A new clinical trial is comparing the best available therapies to an experimental stem cell therapy to treat severe forms of relapsing multiple sclerosis (MS).
At the moment, more than a dozen therapies have been approved by the U.S. Food and Drug Administration for the treatment of relapsing forms of MS, but often the first- and second-line treatments are not effective in managing the condition for patients with a severe form of the disease.
Patients with severe relapsing MS often receive third-line biological therapies that are highly effective, but can have serious side effects.
In the new trial, called BEAT-MS — standing for BEst Available Therapy versus autologous hematopoietic stem cell transplant for Multiple Sclerosis (NCT04047628) — researchers will compare the safety, efficacy, and cost-effectiveness of two approaches: stem cell treatment and third-line therapies.
In the trial, autologous hematopoietic stem cell transplant (AHSCT), an experimental stem cell-based treatment, will involve a mixture of four chemical agents to remove the patient’s autoimmune cells that are attacking the immune system and causing MS.
Some of the patient’s healthy blood-forming stem cells will be collected before the transplant, and then infused back into the patient after the harmful immune cells have been removed. This way, the healthy stem cells can form new immune cells, and repopulate the patient’s immune system — a sort of reset of the immune system so that the central nervous system is no longer attacked.
Previous studies have suggested that AHSCT may be an effective and lasting alternative for patients with severe relapsing MS, but it had not yet been compared directly to available third-line biological therapies and can have serious side effects, including death.
“AHSCT has the potential to halt the progress of relapsing MS, eliminate the need for a person to take lifelong medication, and allow the body to partially regain function. However, we need to be certain that the benefits of this form of treatment outweigh its serious risks,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in a press release.
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