Houston-area clinical research organization Hope Biosciences Research Foundation (HBRF) today shares positive top-line results of a Phase II clinical trial to evaluate Hope Biosciences’ adipose‑derived autologous mesenchymal stem cell therapy (HB-adMSCs) for patients with mild to moderate relapsing remitting multiple sclerosis (MS), a disease currently considered incurable that affects more than 2 million people worldwide and approximately 400,000 in the U.S.

The trial successfully met its primary endpoint, demonstrating statistically significant improvements in both physical and mental health for the treatment group compared to the placebo group. The Phase II clinical trial (NCT05116540) is a balanced randomized, double-blind, single center study that enrolled 24 participants, 12 in the treatment group and 12 in the placebo. The study mandated six intravenous infusions of 200 million stem cells over the course of 32 weeks, for a total of 1.2 billion cells. End of study was 52 weeks. The primary endpoint was the MS Quality of Life-54 Instrument, a multidimensional quality of life measure that combines general and MS-specific points related to fatigue, physical and cognitive function, sexual impairment, pain, energy, mobility, level of disability, and other considerations.

At end of 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). Treatment was safe and tolerable in both groups. Detailed analysis is now underway.

“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,” says Donna Chang, President, HBRF. “We believe that this positive response will translate in other autoimmune diseases in the near future.”

This research was made possible in part by the generous support of The Robert and Janice McNair Foundation. Texas-based HBRF is a 501(c)(3) nonprofit organization administered by the Greater Houston Community Foundation.

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