IMAC Holdings has completed dosing the first group of participants in a Phase 1 clinical trial evaluating its investigational umbilical cord-derived mesenchymal stem cells (MSCs) as a potential treatment for bradykinesia, a common motor symptom of Parkinson’s disease.
The group consists of five patients who received a low dose of the stem cell treatment by Feb. 26, IMAC Holdings, the therapy’s developer, announced in a press release. Researchers will wait 30 days to demonstrate the treatment’s safety before dosing the second patient group with a medium dose.
The trial is being conducted at three of IMAC’s clinical centers: Chesterfield, Missouri; Paducah, Kentucky; and Brentwood, Tennessee. More information is available here.
Bradykinesia — slowness or difficulty in movement — is one of the early signs of Parkinson’s disease. Although the mechanisms resulting in bradykinesia remain unclear, an inflammatory component seems to be involved.
Stem cells, due to their capacity to continuously divide and differentiate into various cell types, have gained interest as potential treatments in several areas, including as a regenerative medicine for neurological disorders such as Parkinson’s.
MSCs are stem cells found in multiple tissues, such as the umbilical cord, bone marrow, and fat. Because of its anti-inflammatory properties, MSCs may help to treat bradykinesia by modulating the immune system and easing inflammation.
IMAC’s open-label Phase 1 clinical trial (NCT04385056) is evaluating the safety and tolerability of escalating doses of umbilical cord-derived allogeneic mesenchymal stem cells in treating bradykinesia.
Unlike autologous stem cells that are collected from a patient’s own tissues, allogeneic stem cells are derived from a healthy donor, and used to replace a person’s diseased or damaged cells.
The study began in December and aims to recruit a total of 15 adults with Parkinson’s disease, ages 55 or older, who have been experiencing bradykinesia for at least three months before enrollment. Patients can be on a stable levodopa or other standard treatment dose.
Those enrolled will be assigned randomly to one of three dose groups — low, medium or high — and treated with a single intravenous (into-the-vein) infusion. Patients will be followed for 12 months by IMAC’s doctors and physical therapists. After each dosing group is completed, there is a waiting period of 30 days to evaluate the treatment’s safety before proceeding to the next dosing group.
Overseeing this study as lead investigator is Ricardo Knight, MD, at IMAC’s facility in Brentwood, Tennessee.
The Institute of Regenerative and Cellular Medicine acts as an independent investigational review board, while The Regenerative Outcomes Foundation is managing the study.
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