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The Shady Side of Embryonic Stem Cell Therapy

June 1st, 2015 4:47 pm

Stephen Barrett, M.D.

Stem cell therapy is certainly a promising area for research. Stem cells have the ability to give rise to many specialized cells in an organism. Certain types of stem cells are already used to restore blood-forming and immune system function after high-dose chemotherapy for some types of cancer, and several other restorative uses have been demonstrated. The broadest potential application is the generation of cells and tissues that could be used to repair or replace damaged organs. If scientists can learn how to control stem cell conversion into new, functionally mature cells, doctors might be able to cure many diseases for which therapy is currently inadequate [1,2]. However, the claims made by commercial promoters go way beyond what is now likely and should be regarded with extreme skepticism. The main commercial sources have included Embryonic Tissues Center in the Ukraine; Stem Cell of America (formerly called Medra, Inc) in Mexico; the Brain Therapeutics Medical Clinic (formerly called the Health Restoration Medical Center and the Brain Cell Therapeutic Clinic) in Mission Viejo, California; the Vita Nova Clinic in Barbados; and the Beijing Xishan Institute for Neuroregeneration and Functional Recovery in Beijing, China.

The Embryonic Tissues Center (EmCell) appears to be the oldest commercial source of embryonic stem cell therapy. Its proprietors, Alexander Smikodub, M.D., Ph.D., and Alexey Karpenko, M.D., Ph.D., are described as professors at National Medical University. The EmCell Web site claims:

How credible are these claims? How are the cells prepared? Are steps taken to ensure that they are not infectious? How was it determined that patients have no side effects? Does the clinic follow its patients and keep score? Have enough cancer patients to determine 5-year survival rates? Have Smikodub and Karpenko published their results? Do their theories and methodology make sense?

The ALS Therapy Development Foundation has been monitoring claims that fetal stem cell infusions might be effective against amyotropic lateral sclerosis (Lou Gehrig's disease). Its Web site states that two American physicians (Mitchell Ghen, D.O., and Dan Cosgrove, M.D.) have treated patients in a "new and untested way," but so far no conclusions could be drawn about effectiveness. Foundation documents also note that (a) some patients have experienced flu-like symptoms, (b) three patients have had dark-colored urine that may signify hemolytic anemia and/or kidney damage, and (c) it is not clear whether the stem cells are actually surviving long enough to have an effect [10,11]. In March 2003, the FDA seized records at Ghen's clinic and Cosgrove said he had stopped offering the treatment [12]. Cryobanks International, which had supplied the cells to Ghen and Cosgrove, stopped doing so after the FDA contacted them [13].

The ALS Foundation has also investigated the Cell Therapy Clinic by talking with a staff physician, sending a detailed follow-up questionnaire, and talking with several former patients. The Foundation's report states:

In August 2003, I did Medline searches to see whether Smikodub or Karpenko had published any reports about their patients in peer-reviewed medical journals. I found none that appeared relevant to the curative claims described above.

The chief American commercializer of embryonic stem cell therapy is William C. Rader, M.D., a psychiatrist in Malibu, California, who used to run Rader Institute clinics that specialized in treating eating disorders. For $25,000 (wired in advance), Rader will arrange for treatment at his Mexican clinic. In the past, he has also done business under the names Mediquest Ltd., Czech Foundation, Dulcinea Institute, Ltd., and Medra, Inc. A message posted to the Yahoo StemCells group indicates that before he opened his own clinic (in 1997 in the Bahamas), Rader escorted patients to the Ukraine clinic. Like EmCell, Rader has claimed that his fetal stem cell treatment is not antigenic and has no side effects. In a 1997 document, he stated:

Because fetal cells uniquely do not have antigenicity, they can be given to anyone with no reaction, no rejection, immunusuppressive drug therapy, or any side effects whatsoever. When a patient receives fetal fresh cell therapy (usually given intravenously over a few hours. . . ), the first action of cells is to stimulate the cells already present in the recipient's system, making them more potent. Then they actually replace the recipient's immune cells and, eventually engraft, which means they actually continually grow more fetal cells, resulting in a new and stronger immune system [15].

With respect to cancer, Rader has claimed that his treatment enables chemotherapy and radiation to continue longer and virtually eliminate their side effects [15]. Medra's "Factsheet" claimed:

Read more here:
The Shady Side of Embryonic Stem Cell Therapy

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