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FDA Okays Trial of Donated Stem Cells for Parkinson’s

Neurons

(commonfund.nih.gov)

21 June 2021. An organization studying stem cell therapies says it received FDA authorization for a clinical trial to test donated stem cells to treat Parkinson’s disease. The mid-stage trial is funded by Hope Biosciences Stem Cell Research Foundation, a regenerative medicine philanthropy and research organization in Sugar Land, Texas.

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 20 clinical trials, including for the neurological disorders Alzheimer’s disease, traumatic brain injury, amyotrophic lateral sclerosis, and cerebral palsy.

Parkinson’s disease occurs when the brain produces less of the substance dopamine, a neurotransmitter that sends signals from one neuron or nerve cell to another. As the level of dopamine lowers, people with Parkinson’s disease become less able to control their bodily movements and emotions. Symptoms include tremors, i.e. shaking, slowness and rigidity in movements, loss of facial expression, decreased ability to control blinking and swallowing, and in some cases, depression and anxiety. According to Parkinson’s Disease Foundation, some 60,000 new cases of Parkinson’s disease are diagnosed in the U.S. each year, with more than 10 million people worldwide living with the disease.

Simultaneous trials of donated and patients’ stem cells

The clinical trial cleared by FDA is enrolling 60 participants, age 45 to 80, with mild to moderate Parkinson’s disease diagnosed in the previous two years. Patients in the trial are treated with multiple infusions of donated adipose-derived stem cells, with the study team looking for any adverse effects from the therapy and indicators of increased function and quality of life. A study protocol has not yet been posted in ClinicalTrials.gov, the U.S. government’s clinical trial repository.

The new trial is companion to a similar mid-stage Hope Biosciences study starting this month testing autologous stem cells among Parkinson’s disease patients. In that study, 24 participants are randomly assigned to receive infusions of their own stem cells or a placebo over 32 weeks, following a four-week screen period. Participants are then tracked for another 20 weeks looking primarily for adverse effects from the treatments, changes in general health, and variations in scores on a standard scale of Parkinson’s disease functions related to daily living. The study team is also monitoring measures of behavior, mood, motor activity, and complications from the therapy, as well as scores on a separate scale gauging quality of life among people with neurological diseases.

Hope Biosciences says these two studies are the first simultaneous clinical trials testing allogeneic (donated) and autologous adult stem cells on the same disease condition. “Our primary research focus has always been on autologous stem cells,” says Hope Biosciences founder and CEO Donna Chang in a foundation statement released through BusinessWire, “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.”

Chang adds, “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.”

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