The Shady Side of
Embryonic Stem Cell Therapy

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 likely and should be regarded with extreme skepticism. The main commercial sources appear to be the 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

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.

Stem Cell of America (formerly called Medra, Inc.)

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:

The fetal stem cell searches out, detects and then attempts to repair any damage or deficit discovered, as well as releases growth factors, which stimulate the body's own repair mechanisms. . . .

A partial list of diseases includes:

Alzheimer’s, Anemia, Autism, Brain damage, Cancer, Cerebral Palsy, Chronic Fatigue Syndrome, Depression, Diabetes, Diverticulitis, Epilepsy, Impotence, Immune Suppression, Leukemia, Multiple Sclerosis, Parkinson’s, Rheumatoid Arthritis, Sickle Cell Anemia, Spinal Cord Injury, Stroke, Systemic Lupus Erythematosus and Ulcerative Colitis. . . .

Rarely has a single treatment modality offered so much promise to those suffering from some of mankind's worst afflictions [16].

Rader has also claimed that by "strengthening the immune system, fetal cells offer prevention from acquiring multiple diseases, including cancer, where the fetal cells actually form an anti-cancer barrier which becomes another anti-aging factor." [13] I don't believe that. In order to substantiate such claims, thousands of people would have to be followed in a controlled trial that lasted many years. Stem cell technology has not existed long enough for any such study to have been done.

Medra, Inc.'s "Factsheet" identified Rader as medical director and "Prof. Albert Scheller, M.D., Ph.D." as "chief scientific investigator." Searching Medline, I found no publications one by either of them that are relevant to the claims they made for Medra's treatment. In 2011, Medra changed its name to Stem Cell of America and Rader's clinic was moved from the Dominican Republic to Mexico.

Beijing Xishan Institute for Neuroregeneration and Functional Recovery

The Beijing Xishan Institute for Neuroregeneration and Functional Recovery in Beijing, China, is offering stem cell treatment for spinal cord injury, amyotrophic lateral sclerosis Alzheimer’s disease, cerebral palsy, stroke, Parkinson’s disease and other neurodegenerative conditions. Its founder/director, Dr. Hongyun Huang, is a neurosurgeon who did research on the biology of fetal cells at Rutgers University and New York University before returning to China. Huang says he injects patients with olfactory sheathing cells (OSCs) obtained from aborted fetuses. The Institute is reported to have treated hundreds of patients and to have thousands of people on its waiting list. The cost is reported to be over $20,000 [17]. In 2003 Huang reported his experience with 171 patients and claimed that OEC transplantation can improve the neurological function of spinal cord of spinal cord injury patients regardless of their age [18]. However, his report contains no raw data, provides few details of the patients' functional ability, did not compare the patients to untreated patients, and limited the patient evaluations to only 2 to 8 weeks after the operation. In 2006, the journal Neurorehabilitation and Neural Repair published a detailed report on his results with seven patients whom the authors examined before and one or more times within a year after Huang's treatment. The authors concluded: (a) five of the seven patients had significant complications (three had meningitis), (b) none of the patients showed objective evidence of improvement, and (c) unless Huang conducts a proper study, patients would be ill-advised to undergo his treatment [19]. A report in the Boston Globe noted that Huang's website includes profiles of patients he has treated for a wide variety of conditions with different causes and different symptoms, yet Huang treats them all with the same cells [17].

Other Clinics

At least two other clinics have advertised stem cell treatment. The Brain Therapeutics Medical Clinic is run by David Steenblock, D.O., who claims to have "put together a number of growth factors and natural products that are known to promote and protect new brain cells" and calls stem cell therapy a "new and exciting treatment for brain regeneration." The clinic's Web site states that Steenblock "has devoted many years to research in the fields of biochemistry, pathology, nerve and muscle physiology, cardiovascular disease and other diseases of aging." Yet a Medline search shows that his only mainstream journal publications were three co-authored articles about clotting factors in dogs and guinea pigs—all published in the late 1960s when he worked as a laboratory research assistant during his osteopathic training. In 1994, after being charged with negligently treating two patients, Steenblock signed a stipulation under which he admitted failing to adequately document their management and had failed to issue a warning about possible side effects of an injection he had administered to one of them. He was assessed $10,000 and placed oin five years' probation under which he was required to take extra continuing education courses in pharmacology, medical charting, and ethics [20]. In 1995, after the door to his hyperbaric oxygen chamber blew out (injuring three persons), investigators noted that he was using three unlicensed persons as "physical therapy assistants." [Subsequent charges that he had violated his probation resulted in extending his probation for another three months and assessment of another $3,500 in costs [21].

The Vita Nova Clinic offers stem cell therapy designed and administered by Professor Yuliy V. Baltaytis, MD, PhD, DSc. The Vita Nova site claims that Baltaytis has written six books and over 200 scientific articles and has successfully treated patients with arthritis, Alzheimer's, cancer, diabetes, leukemia, and many other conditions. However, he has no publications indexed in Medline and is not mentioned on any other Web site (which I would expect if he had significant scientific standing). I see no more reason to trust him or Steenblock than there is to trust the others mentioned above.

In 2009, a team of Israeli scientists reported that a teenage boy had developed tumors of his brain and spine four years after beginning stem cell treatment at a Russian clinic. The tumors appear to have been derived from the transplanted stem cells. The boy has a rare neurological disease that local doctors say could not have been helped by stem-cell therapy [22].

Cord Blood Banking

The Cord Blood Registry (Cbr) rel="nofollow", headquartered in San Bruno, California. provides processing and storage of stem cells from umbilical cord blood for potential future use by the child or family members. In 2010, its fees were $2,195 initially and $125 per year for storage after the first year. Cryobanks International, located in Alamonte Springs, Florida, offers what appears to be similar services. Its 2010 fees were $1,399 for the first year and $120 per year after that, with discounts available for long-term prepayment.

Cbr's Web site states that stem cells are being used to treat a variety of cancers and blood disorders and that research shows possible value against Alzheimer's disease, Parkinson's disease, and heart disease. It also states that, "Saving your baby's cord blood . . . can be lifesaving to your family." [23] However, The American Academy of Pediatrics (AAP) states there is no strong evidence to recommend routine cord blood banking for an infant's future use. It's 2007 position statement on that subject states:

Others have noted that people who receive their own stem cells might be prone to repeat the same disease. In March 2004, The Medical Letter concluded: "At the present time, private storage of umbilical cord blood is unlikely to be worthwhile. Parents should be encouraged to contribute, when they can, to public cord banks instead." [25]

The Bottom Line

Although stem cell therapy has a few practical applications and considerable promise, there is no reason to believe that EmCell, Medra, the Brain Therapeutics Medical Clinic, Vita Nova, the Beijing Xishan Institute for Neuroregeneration and Functional Recovery, or any other commercial stem-cell clinic are providing it as a legitimate service. Their theories and methods are simplistic; their treatments may have adverse effects; they offer no credible outcome data; and their promises go far beyond what is now possible.

Cord blood banking has some legitimate uses but appears to be a poor investment except for people who (a) have a relative with a disease for which cord blood effectiveness has been demonstrated or (b) are wealthy enough to afford betting more than $3,000 on a long shot.

References

  1. Stem cell basics. NIH Web site, accessed September 24. 2009.
  2. What would you hope to achieve from human pluripotent stem cell research? National Institute of Health Web site, April 26, 2000.
  3. Embryonic stem cell transplantation: 13 years of clinical experience. EmCell Web site, accessed June 19, 2006.
  4. Historical background of embryonic stem cell transplantation. EmCell Web site, accessed June 19, 2006.
  5. Features of embryonic stem cell transplantation. EmCell Web site, accessed accessed June 19, 2006.
  6. Major curative effects of embryonic stem cell transplantation. EmCell Web site, accessed accessed June 19, 2006.
  7. Main effects and specific features of embryonic stem cell transplantation. EmCell Web site, accessed accessed June 19, 2006.
  8. The list of conditions and diseases, where we applied embryonic stem cell transplantation with positive results. EmCell Web site, accessed accessed June 19, 2006.
  9. Experience in treatment of oncology patients. EmCell Web site, accessed accessed June 19, 2006.
  10. Cord blood review. ALS Web site, Dec 2002.
  11. What's happening with cord blood. ALS-TDF Web site, Dec 2002.
  12. Wahlberg D. FDA studies ALS doctor, treatment. Atlanta Journal-Constitution, March 29, 2003.
  13. Hundley K. Mining medical waste. St. Petersburg Times May 12, 2003.
  14. Review of EmCell by ALS-TDF. ALS-TDF Web site, June 2002.
  15. Rader W. Documents faxed in 1997.
  16. Fetal stem cell therapy factsheet. May 2004.
  17. Cook G. Chinese surgeon's claims about cell implants disputed. Boston Globe, June 19, 2006.
  18. Huang H and others. Influence of patients' age on functional recovery after transplantation of olfactory ensheathing cells into injured spinal cord injury. Chinese Medical Journal 116:1488-1491, 2003.
  19. Dobkin BH and others. Cellular transplants in China: observational study from the largest human experiment in chronic spinal cord injury. Neurorehabilitation and Neural Repair 20:5-13, 2006.
  20. Barrett S. Regulatory action against David Steenblock, D.O. (1993-1994) Quackwatch, March 31, 2004.
  21. Barrett S. Regulatory action against David Steenblock, D.O. (1997-2000). Quackwatch. March 31, 2004.
  22. Amariglio N and others. Donor-derived brain tumor following neural stem cell transplantation in an ataxia telangiectasia patient. PLoS Med 6(2): e1000029. doi:10.1371/journal. pmed.1000029.
  23. CBR home page, accessed Sept 9, 2010.
  24. Policy Statement: Cord blood banking for potential future transplantation. Pediatrics 119:165-170, 2007.
  25. Private cord blood banks. The Medical Letter 46:21-22, 2004.

This article was revised on September 14, 2012.

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