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
IMAC Holdings has completed the first cohort of its Phase 1 clinical trial testing umbilical cord-derived stem cells for treating bradykinesia due to Parkinson's disease. Conducted on five patients, the low dose intravenous infusion cohort concluded on February 26, 2021. Following a 30-day safety evaluation, the study will progress to mid and high dose cohorts. The trial will involve 15 patients across three sites, monitored for 12 months to assess safety and tolerability.
The global market for Parkinson’s therapeutics is projected to grow from $2.61 billion in 2018 to $5.28 billion by 2025.
- Completion of the first cohort in Phase 1 clinical trial.
- Potential market for Parkinson's therapeutics projected at $5.28 billion by 2025.
- Trial design allows for safety monitoring over 12 months.
- None.
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
About IMAC Holdings, Inc.
IMAC 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 more than 15 outpatient clinics that provide regenerative, orthopedic and minimally invasive procedures and therapies. It has partnered with several active and former professional athletes including Ozzie Smith, David Price, Mike Ditka and Tony Delk. IMAC’s outpatient medical clinics emphasize 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.
IMAC Press Contact:
Laura Fristoe
lfristoe@imacrc.com
Investor Relations:
Bret Shapiro
(516) 222-2560
brets@coreir.com
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