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Stem Cell Treatments in China

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Medical Update Memo
May 15, 2008

SUMMARY

The April 3 issue of Neurology Today reports on stem cell transplant work being done in China.

Little has been known about the methodology used by Chinese physicians in treating people with spinal cord injury (SCI), amyotrophic lateral sclerosis (ALS), and multiple sclerosis (MS) because to date, no phase 3 trials have been initiated to test these therapy protocols being used in China.

DETAILS

People are paying up to $60,000 USD for cell transplants administered by epidural or intravenous injections or sometimes transplants to the frontal lobe of the brain. Stem cells for transplant are derived from aborted fetuses, cultured olfactory ensheathing cells (OES’s), cultured cord-blood derived stem cells, as well as autologous bone marrow transplantation (BMT). In autologous BMT, stem cells are harvested from the individual’s own bone marrow and are then re-infused back into the patient.

Neurology Today summarizes the limited peer reviewed publications to date. One case report published in the journal Spinal Cord cites an individual with spinal cord injury who improved briefly but also developed meningitis as a complication of therapy.

In a 2006 paper published in Neurorehabilitation and Neural Repair, 7 SCI patients were followed and authors reported that no clinically useful sensory or motor improvements could be substantiated, nor did they see any improvements in disability or autonomic function. In addition, they found complications including meningitis. Reports on the Chinese experience in multiple sclerosis are also incomplete with limited or no information on protocol, study population characteristics, investigator bias, and statistically significant outcomes.

Dr. Paul O’Connor – national scientific and clinical advisor to the MS Society of Canada:

"Stem-cell therapy is of great interest but unproven benefit in the treatment of MS. There are many different ways to give this type of therapy (in the vein vs directly into the nervous system; with or without chemotherapy), each of which can have very different results from the next.

"For any proposed stem-cell treatment, what we need are properly designed clinical trials that can test its safety and effectiveness. To date, no form of stem-cell therapy in MS has been rigorously tested to the standards that we use in testing the effectiveness of new drugs and the use of stem-cell treatments is not recommended as part of routine care in MS."

Dr. Mark Freedman – neurologist and principal investigator, Canadian Bone Marrow Transplant Project, Ottawa Hospital:

"The promise is out there for the use of stem cells to treat many of these disorders, but if people continue to flock to countries allowing this type of unproven therapeutic measure to be used and subject themselves to treatments that may cause more harm than good, then this may threaten the viability of this whole area of research.

"Safety measures must be worked out along with establishing clear proof of benefit. Neither of these can be claimed by centres performing this work."

ASK MS Information System Code: 1.4.2.12.v

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