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
Rhea-AI Summary
Creative Medical Technology Holdings announced a successful independent interim safety review by the Data Safety Monitoring Board (DSMB) for its ADAPT clinical trial of CELZ-201, a perinatal tissue derived cell product for chronic lower back pain treatment. The DSMB reviewed safety data from the first five dosed patients and approved trial continuation, following a 30-day dose-limiting toxicity assessment. The ADAPT trial is a double-blind, randomized, placebo-controlled, dose-escalation study evaluating CELZ-201's safety and efficacy when administered intramuscularly. The treatment targets approximately 16 million US patients suffering from chronic lower back pain associated with degenerative disc disease.
Positive
- DSMB approved continuation of ADAPT clinical trial after safety review
- Successfully completed 30-day dose-limiting toxicity assessment for first five patients
- Treatment addresses large market of 16 million US patients with chronic lower back pain
Negative
- None.
PHOENIX, Nov. 13, 2024 (GLOBE NEWSWIRE) -- 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 Statements
This 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 | Investor Relations Devin Sullivan, Managing Director The Equity Group Inc. dsullivan@equityny.com Conor Rodriguez, Analyst crodriguez@equityny.com |
FAQ
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