FDA Grants RMAT Designation to Hope Biosciences’ Cell Therapy for Multiple Sclerosis

SILVER SPRING, MD- August 28, 2025 — The U.S. Food and Drug Administration (FDA) has awarded Regenerative Medicine Advanced Therapy (RMAT) designation to Hope Biosciences’ cell therapy, which uses adipose-derived mesenchymal stem cells (HB-adMSCs) for treating relapsing-remitting multiple sclerosis (RRMS).

The decision was based on promising top-line results from a Phase II trial conducted by the Hope Biosciences Research Foundation (HBRF). This study, which enrolled 24 subjects, was a significant step in the field, marking the first time worldwide that MS patients had repeatedly received such high doses of pure mesenchymal stem cells as a cell therapy.

Over the 32-week trial, participants received a total of six intravenous infusions, each containing 200 million stem cells, for a cumulative dose of 1.2 billion cells. The trial employed a randomized, double-blind method at a single center.

RMAT status is a key regulatory milestone, granted to therapies that show initial clinical evidence of addressing serious or life-threatening conditions with an unmet medical need. Hope Biosciences’ HB-adMSCs have been used as a cell therapy in over 50 clinical studies and expanded access programs authorized by the FDA, treating patients ranging from 18 months to over 90 years old for a variety of conditions.

Hope Biosciences CEO Donna Chang hailed the designation as “a tremendous acknowledgment of our technology’s potential to impact the world of debilitating autoimmune conditions.” She also credited HBRF for its “unparalleled expertise” and “pioneering, patient-centered protocols” in advancing the therapy.