Hope Biosciences Research Foundation (HBRF) has announced positive top-line results from its Phase II clinical trial evaluating HB-adMSCs, an adipose-derived autologous mesenchymal stem cell therapy, for patients with mild to moderate relapsing-remitting multiple sclerosis (MS). The trial met its primary endpoint, showing statistically significant improvements in both physical and mental health compared to the placebo group.
The Phase II trial (NCT05116540) was a randomized, double-blind, single-center study involving 24 participants, with 12 in the treatment group and 12 in the placebo group. Participants received six intravenous infusions of 200 million stem cells over 32 weeks, totaling 1.2 billion cells. The study duration was 52 weeks. The primary endpoint was the MS Quality of Life-54 Instrument, assessing fatigue, physical and cognitive function, sexual impairment, pain, energy, mobility, disability level, and other factors.
Significant Improvements in Quality of Life
At the end of the study, the HB-adMSC group showed a statistically significant improvement from baseline in their Physical Health Composite Scores (p<0.0001) compared to the placebo group (p<0.4856). The effect size between the groups was large (Cohen’s d=1.23), with a significant overall treatment difference (p=0.0002). The HB-adMSC group also exhibited a significant improvement from baseline in their Mental Health Composite Scores (p<0.0042) compared to the placebo group (p<0.5724). The effect size was substantial (Cohen’s d=0.85), with a statistically significant overall treatment difference (p=0.016).
Safety and Tolerability
The treatment was reported to be safe and tolerable in both the HB-adMSC and placebo groups. Detailed analysis of the trial data is currently underway.
Expert Commentary
"The results of this trial are groundbreaking for multiple sclerosis. They clearly demonstrate that high doses of fresh HB-adMSCs delivered on a regular schedule can result in consistent efficacy in a highly complex and variable condition like MS," said Donna Chang, President, HBRF. "We believe that this positive response will translate in other autoimmune diseases in the near future."
About Multiple Sclerosis
Multiple sclerosis is a chronic, incurable autoimmune disease affecting over 2 million people worldwide, with approximately 400,000 cases in the U.S. The disease impacts the brain, spinal cord, and optic nerves, leading to a range of symptoms that can affect mobility, vision, and cognitive function.
