After six months, the patients in the StemCells, Inc. trial being conducted at University of Miami Hospital are demonstrating improvements in both strength and function. They are the first cohort in the Phase II pathway study, led by Allan D. Levi, M.D., Ph.D., professor and Chair of the Department of Neurological Surgery and The Miami Project to Cure Paralysis, which is measuring the effects of implanting stem cells in patients with cervical spinal cord injury (SCI). The assessment of motor function involved using tests of dexterity and grip.
Levi, who is also Chief of Neurosurgery at Jackson Memorial Hospital, 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 help determine the dose level for the 40-patient second cohort — a randomized, controlled and single-blinded arm of the trial, which is already underway.
“The safety of the procedure with increasing doses of stem cells is one of the first important observations of this trial,” said Levi.
The patients in the 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. Clinicians used both International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and Graded Assessment of Strength Sensibility and Prehension (GRASSP) 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.
“Any improvement in motor function is incredibly important to this patient population, and as a researcher and clinician is very exciting to observe,” said Levi.
Additional highlights of the 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 in 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,” 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. “These findings are even more compelling given that all the patients are between one and two years post-injury.”