Hope Biosciences’ stem cell therapy shows promise in small Phase 2 trial
Therapy led to improved scores on life-quality test for MS patients over 1 year
A mesenchymal stem cell therapy led to significant improvements in quality-of-life scores for people with multiple sclerosis (MS) in a small clinical trial, according to the treatment’s developer Hope Biosciences Research Foundation (HBRF).
“The results of this trial are groundbreaking for multiple sclerosis,” Donna Chang, president of HBRF, said in a press release from the foundation. “We believe that this positive response will translate in other autoimmune diseases in the near future.”
Mesenchymal stem cells, or MSCs, are adult stem cells found in the bone marrow, fat, and other tissues that can differentiate into bone, cartilage, and fat cells. These cells can also secrete signaling molecules to promote tissue repair and lessen inflammation.
Due to their repairing abilities, MSCs have emerged as a promising treatment approach for neurological disorders, and several MSC-based therapies have been or are being explored for MS.
Hope Biosciences’ therapy uses stem cells derived from fat tissue of patient
Hope Biosciences is studying one such cell therapy that uses adipose‑derived autologous MSCs, known as HB-adMSCs. These cells are derived from the fat tissue of the person who is undergoing treatment.
The now-completed Phase 2 trial (NCT05116540) enrolled 24 adults with relapsing remitting MS, the most common form of the disease that’s marked by relapses where symptoms worsen and periods of remission where symptoms ease. All had mild to moderate disability, but were still able to walk with or without aids.
Participants were randomly assigned to receive six infusions of HB-adMSCs or a placebo over the course of 32 weeks (about eight months). Each infusion contained 200 million cells for 1.2 billion cells in total over all the infusions.
All of the patients were followed for about one year. The study’s main goal was to evaluate how the stem cell therapy affected scores on the MS Quality of Life-54 Instrument, an assessment that measures various aspects of life quality including physical and mental health.
Patients given the HB-adMSCs treatment showed significant improvements in both physical and mental health composite scores relative to those given a placebo, according to Hope Biosciences. The foundation didn’t specify the extent of the difference between the groups, but said the effect size was large for the physical component and substantial for the mental health portion.
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,” Chang said.
Hope Biosciences also said the cell therapy was overall safe and well tolerated, without giving further details. Detailed analyses of the results are now underway.
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