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12:00 AM
Mar 12, 2001
 |  BioCentury  |  Tools & Techniques

Protocol counts in Parkinson's

The negative outcome of a trial of fetal stem cells in patients with Parkinson's disease is likely to provide fodder to opponents of fetal stem cell therapy. But the methods used in the trial differed substantially from those used by other groups doing fetal neuron transplants, indicating that changes in protocols can substantially affect patient outcomes.

A placebo-controlled trial reported last week in The New England Journal of Medicine demonstrated a lack of efficacy compared to previous, open-label studies of the procedure. Particularly disturbing was that 15 percent of the young patients who had showed improvement developed severe dyskinesias (involuntary abnormal movements) after the first year of observation.

In the 40-patient trial run by researchers at the University of Colorado in Boulder, patients received transplantation of dopaminergic neurons derived from aborted fetuses into a region of the brain called the putamen. The approach showed a trend towards efficacy with a decrease (improvement) in the Unified Parkinson's Disease Rating Scale of 15 percent after one year.

In a subset of patients 60 years of age or younger, scores dropped 28 percent at the end of one...

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