This week, announcements of deals to bank and use umbilical cord blood in China, India, Vietnam and South Korea point to an industry that is both promising and prone to overpromising. Companies trying to attract self-paying patients often conflate established therapies with highly experimental and unproven procedures.
Cord blood banking is already an established business. Today, BioSpectrumAsia reported a joint venture between Apollo Therapeutics and Cadila Pharmaceuticals in India and the well-known cord blood company StemCyte.
Established uses cord blood include blood disorders, bone-marrow failure, and genetic metabolism disorders. Many researchers are trying to figure out just what these cells are capable of. Saudi Arabia is heavily investing in blood-derived stem cells and banks geared at treating the population in the Middle East. ( See our article ). The Chinese government has also announced plans to open two more umbilical cord blood banks for non-kin transplants.
In a policy statement that’s full of information, the American Academy of Pediatrics discourages private cord blood banking and warns against unsubstantiated claims. “Cord blood donation should be discouraged when cord blood stored in a bank is to be directed for later personal or family use, because most conditions that might be helped by cord blood stem cells already exist in the infant’s cord blood (ie, premalignant changes in stem cells).”
This is the kind of private cord blood service that will soon be offered in Vietnam. Vietnamnet reports that a Singapore company, CordLabs, agreed to transfer technology to a Vietnamese company, Mekophar. Beginning some time next quarter, parents can, for $2000, deposit umbilical cords and umbilical membranes of their children for 25 years. According to an earlier article, the company intends to establish four stem cell banks in Vietnam. The articles indicate that the project also includes public banking and charity services, plus Vietnam’s desire to foster this kind of research. The articles did not specify what promises were being made to parents.
A merger of an umbilical cord stem-cell company with a stem-cell company reveals the broadest and most unsubstantiated claims. South Korea-based Histostem plans to merge with the Florida company, Stem Cell Therapy International.
Though StemCyte can be accused of overstating, the only disease that StemCyte mentions specifically on its homepage is the blood disorder thalassemia. Stem Cell Therapy’s website, in contrast, is full of promises. It boasts videos and personal accounts of patients receiving stem cell therapies for multiple sclerosis and stroke. Two “solutions” are the “rejuvenation of women during menopause” and “complex therapy of cosmetics problems.” Its website states, “A documented 5 millions of patients have been so treated worldwide to-date, evidenced by over 120,000 publications in MEDLINE amongst others.” It does not say that the vast majority of current stem-cell treatments are for blood disorders or to supply functioning bone marrow. Nor does it say that stem-cell treatments for neurodegenerative disorders are, to say the least, far from established. A review on blood- and marrow-derived stem cell treatments in JAMA published Feb 27, 2008 by Burt and others found only 69 reports to assess, including several on multiple sclerosis. The editors’ summary was “Their analysis suggests that stem cells harvested from blood or bone marrow may provide modest disease-ameliorating effects in selected patients with some autoimmune diseases and some cardiovascular disorders.”
At the bottom of Stem Cell Therapy’s home page, are glowing adjectives: “approved” among them, but clicking on that word does not tell me what entity approved the therapies. Here’s how the head of the Korean Histostem, Han Hoon, describes the strategy in a press release issued by the two companies. “We intend to take the research data that the Korean FDA already approved and submit it to the U.S. FDA, with the objective of getting the U.S. FDA approval in advance of other companies now researching umbilical stem cell treatments for a variety of different diseases." My understanding is that while the Korean FDA is supervising some trials with these cells, it has not approved any therapies.
There are organizations that are trying to ensure that promising results for potential therapeutic applications don’t transform into unsubstantiated claims. The Stem Cell Network of the Asian-Pacific Region ( SNAP ) has taken on the ambitious goal of helping people know where the science stands because, in the words of one of the founders, “There’s a lot of bad information out there.”