IMAC Holdings, Inc. Announces Opening Enrollment in Its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease
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IMAC Holdings, Inc. Announces Opening Enrollment in Its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease
BRENTWOOD, Tenn, Nov. 05, 2020 (GLOBE NEWSWIRE) -- IMAC Holdings, Inc. (Nasdaq: IMAC) (“IMAC” or “the Company”), a provider of innovative medical advancements and care specializing in regenerative rehabilitation orthopedic treatments without the use of surgery or opioids, today announces it is opening enrollment in its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia, or the gradual slowing and loss of spontaneous body movement, due to Parkinson’s disease.
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, and all groups will be 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.
“This is a pivotal moment in the history of IMAC as it expands its business beyond that of its regenerative medicine, physical therapy and rehabilitation model and further pursues non-opioid, non-surgical, medical solutions for movement-restricting diseases. This process began with the idea to apply stem cell treatment to Parkinson’s patients for whom physical therapy alone was not sufficient to provide restoration of movement and alleviation of pain. Moreover, utilizing our existing centers and our knowledge of their communities helps streamline the costs usually associated with conducting these types of studies,” said Jeffrey Ervin, IMAC Chief Executive Officer. “The enrollment process and the subsequent first dose is expected to be administered by the end of 2020. We have already received considerable interest from Parkinson’s patients who would like to participate in the trial and expect to fill enrollment in a relatively short time. We look forward to the opportunity to share the outcome from the trial in the coming year.”
The Institute of Regenerative and Cellular Medicine will serve as the trial’s independent investigational review board while Regenerative Outcomes will provide management of the study. Further details of the trial can be found here.
In addition to unusually slow movements and reflexes, bradykinesia can also 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.
About IMAC Holdings, Inc.
IMAC Holdings was created in March 2015 to expand on the footprint of the original IMAC Regeneration Center, which opened in Kentucky in August 2000. IMAC Regeneration Centers combine life science advancements with traditional medical care for movement restricting diseases and conditions. IMAC owns or manages 15 outpatient clinics that provide regenerative, orthopedic and minimally invasive procedures and therapies. It has partnered with several active and former professional athletes, opening six Ozzie Smith IMAC Regeneration Centers, two David Price IMAC Regeneration Centers, as well as Mike Ditka IMAC Regeneration Centers and a Tony Delk IMAC Regeneration Center. IMAC’s outpatient medical clinics emphasize its focus around treating sports and orthopedic injuries and movement-restricting diseases without surgery or opioids. More information about IMAC Holdings, Inc. is available at www.imacregeneration.com.
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Safe Harbor Statement
This press release contains forward-looking statements. These forward-looking statements, and terms such as “anticipate,” “expect,” “believe,” “may,” “will,” “should” or other comparable terms, are based largely on IMAC's expectations and are subject to a number of risks and uncertainties, certain of which are beyond IMAC's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the skills and experience necessary to meet customers’ requirements, and its ability to protect its intellectual property. IMAC encourages you to review other factors that may affect its future results in its registration statement and in its other filings with the Securities and Exchange Commission. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this press release will in fact occur.
