Irvine, Calif., March 10, 2010 – A clinical research trial of a new treatment to
restore brain cells damaged by stroke has passed an important safety stage,
according to the UC Irvine neurologist who led the effort.
Dr. Steven C. Cramer said patients showed no ill effects after the sequential
administration of growth factors encouraging the creation of neurons in
stroke-damaged areas of the brain. All new drug treatments must pass this safety
stage before doctors can study their effectiveness in subsequent studies.
Results of the phase IIa trial appear on the Web site of Stroke, a journal of
the American Heart Association.
Within two days of suffering ischemic stroke, patients were put on a nine-day
treatment course, starting with three once-daily injections of beta-hCG, a
hormone that triggers the growth of neural stem cells. They then received three
once-daily injections of erythropoietin, a hormone that directs these neural
stem cells to become neurons.
Cramer, associate professor of neurology at UCI, said this combination of growth
factors had been shown in animal studies to engender neuron creation leading to
the recovery of a range of movement.
In the human safety study, he teamed with physicians from UC Irvine Medical
Center; Hoag Memorial Hospital Presbyterian in Newport Beach, Calif.; and the
University of Calgary in Canada. They administered the treatment to 15 patients.
No safety concerns were noted, and a majority of treated patients had minimal or
no disability after three months.
A phase IIb clinical trial is now under way to compare the stroke therapy with
placebo.
The study is supported by Stem Cell Therapeutics a Canadian biotechnology
company that conceived of an approach using this specific sequence of growth
factors and the National Center for Research Resources.
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