Asterias Biotherapeutics, a California-based company that’s testing a stem cell based-therapy, has announced some early and promising results of its clinical trial for spinal cord injury patients.
A total of six patients were enrolled and treated with 10 million AST-OPC1 cells, with five of six patients having now completed a 6-month follow-up, and three of six patients having completed a 9-month follow-up.
“With these patients, we are seeing what we believe are meaningful improvements in their ability to use their arms, hands and fingers at six months and nine months following AST-OPC1 administration,” said Dr. Richard G. Fessler, professor in the department of neurosurgery at Rush University Medical Center and lead investigator in the SCiStar Phase 1/2a study. Rush is one of six centers in the country currently studying this new approach.
The company is currently conducting its trials at six centers in the U.S., including in Los Angeles and San Jose at the Santa Clara Valley Medical Center. It seeks to expand that number to 12.
In the meantime, Asterias is testing a higher dose of 20 million AST-OPC1 cells in a separate group of spinal cord injury patients. They believe this number is the optimal dose of cells for achieving the highest motor improvement in patients.
These encouraging preliminary results have prompted the company to look ahead towards advancing their treatment down the regulatory approval pathway, out of clinical trials and into patients. Talking with the Food & Drug Administration will likely mean that Asterias will need to show further proof that their stem cell-based therapy actually improves movement in patients, rather than the patients spontaneously regaining movement (which has been observed in patients before).