Positive Six-Month Results, with Gains in Both Strength and Motor Function, for the First Cohort in the Phase II Pathway Study
Allan Levi, M.D., Ph.D., FACS, Professor and Chairman, Department of Neurological Surgery and The Miami Project to Cure Paralysis, Chief of Neurosurgery, Jackson Memorial Hospital is a lead investigator in the StemCells Inc. trial which is being conducted at the University of Miami Hospital. The company recently announced that the six-month interim results for the first cohort in its ongoing Phase II Pathway™ Study in cervical spinal cord injury (SCI) showed motor improvements in both strength and function. The assessment of motor function involved using tests of dexterity and grip.
Dr. Levi was the first investigator to perform a stem cell transplant into the chronically injured cervical spinal cord of a patient. This first cohort of the study was designed to assess the safety, and preliminary signs of efficacy, of cell administration into the cervical spinal cord and select the dose level for the 40-patient second cohort, a randomized, controlled and single-blinded arm of the trial, which is already underway. Dr. Levi indicated that the “The safety of the procedure with increasing doses of stem cells is one of the first important observations of this trial.”
The patients in this study were selected because they had complete loss of motor control below the level of injury, the most severe degree of SCI as defined by the American Spinal Injury Association Impairment Scale (AIS). Clinicians used both ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) and GRASSP (Graded Assessment of Strength Sensibility and Prehension) measures to establish a pre-transplant baseline for each patient, and to assess post-transplant progress.
Based on the six-month follow-up for the first cohort, an overall pattern of motor improvement was detected in four of the six patients as measured by gains in both strength and function on the collective ISNCSCI and GRASSP outcomes. Dr. Levi noted “Any improvement in motor function is incredibly important to this patient population and as a researcher and clinician is very exciting to observe.”
Additional highlights of these six-month interim results include improved muscle strength in five of the six patients, with four of the five patients having gains in muscle strength and also demonstrated improved performance on functional tasks assessing dexterity and fine motor skills. Four of the six patients had improvement in the spinal level of injury as defined by the ISNCSCI assessment; three upgraded one level and one upgraded two levels. Additionally, changes in muscle strength and function were observed around three months post-transplant, consistent with the onset of sensory improvements seen in the Company’s initial Phase I/II thoracic study, and no adverse events were attributed to the cells.
“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,” said Armin Curt, M.D. the principal investigator at the University of Zurich for the Company’s previous Phase I/II thoracic spinal cord injury study.