IMAC Holdings, Inc. Announces Completion of First Cohort of its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease
BRENTWOOD, Tenn, March 01, 2021 (GLOBE NEWSWIRE) -- IMAC Holdings, Inc. (Nasdaq: IMAC) (“IMAC” or “the Company”), today announces it has completed the first cohort of its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinson’s disease.
The first cohort consists of five patients with bradykinesia due to Parkinson’s disease receiving a low dose, intravenous infusion of the stem cell treatment. The cohort was completed on Friday, February 26, 2021. In accordance with the trial protocol, the Company will wait at least 30 days to demonstrate safety of the low dose before initiating the second cohort in which five patients will receive a medium intravenous dose.
About IMAC’s Phase 1 Clinical Trial
The Phase 1 clinical trial, consisting of a 15-patient dose escalation safety and tolerability study, will be conducted at three of IMAC’s clinical centers in Chesterfield, Missouri, Paducah, Kentucky, and Brentwood, Tennessee. The trial will be divided into three groups: 1) five patients with bradykinesia due to Parkinson’s disease will receive a low dose, intravenous infusion of stem cells, 2) five will receive a medium intravenous dose, 3) and five will receive a high intravenous dose. All groups will be subsequently tracked for 12 months. IMAC’s medical doctors and physical therapists at the clinical sites have been trained to administer the treatment and manage the therapy. Ricardo Knight, M.D., M.B.A., who is medical director of the Mike Ditka IMAC Regeneration Center, is the trial’s principal investigator.
The Institute of Regenerative and Cellular Medicine will serve as the trial’s independent investigational review board, while Regenerative Outcomes provides management of the study. Further details of the trial can be found here.
About Bradykinesia Due to Parkinson’s Disease
In addition to unusually slow movements and reflexes, bradykinesia may lead to limited ability to lift arms and legs, reduced facial expressions, rigid muscle tone, a shuffling walk, and difficulty with repetitive motion tasks, self-care, and daily activities. Parkinson’s disease is the typical culprit of bradykinesia, and as it progresses through its stages, a person’s ability to move and respond declines.
According to Zion Market Research, the global Parkinson’s disease therapeutics market was $2.61 billion in 2018 and is expected to grow to $5.28 billion by 2025. The Parkinson’s Disease Foundation estimates that nearly 10 million people are suffering from Parkinson’s disease, and almost 60,000 new cases are reported annually in the U.S.