LOOK AT RADER'S MEDRA INC.:

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; Medra, Inc, in the Dominican Republic; 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:
Scientists at the center have been doing embryonic stem cell transplantation
for 13 years, have performed 2,000 transplants, and have "the worlds largest
clinical experience . . . in various diseases and conditions." [3]
Smikodub was the "first in the world to introduce schemes of treatment of
many diseases of internal illnesses . . . involving embryonic cell
suspensions of mesenchymal, ectodermal, and endodermal origin." [3]
The cells used at the the clinic "do not possess antigenic properties,
making rejection impossible." [5]
No negative side effects were observed [4].
"Curative effects of Embryonic Stem Cell Transplantation in numerous
diseases are far beyond the possibilities of any other modern method." [6]
Shortly after transplantation, patients experience "increased vigor,
improved feeling of inner strength, belief in favorable result in treatment,
absence of depression, improvement of mood and mental creativity." [7]
"Restored functional activity of impaired and damaged internal organs and
tissues leads to steady recovery." [7]
The treatment has achieved "positive results" in cancer, AIDS, diabetes,
multiple sclerosis, Crohn's disease, and more than 50 other diseases and
conditions [8].
Cell therapy contributes to "antitumoral immunity" and can be used to
prevent disease as well as relapses and metastases [9].
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:
EmCell did not answer many of the questions, and in some areas refused to
elaborate on important details such as their method for screening against
the AIDS or hepatitis viruses in the cells or their method of cell
extraction.
We also asked . . . questions that focused on how they were able to report
on patients who have benefited from the treatment. They were not willing to
explain their conclusions or how they reached them.
We have not found any data that suggests that the methodology used by EmCell
is scientifically reasonable, or that it is helping ALS patients. Although
the Foundation has not received any reports of ALS patients being harmed by
EmCell, the Foundation has not received any verifiable reports of
improvement following EmCell treatment either.
Stem cell therapy is being pursued by a number of credible institutions
around the world and ALS-TDF is working with many of the leaders in that
area. EmCell's $15,000 stem cell therapy bears very little resemblance to
what is currently being done in leading institutions around the world.
One of the main elements that makes EmCell's approach different from these
leading institutions is their method of delivery. EmCell is injecting fetal
stem cells into the abdomen and veins of patients. This approach is similar
to the therapy that has been offered in Mexico, in which they have been
using bovine stem cells as a cell source. However, those who visited these
Mexican clinics have not shown any measurable benefit that we know of to
date.
EmCell suggested to us that the number of cells does not matter since the
cells will divide once they are in the body. If EmCell believes this is
true, this raises a significant red flag since the effect of every credible
stem cell therapy tried to date has been, in part, dependent on the number
of cells injected. Dose does matter, and it indicates there is a lack of
understanding on the part of EmCell about how stem cells work.
EmCell suggests that these stem cells DO NOT draw the attention of the
immune system. This is another red flag. It is well known that the immune
system will generally eliminate any foreign cell, especially in the
peripheral system where EmCell is transplanting the cells. Newly injected
cells are very unlikely to live very long without some form of immune
suppression. In current US stem cell experiments, immunosuppressive drugs
are generally used.
Most scientists . . . do not believe it's plausible to inject a limited
number of cells into the abdomen and have them travel into the brain in any
way that would help in ALS.
EmCell does not appear to have any real tracking mechanism in place to
identify improvements and declines in their patients after they have
returned home. After talking with several patients who visited the clinic,
it is clear that no evaluation was made of their physical or neurological
condition. It is suspicious that they are making claims of improvement for
an entire group of people that were not followed in a manner that could
generate any viable claims [14].
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.
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 Dominican
Republic clinic. In the past, he has also done business under the names
Mediquest Ltd., Czech Foundation, and Dulcinea Institute, Ltd. 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 claims that his treatment enables chemotherapy
and radiation to continue longer and virtually eliminate their side effects
[15]. Medra's "Factsheet" claims:
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 also claims 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] 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" identifies 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 make for Medra's treatment.
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
Cell Therapeutic Clinic, 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.
Cord Blood Banking
The Cord Blood Registry (Cbr), 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. Its fee is $1,850 plus
$125 per year for storage. Cryobanks International, located in Alamonte
Springs, Florida, offers what appears to be similar services. Its current
fees are $1,299 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 may one day help your baby, siblings,
or other family members should they ever need it." [22] 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 1998
position statement on that subject states:
No accurate estimates exist of the likelihood of children to need their own
stored cells. The range of available estimates is from 1 in 1,000 to 1 in
200,000. For this and other reasons, it is difficult to recommend that
parents store their children's cord blood for future use.
Given the difficulty in estimating the need for using one's own cord blood
cells for transplantation, private storage of cord blood as "biological
insurance" is unwise. However, banking should be considered if there is a
family member with a current or potential need to undergo a stem cell
transplantation. For example, conditions such as leukemia or severe
hemoglobinopathy may indicate the need for directed-donor cord blood banking
for sibling cord blood transplantation.
If cord clamping is done too soon after birth, the infant may be deprived of
a placental blood transfusion, resulting in lower blood volume and increased
risk for anemia later in life [23].
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." [24]
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 Cell
Therapeutic Clinic, Vita Nova, or the Beijing Xishan Institute for
Neuroregeneration and Functional Recovery 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
Stem cell basics. NIH Web site, accessed August 2, 2003.
What would you hope to achieve from human pluripotent stem cell research?
National Institute of Health Web site, April 26, 2000.
Embryonic stem cell transplantation: 13 years of clinical experience. EmCell
Web site, accessed June 19, 2006.
Historical background of embryonic stem cell transplantation. EmCell Web
site, accessed June 19, 2006.
Features of embryonic stem cell transplantation. EmCell Web site, accessed
accessed June 19, 2006.
Major curative effects of embryonic stem cell transplantation. EmCell Web
site, accessed accessed June 19, 2006.
Main effects and specific features of embryonic stem cell transplantation.
EmCell Web site, accessed accessed June 19, 2006.
The list of conditions and diseases, where we applied embryonic stem cell
transplantation with positive results. EmCell Web site, accessed accessed
June 19, 2006.
Experience in treatment of oncology patients. EmCell Web site, accessed
accessed June 19, 2006.
Cord blood review. ALS Web site, Dec 2002.
What's happening with cord blood. ALS-TDF Web site, Dec 2002.
Wahlberg D. FDA studies ALS doctor, treatment. Atlanta Journal-Constitution,
March 29, 2003.
Hundley K. Mining medical waste. St. Petersburg Times May 12, 2003.
Review of EmCell by ALS-TDF. ALS-TDF Web site, June 2002.
Rader W. Documents faxed in 1997.
Fetal stem cell therapy factsheet. May 2004.
Cook G. Chinese surgeon's claims about cell implants disputed. Boston Globe,
June 19, 2006.
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.
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.
Barrett S. Regulatory action against David Steenblock, D.O. (1993-1994)
Quackwatch, March 31, 2004.
Barrett S. Regulatory action against David Steenblock, D.O. (1997-2000).
Quackwatch. March 31, 2004.
Cord blood banking for potential future transplantation: Subject review.
Pediatrics 104:116-118, 1999.
Banking your newborn's blood. KidsHealth Web site, June 2004.
Private cord blood banks. The Medical Letter 46:21-22, 2004.
This article was revised on June 19, 2006.
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