Policy & Regulation
FDA Gives Green Light for Multiple Sclerosis Stem Cell Trial
28 July 2021 - - US-based non-profit research organization Hope Biosciences Stem Cell Research Foundation (HBSCRF) has received FDA authorization for a randomized, double-blind, single center, Phase II clinical trial to assess the efficacy of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells in improving symptoms and quality of life in patients with mild-to-moderate multiple sclerosis, the company said.

Twenty-four patients will report to HBSCRF for six infusions over 32 weeks.

A single infusion in the treatment group consists of 200 m stem cells, or approximately 1.2bn stem cells per patient over the course of study.

HBSCRF remains the only organization globally to administer pure, fresh mesenchymal stem cells, an adult stem cell harvested from fat, in such high quantities over repeat treatments.

More than 2m people worldwide and 400,000 people in the US suffer from MS. In MS, the immune system attacks myelin, a protective sheath around nerve fibers.

Symptoms are diverse, depending on which nerves are damaged and to what degree. Developmental timelines also vary, ranging from periods of remission to loss of ability to walk.

HBSCRF exists to revolutionize medicine by accelerating translational research in regenerative medicine to develop cures for all.

To date, HBSCRF has obtained FDA authorization for 22 clinical studies in 12 disease areas. Clinical trial authorizations encompass COVID-19 prevention and treatment, traumatic brain injury, Parkinson's disease, and multiple sclerosis.

Expanded access protocols include amyotrophic lateral sclerosis, primary lateral sclerosis, severe osteoarthritis, spinal cord injury, cerebral palsy, chronic musculoskeletal pain, lupus, and COVID-19 Longhaulers.

Launched in March 2020, in its first year of operation HBSCRF administered nearly 100 bn cells at zero charge to patients.
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