StemCells, Inc. has received authorization from Swissmedic, the Swiss regulatory agency for therapeutic products, to initiate a Phase I/II clinical trial in Switzerland of the Company’s proprietary HuCNS-SC product candidate in chronic spinal cord injury.
The trial is designed to assess both safety and preliminary efficacy in patients with varying degrees of paralysis who are three to 12 months post-injury, and will progressively enroll patients based upon the severity of injury. Enrollment is expected to begin in early 2011.
The trial will enroll 12 patients with thoracic (chest-level) spinal cord injury, and will include both complete and incomplete injuries as classified by the American Spinal Injury Association (ASIA) Impairment Scale. The first cohort will include patients classified as ASIA A. These patients have what is considered to be a ‘complete’ injury, or no movement or feeling below the level of the injury. The second cohort will progress to patients classified as ASIA B, or patients with some degree of feeling below the injury. The third cohort will consist of patients classified as ASIA C, or patients with some degree of movement below the injury. In addition to assessing safety, the trial will evaluate preliminary efficacy using defined clinical endpoints, such as changes in sensation, motor, and bowel/bladder function.
“This trial marks a significant broadening of our clinical development program,” said Martin McGlynn, President and CEO of StemCells, Inc. “With this authorization, we will soon have three active clinical trials evaluating our HuCNS-SC cells in conditions affecting both the brain and the spinal cord. Our current clinical investigations now target lysosomal storage disease, myelination disorders and central nervous system trauma.”
The trial will be conducted in Zurich, Switzerland at the University Hospital Balgrist, University of Zurich, one of the leading medical centers in the world for spinal cord injury and rehabilitation. The principal investigator is Armin Curt, MD, Professor and Chairman, Spinal Cord Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at the University Hospital Balgrist.