Interim data in stem cell trial for cervical spinal cord injury demonstrate motor improvement
StemCells, Inc.’s Phase II clinical trial of human neural stem cell transplantation for traumatic cervical spinal cord injury has demonstrated positive results in patients’ strength and motor function in the first cohort at 6 months.
StemCells, Inc. has announced the 6-month interim results of the first cohort in its ongoing Phase II study of their proprietary human neural stem cell (HuCNS-SC cell) product for trauma-induced cervical spinal cord injury patients with complete loss of motor control below the level of injury.
The first cohort of the study is aimed at analyzing the safety and preliminary signs of efficacy of the cell transplantation, which is administered into the cervical cord, and selecting the dose level for the 40-patient second cohort, which is already underway. An overall pattern of motor improvement in terms of strength and function was detected in four of the six patients from this first cohort, according to International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and GRASSP (Graded Assessment of Strength Sensibility and Prehension) outcomes.
“The early analyses of motor improvement from the first cohort of the Pathway Study are consistent with an evolution of the sensory outcomes seen in StemCells’ previous thoracic study,” stated Armin Curt, the principal investigator at the University of Zurich for the Company’s previous Phase I/II thoracic spinal cord injury study. “The emerging data are the first clinical evidence of a treatment effect improving muscle strength and function following cellular transplant in spinal cord injuries. These findings are even more compelling given that all the patients are between one and two years post injury.”
An effective therapy for spinal cord injury would have a significant positive impact on patients’ quality of life. “We do not expect to see spontaneous recovery in spinal cord injury patients more than a year after their injury,” explained StemCells’ CMO and Vice President, Clinical Research, Stephen Huhn. “The improvements in upper extremity muscle strength and function can be seen in specific tasks such as opening a jar, picking up coins or grasping and turning a key. Gaining the ability to perform these simple tasks should result in more independence and an improved quality of life for those impacted by spinal cord injuries.”
The primary measure of efficacy of the study will be change in upper extremity strength as measured in the hands, arms and shoulders, and the trial aims to enroll a total of approximately 52 subjects and follow the patients for 12 months post-transplant.