Creative Medical Technology Holdings Secures FDA Clearance for Expanded Dose Escalation in the Clinical Trial of CELZ-201-DDT for Chronic Lower Back Pain
PHOENIX, March 20, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) (the "Company"), a clinical-stage biotechnology company specializing in regenerative medicine, today announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded dose escalation for its ongoing Phase 1/2 trial of StemSpine® using AlloStem™ (CELZ-201-DDT), the Company's proprietary allogeneic (donor) cell therapy for chronic lower back pain caused by degenerative disc disease (DDD). This regulatory milestone follows compelling interim blinded data demonstrating statistically significant pain reduction and improved mobility among trial participants.
The first-of-its-kind study employs a minimally invasive ultrasound-guided injection of CELZ-201-DDT in an outpatient setting, with a 4:1 treatment-to-placebo ratio. With half of the trial now completed, the study has reported no dose-limiting toxicities or serious adverse events, reinforcing both the safety and potential efficacy of the therapy. The FDA's authorization allows the Company to expand dosing, further optimizing therapeutic outcomes. The Data Safety Monitoring Board (DSMB) and the Institutional Review Board (IRB) have already approved the new dosing strategy and it has been implemented.
Key Trial Milestones:
- Strong Safety Profile: No serious adverse events reported in the first half of the study.
- Encouraging Efficacy Signals: Blinded interim data demonstrates meaningful pain relief and improved mobility compared to baseline.
- Regulatory Green Light for Dose Expansion: FDA clearance secured to enhance treatment optimization.
- Continued Trial Momentum: Enrollment remains on track, with final data expected to shape future clinical and regulatory strategies.
"These promising findings continue to validate CELZ-201-DDT as a potential breakthrough, non-opioid therapy for chronic back pain," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. "The FDA's clearance of our expanded dosing strategy represents a significant step forward as we refine our approach to maximizing both safety and efficacy. If this positive data trend continues, we believe this could accelerate our pathway toward a pivotal Phase 3 trial for potential Biologics License Application (BLA) submission with the FDA."
With a commitment to advancing regenerative medicine solutions, Creative Medical Technology Holdings remains focused on delivering innovative therapies that address critical unmet needs in pain management and tissue regeneration.
About CELZ-201-DDT
CELZ-201-DDT is a proprietary allogeneic regenerative therapy designed to target the underlying pathology of DDD. Administered via ultrasound-guided injection, it offers a minimally invasive, non-surgical approach aimed at reducing pain, restoring functionality, and enhancing tissue health without exposing the patient to radiation as with other cell-based therapies.
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) is a clinical-stage biotechnology company pioneering regenerative medicine solutions for multiple indications, including pain management, neurology, and urology. The company leverages cutting-edge cell therapy technologies to develop transformative treatments aimed at improving patient outcomes.
For more information, visit www.creativemedicaltechnology.com.
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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