The U.S. FDA has granted regenerative medicine advanced therapy (RMAT) designation to Hope Biosciences’ adipose-derived mesenchymal stem cells (HB-adMSCs) for treatment of patients living with relapsing-remitting multiple sclerosis (RRMS).
The RMAT designation comes after positive top-line results in a phase 2 trial conducted at the nonprofit clinical research org, Hope Biosciences Research Foundation (HBRF), throughout 2023 and 2024 — the first trial globally to administer pure mesenchymal stem cells to MS patients in such high quantities over repeat treatments.
The trial was a balanced randomized, double-blind, single center study that enrolled 24 participants. Over the course of 32 weeks, the treatment group received six intravenous infusions of 200 million stem cells, for a total of 1.2 billion cells.
“The trial successfully met its primary endpoint, and the results clearly demonstrate that HB-adMSCs can be effective in a complex, variable condition like RRMS,” said Ridhima Vij, Ph.D., clinical research scientist, HBRF. “There were statistically significant improvements in both physical and mental health for the treatment group compared to the placebo group as determined by the MS Quality of Life-54 Instrument.”
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