Two of three patients in a phase I/II clinical trial of stem cells for chronic spinal cord injury have shown considerable gains in sensory function, according to Armin Curt, M.D., principal investigator who presented results at the 51st Annual Scientific Meeting of the International Spinal Cord Society in London, England. The three patients received injections of StemCells, Inc.’s HuCNS-SC purified human adult neural stem cells. Doctors transplanted three patients with a dose of 20 million cells at the site of injury four to nine months after their injuries took place.
“As with the three-month assessments, these three patients have tolerated the cell transplantation very well, and we have no safety concerns at this point, ” said Curt, professor and chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich. “We are very intrigued to see that two of the three patients have gained considerable sensory function. The gains in sensation have evolved in a progressive pattern below the level of injury and are unanticipated in spinal cord injury patients with this severity of injury, suggesting that the neural stem cells are having a beneficial clinical effect. Sensory function of all these patients was stable before transplantation, so the reappearance of sensation is rather unexpected.”
Stephen Huhn, M.D., Vice President of StemCells, Inc. added, “To see this kind of change in patients who truly have the worst-of-the-worst type of injury to the spinal cord is very exciting. To our knowledge, this is the first time a sensory change of this magnitude has been reported in patients with complete spinal cord injury following a stem cell transplantation. We clearly need to collect more data to establish efficacy, but we are encouraged. We are pushing ahead with our trial and plan to dose the first patient with an incomplete injury soon.”
Patients in the study’s first cohort all suffered a complete injury to the thoracic (chest-level) spinal cord. In a complete injury, there is no neurological function below the level of injury. Researchers observed changes in sensitivity to touch, heat and electrical stimuli in well-defined and consistent areas below the level of injury in two of the patients, while no changes were observed in the third patient. Tests of perception of different sensory stimuli as well as measures of electrical impulse transmission across the site of injury correlate with the clinical examination, providing independent and objective confirmation of the changes in sensory function.
Researchers are conducting the trial at Balgrist University Hospital, University of Zurich, a leading medical center for spinal cord injury and rehabilitation. The trial, now underway for the second cohort, is open for enrollment to patients in Europe, Canada and the United States. Those interested in participating in the study, should contact the study nurse either by phone at +41 44 386 39 01 or by email.
