FDA Authorizes Simultaneous Stem Cell Trials for Parkinson’s

SUGAR LAND, Texas--(BUSINESS WIRE)--Houston area non-profit research organization Hope Biosciences Stem Cell Research Foundation (HBSCRF) has received Food and Drug Administration (FDA) 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.

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 will become the first research organization in the U.S. to conduct simultaneous trials examining effects of administering the patient’s own cells (autologous) and donor cells (allogeneic) on the same disease condition.

“We have to explore every facet of how adipose-derived mesenchymal stem cells act in this disease condition,” says HBSCRF Founder Donna Chang. “Our primary research focus has always been on autologous stem cells, but in COVID, for example, when we ran three simultaneous studies in prevention and treatment, we encountered a situation where people needed cells but did not have their stem cells banked. To serve those patients, we stepped into the world of allogeneic studies and discovered safety intact. We recognize that there is a population of patients who need help immediately and could benefit from the use of allogeneic cells. We see it as our responsibility to explore the possibilities, and we are hopeful that these trials will yield valuable information individually and as a research set.”

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 (TBI), Parkinson’s disease, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), 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 100 billion cells at zero charge to patients.

For more trial information, please call 346-900-0340.