Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.StemCells has announced positive six-months interim data from a Phase I/II clinical trial of its proprietary HuCNS-SC product candidate (purified human neural stem cells), designed for the treatment of chronic spinal cord injuries.
Subscribe to our email newsletter
The Phase I/II trial, which transplanted first cohort including three patients with a dose of 20 million cells at the thoracic site of injury having no neurological function, is designed to assess both safety and preliminary efficacy of HuCNS-SC product.
The trial is also designed to assess preliminary efficacy based on clinical endpoints such as changes in sensation, motor function and bowel/bladder function.
The results showed that 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.
Two of the patients were observed with changes in sensitivity to touch, heat and electrical stimuli in well-defined and consistent areas below the level of injury, while no changes were observed in the third patient.
University of Zurich Balgrist University Hospital Spinal Cord Injury Center professor and chairman Dr. Curt said the company is 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," Curt added.
The company said enrollment for the second cohort is also underway.