Hope Biosciences Announces Promising Phase II Stem Cell Therapy Results for MS

SUGAR LAND, TX, USA I October 31, 2024 I The Hope Biosciences Research Foundation (HBRF), a clinical research organization based in the Houston area, has announced encouraging top-line results from its Phase II clinical trial. This study evaluated the efficacy of Hope Biosciences’ adipose-derived autologous mesenchymal stem cell therapy (HB-adMSCs) in patients experiencing mild to moderate relapsing-remitting multiple sclerosis (MS). MS is currently an incurable disease impacting over 2 million people globally, including approximately 400,000 individuals in the United States.

The trial achieved its primary endpoint, revealing significant improvements in both physical and mental health for the treatment group when compared to the placebo group. This Phase II clinical trial (NCT05116540) was a balanced, randomized, double-blind, single-center study involving 24 participants, with 12 individuals 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 concluded after 52 weeks. The primary endpoint utilized the MS Quality of Life-54 Instrument, a comprehensive quality of life measure encompassing general and MS-specific issues such as fatigue, physical and cognitive function, sexual impairment, pain, energy, mobility, disability level, and more.

At the study’s conclusion, the HB-adMSC group exhibited a statistically significant improvement in their Physical Health Composite Scores (p<0.0001) from baseline compared to the placebo group (p<0.4856). The effect size between the groups was considerable (Cohen’s d=1.23), with a meaningful overall treatment difference (p=0.0002). Additionally, the HB-adMSC group showed a notable 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 significant overall treatment difference (p=0.016). Both groups found the treatment safe and tolerable, and a detailed analysis is currently in progress.

Donna Chang, President of HBRF, remarked on the groundbreaking nature of these results for multiple sclerosis, stating, “The trial’s findings clearly demonstrate that high doses of fresh HB-adMSCs administered regularly can yield consistent efficacy in managing a highly complex and variable condition like MS.” Chang expressed optimism that this positive outcome could extend to other autoimmune diseases in the future.

The research received partial funding from The Robert and Janice McNair Foundation. HBRF is a Texas-based nonprofit organization, categorized under 501(c)(3), and managed by the Greater Houston Community Foundation.