IMAC Holdings, Inc. Announces Completion of Second Cohort of its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease
February 16 2022 - 9:30AM
IMAC Holdings, Inc. (Nasdaq: IMAC) (“IMAC” or “the Company”), today
announces it has completed the second 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 second cohort consists of five patients with
bradykinesia due to Parkinson’s disease receiving an intravenous
infusion of a medium concentration stem cell treatment. The cohort
was completed on Tuesday, February 15, 2022. In accordance with the
trial protocol, the Company will wait at least 30 days to
demonstrate safety of the medium concentration dose before
initiating the third and final cohort in which five patients will
receive a high concentration intravenous dose of stem cells.
About IMAC’s Phase 1 Clinical Trial
The Phase 1 clinical trial, consisting of a
15-patient dose escalation safety and tolerability study, is being
conducted at three of IMAC’s clinical centers in Chesterfield,
Missouri, Paducah, Kentucky, and Brentwood, Tennessee. The trial is
divided into three groups: 1) five patients with bradykinesia due
to Parkinson’s disease will receive a low concentration dose,
intravenous infusion of stem cells, 2) five will receive a medium
concentration intravenous dose, 3) and five will receive a high
concentration 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 serves as the trial’s independent investigational review
board, while Regenerative Outcomes provides management of the
study. Further details of the trial can be found
at clinicaltrials.gov.
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.
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
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