Positive results have been reported from an analysis of long-term follow-up data from a phase 2 study of MultiStem stem-cell therapy (Athersys, Inc.) in patients with ischemic stroke. The data demonstrated that MultiStem-treated subjects continued to improve through one year and had a significantly higher rate of “excellent outcomes” (defined as attaining a score of 0 to 1 on the modified Rankin Scale, a score of 0 to 1 on the National Institutes of Health Stroke Scale, and a Barthel Index score of 95 or greater) compared with placebo-treated subjects (P = 0.02). The relative improvement in excellent outcomes was more pronounced in patients who received MultiStem treatment within 36 hours of a stroke (P < 0.01).
MultiStem is an “off-the-shelf” stem-cell product that may be stored for years in frozen form and is administered without tissue matching or the need for immune suppression, according to Athersys. The company is developing MultiStem stem-cell therapy for a variety of indications, with an initial focus on neurological, cardiovascular, inflammatory, and immune disorders.
Highlights from the new one-year data included the following:
Substantial improvements were also observed on the Barthel Index, a clinical scale used to assess the ability of patients to live independently. Among all of the subjects (MultiStem, n = 65; placebo, n = 61), 62% of MultiStem-treated patients had an excellent outcome (a score of 95 or greater) on the Barthel Index compared with 44% of placebo-treated patients (P = 0.05). In addition, 68% of the subset of MultiStem-treated patients who received treatment within 36 hours (n = 31) achieved an excellent Barthel Index outcome, representing a 23% difference with the incidence for all placebo-treated patients (P = 0.03).
Source: Athersys; February 17, 2016.