The US Food and Drug Administration (FDA) has approved US-based StemCells’ investigational new drug (IND) application for clinical testing of its HuCNS-SC human neural stem cells as a treatment for spinal cord injury.
StemCells is currently involved in opening the US sites for its Phase I/II clinical trial, which is designed to assess safety and preliminary efficacy of HuCNS-SC cells as a treatment for chronic spinal cord injury, as a first action under the IND.
The Phase I/II clinical trial is already being conducted by the company in Switzerland and the trial is currently enroling patients at Balgrist University Hospital, University of Zurich.
The company is now looking forward to enroling patients at the US and Canadian sites with plans to complete enrolment by the first quarter of 2014.
The company transplanted seven patients with HuCNS-SC cells at the Balgrist University Hospital till date and now plans to enrol 12 patients with thoracic (chest-level) neurological injuries at the T2-T11 level, with the injury classified as complete or incomplete according to the American Spinal Injury Association Impairment Scale.
In the post-transplant period, patients will be assessed regularly in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to determine any change in neurological function below the injury site.
Clinical endpoints, such as changes in sensation, motor function and bowel/bladder function, will help the company determine preliminary efficacy.
Roman Reed Foundation president Roman Reed noted this is great news for the spinal cord community.
"StemCells has not seen any safety issues in the ongoing trial, and they have reported truly exciting preliminary results, with gains in sensory function persisting for 12 months after transplantation," Reed added.
With this green light from the FDA, it will be much easier for American patients to participate in this innovative trial. This is another step forward in our quest to find a cure for paralysis."
StemCells plans to follow the effects of this therapy long-term, and will invite each of the patients to enrol into a separate four-year observational study after completing the Phase I/II study.
