Positive Interim Blinded Data Supports Advancement Toward Potential Pivotal Phase 3 Study
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.
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.
Contact:
Creative Medical Technology Holdings, Inc.
IR@CreativeMedicalTechnology.com
Investor Relations:
Devin Sullivan, Managing Director
The Equity Group Inc.
Conor Rodriguez
Associate
