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MS Stem Cell Trial Receives FDA Authorization

Natan Rosenfeld Natan Rosenfeld September 10, 2021
Medically reviewed by Susan Kerrigan, MD and Marianne Madsen

Although multiple sclerosis (MS) treatment has grown by leaps and bounds in the last few decades, there’s still a long way to go. People with MS may have severe symptoms despite adhering to a medication regimen, and, even if treated, the disease can significantly impact quality of life and reduce overall life expectancy. But hope may be on the horizon in the form of a novel stem cell therapy.

 

FDA gives green light

 

The FDA recently approved a Phase II clinical trial which aims to treat MS patients using autologous adipose-derived mesenchymal stem cell infusions. The therapy, developed by Hope Biosciences Stem Cell Research Foundation (HBSCRF), isn’t a cure; rather, it’s meant to prevent the immune system from attacking itself. As MS is an autoimmune disease, it’s characterized by the immune system seeing body tissues as foreign invaders and fighting them as if it were an infection. The goal of stem cell therapy, in this case, is to attempt to restore the normal functioning of the immune system.

 

HBSCRF founder Donna Chang explains: “While this is our first study for multiple sclerosis, our focus has been on chronic neurodegenerative diseases for some time,” said Chang. “We have also been studying autoimmune diseases, and so have a deeper understanding as to how the body responds to repeated doses of mesenchymal stem cells. Current treatments for MS involve suppressing the immune system and often come with unwanted side effects.”

 

“We hypothesize that the stem cells, given in high, repeated doses, will be able to regulate the immune system so that the body stops attacking itself. Degeneration must stop in order for regeneration to be possible.”

 

The trial

 

Twenty-four patients with mild to moderate MS are expected to participate in the trial. The participants will receive a total of six stem cell infusions over 32 weeks — each infusion totaling 200 million stem cells, which are harvested from adult adipose tissue (fat). The stem cell therapy is expected to “improve symptoms and quality of life.” More specific details on the patients’ post-trial outcomes, or any potential side effects of the therapy, aren’t currently known.

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