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FDA Clears Stem Cell Trial for Multiple Sclerosis

neurons

(NIH.gov)

27 July 2021. The Food and Drug Administration has authorized a clinical trial of stem cells extracted and cultured from patients to treat their cases of multiple sclerosis. Hope Biosciences Stem Cell Research Foundation, a not-for profit institute in Sugar Land, Texas is conducting the study cleared by FDA, announced today by the foundation.

Multiple sclerosis or MS is an autoimmune disorder, where the immune system attacks the central nervous system and damages myelin. Myelin is the fatty, protective substance around nerve fibers, as well as nerve cells themselves. Scar tissue from the damaged myelin, known as sclerosis, distorts the nerve signals sent to and from the brain and spinal cord, causing symptoms ranging from mild numbness to loss of vision or paralysis. National Multiple Sclerosis Society estimates 2.3 million people worldwide are diagnosed with MS, of which 1 million over the age of 18 live in the U.S.

Hope Biosciences supports clinical studies of stem cells as therapies for a range of disorders. The organization, started in March 2020, tests mesenchymal stem cells derived from patients’ adipose or fat tissue, also known as adult stem cells, not embryonic stem cells that raise concerns from some groups. Hope Biosciences says it already administered some 100 billion autologous stem cells — those taken from and returned to the patient — in 22 clinical trials, including for the neurological disorders Alzheimer’s disease, traumatic brain injury, amyotrophic lateral sclerosis, and cerebral palsy. As reported by Science & Enterprise in June, Hope Biosciences is also conducting a trial of stem cells to treat Parkinson’s disease.

Six infusions of 200,000 stem cells each

“Current treatments for MS involve suppressing the immune system,” says Hope Biosciences founder and CEO Donna Chang in a foundation statement released through BusinessWire, “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 mid-stage clinical trial, says Hope Biosciences, is enrolling 24 individuals with mild to moderate MS to test the treatments. Participants will receive six infusions of some 200,000 mesenchymal stem cells spaced over 32 weeks. Hope Biosciences says the research team will monitor patients to gauge changes in their symptoms and quality of life. No placebo or control group is mentioned, nor is a study protocol yet filed with ClinicalTrials.gov.

“While this is our first study for multiple sclerosis,” notes Chang, “our focus has been on chronic neurodegenerative diseases for some time. 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.”

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