Biotech Values

[TwoNE1]

STEM: StemCells, Inc. Interim Trial Data Show Motor Improvement in Patients With Cervical Spinal Cord Injury

Positive Six-Month Results, With Gains in Both Strength and Motor Function, for the First Cohort in the Phase II Pathway Study

[...]
Patients eligible for the study have 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.

This first cohort of the Pathway Study was designed to assess the safety, and preliminary signs of efficacy, 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, which is already underway.

Based on 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.

Additional highlights of the six-month interim results include:
- Muscle strength was improved in five of the six patients.
- Four of the five patients with gains in muscle strength 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.
- Based on a Patient Global Impression of Change (PGIC) assessment, four of the six patients reported that their condition had improved post-transplant.
- 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 Phase I/II thoracic study.
- No adverse events were attributed to the cells.
- The timing of the transplants ranged from ten to 23 months post-injury.

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source: https://finance.yahoo.com/news/stemcells-inc-interim-trial-data-210500169.html