Research & Development
FDA Authorizes Simultaneous Stem Cell Trials for Parkinson's
21 June 2021 - - Houston, US area non-profit research organization Hope Biosciences Stem Cell Research Foundation (HBSCRF) has received Food and Drug Administration authorization for a Phase II clinical trial to assess the efficacy and safety of multiple intravenous infusions of allogeneic adipose-derived mesenchymal stem cells in improving activities of daily living and quality of life in subjects with Parkinson's Disease, the organization said.

This 60-patient trial is the second FDA clinical trial authorization in Parkinson's for HBSCRF, who already has a 24-patient double-blind placebo trial underway utilizing autologous adipose-derived mesenchymal stem cells.

HBSCRF said it will become the first research organization in the US to conduct simultaneous trials examining effects of administering the patient's own cells (autologous) and donor cells (allogeneic) on the same disease condition.

Participants in the Parkinson's trial can be male or female, must be between 45-80 years of age, and must have been diagnosed with mild-to-moderate Parkinson's at least two years prior to commencement. There is no cost to participate.

To date, HBSCRF has obtained FDA authorization for 20 clinical studies in 11 disease areas, including COVID-19 prevention and treatment, Alzheimer's disease, traumatic brain injury, Parkinson's disease, amyotrophic lateral sclerosis, primary lateral sclerosis, severe osteoarthritis, both complete and incomplete spinal cord injury, Cerebral Palsy, chronic musculoskeletal pain, and lupus.

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