A Phase 2 clinical trial conducted by Hope Biosciences Research Foundation (HBRF) indicates that their mesenchymal stem cell therapy, HB-adMSCs, has shown significant promise in improving the quality of life for individuals with multiple sclerosis (MS). The trial's results suggest a potential new avenue for treating this complex neurological condition.
The study, as stated by Donna Chang, president of HBRF, demonstrated groundbreaking results for multiple sclerosis, raising hopes for similar positive outcomes in other autoimmune diseases. Mesenchymal stem cells (MSCs), known for their ability to differentiate into various cell types and secrete tissue-repairing, inflammation-reducing molecules, have been increasingly explored as a therapeutic approach for neurological disorders.
Trial Design and Key Findings
The Phase 2 trial (NCT05116540) enrolled 24 adults diagnosed with relapsing-remitting MS, the most prevalent form of the disease, characterized by alternating periods of symptom exacerbation and remission. Participants, all with mild to moderate disability but capable of walking with or without assistance, were randomized to receive either six infusions of HB-adMSCs or a placebo over a 32-week period. Each infusion contained 200 million cells, totaling 1.2 billion cells for the entire treatment course.
The primary endpoint of the study was to assess the impact of the stem cell therapy on scores from the MS Quality of Life-54 Instrument, a comprehensive tool evaluating various aspects of life quality, including physical and mental health. According to Hope Biosciences, patients receiving HB-adMSCs exhibited significant improvements in both physical and mental health composite scores compared to the placebo group. While the precise extent of the difference was not specified, the effect size was reported as large for the physical component and substantial for the mental health portion.
Safety and Tolerability
In addition to the efficacy findings, Hope Biosciences reported that the cell therapy was generally safe and well-tolerated among participants. Detailed analyses of the trial results are currently underway to further elucidate the therapy's mechanisms of action and long-term effects.
According to Chang, the results 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.
