Company reaches next clinical trial
milestone for the intramuscular treatment of Chronic
Lower Back Pain with the first novel allogenic cellular therapy in
the United States
PHOENIX, Oct. 10,
2023 /PRNewswire/ -- Creative Medical Technology
Holdings, Inc. ("Creative Medical Technology" or the "Company")
(NASDAQ: CELZ), a biotechnology company focused on a regenerative
approach to immunotherapy, endocrinology, urology, gynecology, and
orthopedics, today announced that it has received Institutional
Review Board ("IRB") approval to proceed with its clinical trial
for the treatment of chronic lower back pain with its
StemSpine® procedure using AlloStem™
("CELZ-201-DDT") cell therapy.
The receipt of IRB approval is a necessary step that will allow
Creative Medical Technology to move forward with recruitment of its
recently FDA approved Phase 1 /2 randomized, double blind, placebo
controlled clinical trial to evaluate the safety, efficacy, and
tolerability of CELZ-201-DDT. The study will enroll 30
individuals suffering from chronic lower back pain caused by
Degenerative Disc Disease.
An IRB is an FDA-registered consortium that has been formally
designated to review and monitor biomedical research involving
human subjects. IRB approval is a critical and necessary
prerequisite to commencing human clinical trials and serves an
important role in the protection of the rights and welfare of human
research subjects.
"We are pleased to announce the expeditious receipt of this
vital next step in commencing the clinical trial for CELZ-201-DDT,"
said Timothy Warbington, CEO of
Creative Medical Technology. "Studies show that 8% of all adults in
the United States, approximately
16 million people, experience chronic lower back pain. The economic
impact is also significant, as a report from the National Library
of Medicine estimates that $200
billion is spent annually on the management of back pain. In
addition to limiting their daily activities and negatively
impacting their quality of life, many of those suffering rely
on opioids as the standard of care which carry their own side
effects, not the least of which is addiction. We are hopeful that
the outcome of this clinical trial will validate the efficacy,
safety, and endurance of CELZ-201-DDT as a non-surgical treatment
option for chronic lower back pain."
About CELZ-201-DDT
CELZ-201-DDT is a patented procedure that utilizes an "off the
shelf, ready-to-use" universal and proprietary allogenic (donor)
cell line developed by the Company and trademarked as
AlloStem™. Using an ultrasound guided, non-surgical
procedure, AlloStem™ is injected in areas
surrounding the diseased disc(s), thereby potentially repairing,
remodeling, and improving the blood supply around the disc and
lower back area, without exposing the patient to radiation as with
other cell-based procedures. CELZ-201-DDT distinguishes itself by
using a unique immunomodulatory formula derived from
allogeneic perinatal cells, which in preliminary studies have shown
potential for tissue repair and changing cytokine profiles.
Details on the clinical trial may be found
here: NCT06053242.
About Creative Medical Technology Holdings
Creative
Medical Technology Holdings, Inc. is a biotechnology company
dedicated to the advancement of identifying and translating novel
immediately deployable FDA registered biological therapeutics in
the fields of immunotherapy, endocrinology, urology,
gynecology and orthopedics and is traded on NASDAQ under the ticker
symbol CELZ. For further information about the Company, please
visit www.creativemedicaltechnology.com.
Special Note Regarding Forward Looking
Statements
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accept responsibility for the adequacy or accuracy of this release.
This news release may contain forward-looking statements including
but not limited to comments regarding the timing and content of
upcoming clinical trials and laboratory results, marketing efforts,
funding, etc. Forward-looking statements address future events and
conditions and, therefore, involve inherent risks and
uncertainties. Actual results may differ materially from those
currently anticipated in such statements. See the periodic and
other reports filed by Creative Medical Technology Holdings, Inc.
with the Securities and Exchange Commission and available on the
Commission's website at www.sec.gov.
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SOURCE Creative Medical Technology Holdings, Inc.