Asia.

Regenerative Sciences developed the technology, known as Regenexx, specifically for the treatment of orthopedic conditions. Regenexx is a minimally invasive outpatient procedure in which adult stem cells are extracted from a patient's own bone marrow, cultured in a medium containing important growth factors from the patient's own blood, expanded to millions of stem cells over a period of 2 to 3 weeks, and then readministered to the patient. Specifically, mesenchymal stem cells are derived from each patient's own bone marrow, and after processing the cells are injected directly into the patient's afflicted joints. Since the stem cells are autologous (in which the donor and recipient are the same person), there is no risk of immune rejection. The procedure has already been used to treat hundreds of patients, for whom the procedure has eliminated the need for surgery.

Regenerative Sciences will serve as a consultant to NeoStem throughout their commercialization of the technology in Asia. According to Dr. Robin Smith, CEO of NeoStem, "We are very pleased to obtain the exclusive license in Asia to Regenerative Sciences' unique technology, and we're delighted to establish this relationship with Dr. Centeno. The minimally invasive Regenexx procedure complements NeoStem's established in-office stem cell collection procedures and expands our expertise into a new area. Restoring joints, bone, muscle and cartilage and combating orthopedic diseases complements our growth in the anti-aging and regenerative medicine arena. Recently, we announced acquisition of an exclusive worldwide license for innovative stem cell technology and applications for cosmetic facial expansion procedures and skin rejuvenation. With Dr. Centeno's assistance we will be adding his stem cell expansion procedure for orthopedic regeneration to the services we are offering in Asia through prominent medical institutions with which we are partnering that we expect to come to market by the end of this year."

According to Dr. Christopher Centeno, founding CEO of Regenerative Sciences, "I look forward to working with Dr. Smith and her team at NeoStem to bring Regenerative Sciences' important stem cell innovations to a worldwide audience of doctors and patients. I'm especially excited about NeoStem's relationships and its expanding presence in China."

With their corporate headquarters in New York City and their laboratory banking facility in Los Angeles, NeoStem specializes in the collection, processing and long-term storage of adult stem cells for therapeutic use at a later time in the future, if and when such a therapy might be needed. NeoStem was the first company to provide adult stem cell collection and banking services to the general public.

Headquartered in Colorado, Regenerative Sciences first began performing the Regenexx joint and bone stem cell procedure in 2005. Since then, hundreds of patients have been able to avoid surgeries of the shoulder, knee and hip through the use of their own autologous adult stem cells. As stated on their website, Regenexx is "a non-surgical treatment option for people suffering from moderate to severe joint or bone pain due to injury or other conditions."

Regenerative Sciences found itself at the center of an important controversy when, in July of 2008, Dr. Centeno received a letter from the U.S. FDA (Food and Drug Administration) stating that the autologous adult mesenchymal stem cells processed with Regenexx are considered to be "drugs" since they are intended for therapeutic use. According to the FDA letter, "These cells are considered drugs because the therapeutic claims shown on your website demonstrate that they are intended for use in the diagnosis, cure mitigation, treatment or prevention of disease in man." The letter concluded by stating, "Please be advised that in order to introduce or deliver for introduction a drug that is also a biological product into interstate commerce, a valid biologics license must be in effect. Such licenses are issued only after a showing of safety and efficacy for the product's intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations... The mesenchymal stem cells utilized in your Regenexx procedure are not the subject of an approved biologics license application (BLA) nor is there an investigational new drug application (IND) in effect. Therefore, your implantation of the mesenchymal stem cells for which a valid license or IND is not in effect appears to violate the Act and the PHS Act and may result in the FDA seeking relief as provided by law."

Regenerative Sciences responded by posting the following notice on their website, which was most recently updated on March 31, 2009: "Last summer we got a letter from the FDA stating that they felt that our Regenexx medical procedure was actually the manufacturing of a new drug. The letter made no sense, as what we're doing is practicing medicine. We kindly wrote back stating our position and then we didn't hear back for more than half a year. Recently, the FDA has again asserted that they believe we are manufacturing a drug. They haven't given any credible rationale for why they believe this, as what we're doing with adult stem cells is no different than the average fertility clinic that grows embryos in culture for re-implantation. The fertility clinic is not regulated as a drug manufacture facility. The fertility specialists fought that fight and won."

This is a critically important issue, since it illustrates the frustration that many, if not all, adult stem cell scientists in the U.S. feel, as it this stance by the FDA which poses an insurmountable, not to mention entirely illogical, hindrance to adult stem cell therapies in the United States. For anyone who has ever wondered why it is that adult stem cell therapies are available in ordinary clinics in most countries outside of the U.S., but only in a limited number of FDA-approved clinical trials within the U.S., here's your answer: the FDA considers each person's own autolgous adult stem cells to be a "drug", and therefore those stem cells are subject to the same multi-year, multi-million-dollar clinical trial process through which all pharmaceutically produced drugs must pass before being considered legally marketable within the United States.

The statement on the website of Regenerative Sciences continues: "ASCTA (American Stem Cell Therapy Association) is a physician organization that was formed in opposition to the FDA's position that adult stem cells are drugs. This group heralds a much bigger movement than what we're doing here with the Regenexx procedure. We've found literally an outcry by patients with chronic diseases that the FDA would stand in their way of getting safe stem cell work performed by their doctors. We agree that there are hundreds of likely unsafe stem cell outfits around the globe injecting God-knows-what into whoever has the will to pay. All the more reason for an organization to step to the forefront to establish physician-run guidelines for safe lab practices and clinical oversight... The pre-clinical research on adult stem cells is much stronger than embryonic stem cells... When I've posed the question to numerous doctors and experts in the field, are your own stem cells drugs? They look at me like I'm crazy, and often reply 'Of course my stem cells aren't drugs!' Why would the FDA take the position that your cells are drugs... The ASCTA physician group will be getting out its lab practices guidelines meant to hold new adult stem cell practices to the highest standards to protect patients. Our goal is clear and it's worth fighting for: Safe Stem Cells Now!"

Likewise, the ASCTA has posted the following statement on their website: "The American Stem Cell Therapy Association (ASCTA) announced today the online publication of its mission statements and charter. The organization was formed in response to the Food and Drug Administration's (FDA) recent position that the adult stem cells found in everyone's body are drugs, a position the ASCTA opposes. This physician organization is establishing laboratory guidelines that will allow doctors to bring adult stem cell therapy to their patients more quickly. These guidelines will be similar to those used by fertility specialists in in-vitro fertilization (IVF) labs, where many of the same cell culture techniques are used."

Dr. Centeno, one of the founding members of the ASCTA, is quoted on the ASCTA's website where he states, "Many patients are dying or suffering daily with incurable diseases or problems that require major surgery. These patients should have access to basic adult stem cell therapy now. ASCTA is establishing guidelines which will allow the safe use of the patient's own adult stem cells under the supervision of doctors." According to Dr. Frank Falco, another ASCTA founding member who is also quoted on the ASCTA's website, "The FDA's position against someone using their own stem cells is taking it too far. We are talking about a person using their own tissue to treat a degenerative disorder or process safely without the use of medications or surgery. Although we agree that oversight and standards are necessary, this should be provided through a physician organization such as ASCTA rather than by a government agency."

Not all stem cells are created equal, of course, and it is vitally important that the FDA make distinctions between embryonic, fetal and adult stem cells. In this regard, the ASCTA website continues, "Adult stem cells are different than embryonic stem cells. Adult stem cells are found in the patient's body in various tissues. In order to obtain enough stem cells for treatment, they often need to be cultured, similar to today's fertility treatments. Adult stem cells have undergone much more research than embryonic stem cells and therefore are closer to real world treatments. These adult stem cells are taken from the patient's own body (autologous) and ASCTA believes that they are therefore the safest for use in treating patients." To this Dr. Centeno adds, "While the Obama administration seems to have opened the embryonic stem cell door, their FDA seems to want to slam the adult stem cell door shut."

As also stated on their website, "The ASCTA is a physician group comprised of various medical and surgical specialists whose goal is to bring safe stem cell therapy to patients by establishing laboratory and clinical guidelines." More information is available at www.stemcelldocs.org.

Additionally, in April of 2009 a patient movement called "Safe Stem Cells Now!" was formed in response to the FDA's unfounded position that a person's own adult stem cells are "drugs" and therefore should be regulated in the same manner. More information is available at www.safestemcells.org.

As Barbara Hanson, cofounder of www.stemcellpioneers.com, states, "Adult stem cells are cells from our own body. They are very safe. There are no moral or ethical issues. They are safer than taking aspirin and yet the FDA has classified our own stem cells as drugs that require regulation. This means that prolonged investigations, including lengthy clinical trials, will be required for each and every disease and application that adult stem cells could be used for. This could take years and years. It smells of big pharma to me and many others."

Indeed, many people feel that this stance by the FDA is purely politically and economically motivated. At the very least, it is an entirely unscientific stance, and it is merely one example of the numerous ways in which the FDA needs to update its regulations so that these regulations are relevant and applicable to stem cells, which do not fall into any of the previously existing categories for which the FDA has ever had to formulate national law in the past. Such outdated laws are precisely what is driving many of the best and most accomplished adult stem cell physicians and scientists "off-shore", to set up their laboratories and clinics anywhere at all in the world, just as long as it is outside the borders of the United States. In the end, it is the U.S. patient who suffers, since the researchers and clinicians themselves are not stopped but are merely forced to relocate to other countries. Until the FDA is able to recognize the numerous and vast differences between an autologous adult stem cell and a pharmaceutically manufactured drug, it is no wonder that adult stem cell companies such as NeoStem and Regenerative Sciences are able to form licensing agreements throughout all of Asia, but not in their own home country, the United States.