Creative Medical Technology Holdings, Inc. Advances FDA Cleared ADAPT Clinical Trial with Positive Independent Review, Validating the Safety and Potential of CELZ-201 for Chronic Lower Back Pain Treatment
November 13 2024 - 8:00AM
Creative Medical Technology Holdings,
Inc. (NASDAQ: CELZ), a biotechnology leader in
regenerative medicine, is pleased to announce the successful
completion of an independent interim safety review by the Data
Safety Monitoring Board (DSMB) for its ADAPT clinical trial. The
trial evaluated CELZ-201, a novel therapeutic perinatal tissue
derived cell product, designed to treat chronic lower back pain
associated with degenerative disc disease.
The DSMB reviewed safety data from the first five dosed patients
concluding that the trial may proceed as planned, underscoring the
safety profile of CELZ-201 and supporting the advancement of this
innovative therapy. This positive review follows the completion of
a rigorous 30-day dose-limiting toxicity (DLT) assessment per
patient, an important milestone as CELZ-201 moves closer to
potentially transformative therapeutic outcomes for patients.
“The DSMB’s positive review marks an exciting and
validating moment for Creative Medical Technology,”
commented Timothy Warbington, CEO of Creative Medical Technology
Holdings, Inc. “As we push forward and accelerate
enrollment, the ADAPT trial continues to demonstrate not only the
commitment of our team but also the potential of CELZ-201 to
significantly address chronic lower back pain—a condition with
limited long-term solutions for 16 million patients in the United
States. This validation fuels our confidence in the safety and
viability of our regenerative biologic approach, and we look
forward to advancing towards the next stages of clinical
development.”
The ADAPT trial (CELZ-201-ADAPT-2023) is a double-blind,
randomized, placebo-controlled, dose-escalation study designed to
rigorously evaluate the safety, tolerability, and efficacy of
CELZ-201 administered intramuscularly using minimally invasive
ultrasound techniques. The trial employs careful, protocol-driven
monitoring of adverse events in alignment with Common Terminology
Criteria for Adverse Events (CTCAE v.5), safeguarding patients and
providing real-time data for DSMB review and study continuity.
Regular DSMB reviews are scheduled to ensure ongoing compliance
with safety standards, reinforcing CELZ-201’s clinical
potential.
Creative Medical Technology Holdings continues to pursue
cutting-edge therapies within its regenerative medicine and
immunotherapy pipeline, pioneering safe, effective treatments for
high-need indications. CELZ-201 exemplifies the company’s mission
to develop targeted cellular therapies, combining rigorous science
with strategic clinical insights to tackle previously unmet medical
needs.
About Creative Medical Technology Holdings,
Inc. Creative Medical Technology Holdings, Inc. (NASDAQ:
CELZ) is a clinical-stage biotechnology company pioneering
regenerative medicine therapies derived from adult stem cells. With
a robust therapeutic platform, the Company is at the forefront of
innovative solutions for degenerative diseases, committed to
delivering transformative treatments for patients. Creative Medical
Technology Holdings is dedicated to translating its scientific
advancements into accessible, impactful care.
For more information, visit
www.creativemedicaltechnology.com.
Forward-Looking StatementsThis press release
contains forward-looking statements as defined under the Private
Securities Litigation Reform Act of 1995. Statements may include
predictions, forecasts, or indications of future results and are
based on information available as of the date hereof.
Forward-looking statements are subject to risks and uncertainties,
including those detailed in Creative Medical Technology Holdings'
filings with the Securities and Exchange Commission.
Company Contact
Creative Medical
Technology
IR@CreativeMedicalTechnology.com
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