The Biotechnology company StemCells, Inc. announced that the first patient in the company’s Phase 1/2 clinical trial to treat chronic spinal cord injury was successfully transplanted with the company’s HuCNS-SC adult neural stem cells. These stem cells were administered at Balgrist University Hospital, University of Zurich and the transplant surgery was performed by a team of surgeons led by Raphael Guzman, MD, a visiting staff neurosurgeon also on faculty at department of neurosurgery, Stanford University, and K. Min, MD, an orthopedic surgeon at Balgrist University Hospital.
The first patient transplanted in the trial is a 23-year-old German man, who suffered a spinal cord injury in an automobile accident in April, 2011. This gentleman sustained a complete loss of sensation and mobility from the waist down. Stephen Huhn MD, FACS, FAAP, vice president and head of the CNS program at StemCells Inc said “With this first patient enrolled and dosed, we remain on track to meet our goal of treating the first cohort of patients by the end of this year. While the trial’s first cohort will consist of patients with the most severe, complete injury, the second and third cohorts will progress to patients with less severe, incomplete injury. This unique trial design will allow us to evaluate the potential of our HuCNS-SC cells as a treatment for a broad spectrum of spinal cord injury patients. Even a small improvement could have a marked impact on quality of life for the millions of people who suffer from this debilitating condition.”
StemCells Inc’s phase I/II clinical trial of their HuCNS-SC purified human adult neural stem cell line is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned to be enrolled in this exciting trial. The first three patients will all have injuries classified as ASIA A, in which there is no apparent neurological function below the injury level, the most severe level identified by the American Spinal Injury Association (ASIA) Impairment Scale. The second and third cohorts will be patients classified as ASIA B and ASIA C, those with less severe injury, in which there is some preservation of sensory or motor function. In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function.
All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be receive temporary suppression of the immune system to ensure that the transplanted cells are not rejected by the patient’s immune system. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The company intends to follow the effects of this therapy long-term, and a separate 4-year observational study will be initiated at the conclusion of this trial.