Cells and Procedure Well Tolerated; Gains in Sensory Function Confirmed
STEM announced that interim 6 month data from the 1st patient cohort in its P1/2 clinical trial of its HuCNS-SC® product candidate (purified human neural stem cells) for chronic spinal cord injury continues to demonstrate a favorable safety profile, and shows considerable gains in sensory function in 2 of the 3 patients compared to pre-transplant baselines. The 3rd patient remains stable.
The data was presented by Armin Curt, MD, principal investigator for the clinical trial, at the 51st Annual Scientific Meeting of the International Spinal Cord Society in London, England. The trial represents the 1st time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury.
Patients in the study's 1st 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. All 3 patients were transplanted 4 to 9 months after injury with a dose of 20M cells at the site of injury. The surgery, immunosuppression and the cell transplants have been well tolerated by all the patients. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients were neurologically stable through the first six months following transplantation. Changes in sensitivity to touch, heat and electrical stimuli were observed 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.
The Bottom Line: In the 3 month assessments, 3 patients have tolerated the cell transplantation very well, and have no safety concerns at this point. 2 of the 3 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. This is the first time a sensory change of this magnitude has been reported in patients with complete spinal cord injury following stem cell transplantation. STEM will need to collect more data to establish efficacy and is pushing ahead with the trial and plans to dose the 1st patient with an incomplete injury soon.
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