Spinal Cord Injury: Clinical Program
Current: Phase II Trial in Cervical Spinal Cord Injury (SCI)
The majority of spinal cord injuries occur in the cervical region, which results in loss of arm and leg control. Even partial return of motor function in the arms and hands could significantly improve quality of life and support greater independence for cervical spinal cord injury patients. Patients in our Phase II trial in cervical spinal cord injury, which we call the Pathway™ Study, have the most severe degree of SCI as defined by the American Spinal Injury Association Impairment Scale (AIS), with complete loss of motor control below the level of injury, and because their injuries were sustained one to two years prior to their participation in the study, they are classified as having “chronic” SCI. The primary endpoint for the Pathway Study is to assess motor function in the upper extremities following transplantation of our HuCNS-SC human neural stem cells into the spinal cord region of injury.
In April 2015, we completed dosing of the first cohort of six patients in the Pathway Study. StemCells, Inc. safely transplanted more neural stem cells into the human spinal cord than has ever been done previously. 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. An overall pattern of improvement in both muscle strength and motor function was detected in four of the six first cohort patients, based on collective ISNCSCI and GRASSP data, six months post transplant. This is the first clinical evidence of a treatment effect improving both muscle strength and motor function in chronic spinal cord injury patients.
Learn more about the six-month interim results from Cohort 1 of the Pathway Study…
The first cohort of the Pathway Study was designed to assess the safety of cell administration into the cervical cord and select the dose level for the 40-patient second cohort, a randomized, controlled and single-blinded arm of the trial. Enrollment for the second cohort of the Pathway Study is currently underway.
Learn more about ongoing enrollment in the Pathway Study…
Completed: Phase I/II Trial in Thoracic SCI
Enrollment in this study, which transplanted patients with T2-T11 thoracic spinal cord injury, was completed in May 2014. Top-line results reported in May 2015 indicate a favorable safety profile and signs of biological activity and preliminary efficacy.
“StemCells, Inc. being controlled by a U.S. company, and the way they were following up with their patients, just made me feel safer.”
— Lance Hansen, Phase I/II SCI Clinical Trial Patient
The majority of patients participating in our Phase I/II clinical trial in thoracic SCI have yielded measurable gains involving multiple sensory modalities and spinal cord segments around and below the level of injury. Two of the seven patients enrolled with complete motor and sensory injuries (AIS A) have converted to incomplete injuries (AIS B). The onset of voluntary toe movement has also been reported by an AIS B patient one year after transplantation, which is three years post injury. These clinical observations were unanticipated at this stage following motor-complete SCI.