PHOENIX, Sept.
19, 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 the U.S. Food and Drug
Administration ("FDA") has cleared the Company to proceed with a
Phase 1/2 clinical trial of StemSpine® using
AlloStem™ ("CELZ-201-DDT").
The study is designed to evaluate the safety, efficacy, and
tolerability of CELZ-201-DDT. The study will enroll 30 individuals
suffering from chronic lower back pain. 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.
"The FDA's clearance allowing us to pursue this clinical trial
is a milestone event for Creative Medical Technology and a
validation of our commitment to developing and advancing novel
regenerative therapeutics that can improve patient lives," said
Timothy Warbington, CEO of Creative
Medical Technology. "An estimated 20% of Americans suffer from
chronic lower back pain, with many of these individuals relying on
opioids as the standard of care for relief. With an opioid crisis
in the United States, we believe
that CELZ-201-DDT is potentially a more effective, sustainable, and
safer non-surgical pain management option compared to opioids, and
we look forward to advancing these studies."
"Chronic lower back pain is an increasing cause of disability
globally," noted Courtney Bartlett,
Director of Clinical Development. "This clinical trial sets the
foundation to potentially help patients with a safer alternative
therapy for chronic lower back pain as the procedure can be
performed in the outpatient setting under direct ultrasound
guidance, without any radiation exposure."
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. is a biotechnology
company dedicated to the advancement of identifying and translating
novel 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.
About StemSpine Inc.
StemSpine Inc. is a wholly owned subsidiary of Creative Medical
Technology Holdings Inc., concentrating on Orthopedic Medicine,
including spine, knees, shoulders and joints.
Forward Looking Statements
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.