Novel stroke treatment passes safety stage of UC Irvine-led clinical trial
Sequential-growth-factor therapy holds promise for improving recovery outcomes
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 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 UC Irvine, 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.
About the University of California, Irvine: Founded in 1965, UC Irvine is a top-ranked university dedicated to research, scholarship and community service. Led by Chancellor Michael Drake since 2005, UC Irvine is among the most dynamic campuses in the University of California system, with nearly 28,000 undergraduate and graduate students, 1,100 faculty and 9,000 staff. Orange County’s second-largest employer, UC Irvine contributes an annual economic impact of $4 billion. For more UC Irvine news, visit today.uci.edu.
News Radio: UC Irvine maintains on campus an ISDN line for conducting interviews with its faculty and experts. Use of this line is available for a fee to radio news programs/stations that wish to interview UC Irvine faculty and experts. Use of the ISDN line is subject to availability and approval by the university.