Stem Cell Clinical Trials for Stroke & Cerebral Palsy

via Science Daily

Two new federally funded studies are investigating the optimal dosage and timing for stem cell therapy in adults with strokes and newborns with ischemic injuries, which can result in cerebral palsy. The studies are currently using bone marrow stem cells in animal models, but lead researchers indicate that success during preliminary studies could lead to human clinical trials within two years.

If these additional laboratory studies replicate the promising results of the pilot studies, which indicate about a 25 percent improvement in recovery over controls, MCG and VA researchers hope to begin clinical trials in new ischemic injuries in adults and children within two years.

“We are looking at different procedures that we can adopt from the laboratory for the clinic,” Dr. Borlongan says. “We have at least 10 years of basic research that clearly shows that stem cells have the potential to be a new therapy for adult stroke.”

“This is a whole new paradigm, a totally different way of targeting disease,” says Dr. David Hess, chair of the MCG Department of Neurology and co-investigator. Clot buster tPA is the only drug that is FDA-approved to treat ischemic strokes; an often-delayed diagnosis and a three-hour treatment window mean only a small percentage of patients get it.

Drs. Hess and Borlongan say cell therapy could eventually be used alone or in conjunction with tPA, if recovery is not sufficient. Pilot studies indicate cell therapy can be of benefit up to seven days after a stroke but that two days out is the optimal time of delivery. “This will allow us to enroll patients who get tPA, give us plenty of time to assess them and prepare the cells,” says Dr. Borlongan.

Their success in an adult stroke model led the researchers to explore the potential for helping babies recover from hypoxic ischemia, a loss of blood and oxygen that can result in cerebral palsy, broadly defined as a brain injury that occurs before or during birth.