Creative Medical Technology Holdings, Inc.

Positive Interim Blinded Data Supports Advancement Toward Potential Pivotal Phase 3 StudyPHOENIX, 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 HoldingsCreative 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 StatementsThis 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 DirectorThe Equity Group Inc.dsullivan@equityny.com Conor RodriguezAssociatecrodriguez@equityny.com

Feb. 14, 2025 -- Creative Medical Technology Holdings, Inc. ("Creative Medical Technology" or the "Company") (NASDAQ: CELZ), a pioneering biotechnology firm specializing in regenerative medicine solutions for immunotherapy, endocrinology, urology, gynecology, and orthopedics, today announced compelling mid-term follow-up data from its StemSpine® pilot study utilizing its AlloStem™ cells for the treatment of chronic lower back pain. The pilot study demonstrated a substantial reduction in opioid dependency and significant improvements in pain levels and functional mobility. Notably, over 90% of patients reported no opioid use for pain management three years post-procedure, with an 80% persistent reduction in pain scores and a greater than 60% improvement in Oswestry Disability Index scores. Only one patient required reintervention at the three-year follow-up mark, and no serious adverse events were reported, reinforcing the favorable safety profile of the StemSpine® procedure. StemSpine® is a proprietary, patented, non-surgical, ultrasound-guided procedure that leverages AlloStem™, an "off-the-shelf" allogenic (donor-derived) cell therapy developed by the Company. The StemSpine® patent encompasses the use of both autologous (patient-derived) and allogenic cells, broadening its clinical utility. "Opioid dependency remains a pressing concern for individuals suffering from chronic lower back pain," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. "These results underscore the safety and clinical efficacy of AlloStem™ in the StemSpine® procedure by promoting repair, remodeling, and improved vascularization in the affected areas. This promising data supports our vision of providing innovative, non-surgical solutions for millions of Americans struggling with chronic lower back pain.” The StemSpine pilot study data is independent of the Company’s ongoing FDA-cleared Phase 1/2 ADAPT clinical trial of CELZ-201-DDT for chronic lower back pain; however, these compelling findings continue to drive strong enrollment in the prospective, randomized, double-blind, dose-escalation ADAPT study, further reinforcing StemSpine® as a groundbreaking advancement in regenerative medicine. Study Details | Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain | ClinicalTrials.gov 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. The content above comes from the network. if any infringement, please contact us to modify.

Feb. 11, 2025 -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company advancing regenerative medicine solutions, today announced promising one-year follow-up data from the AlloStem ™ (CELZ-201) Type 2 Diabetes pilot study for late-stage patients. CELZ-201 is an off the shelf, ready-to-use universal and proprietary allogenic (donor) cell line developed by the Company. Results demonstrate that CELZ-201 achieved an 80% overall efficacy rate in reducing insulin dependency and stabilizing hemoglobin A1c levels, with no serious adverse effects reported. The study, which included 20 patients—10 receiving CELZ-201 and 10 undergoing optimized medical therapy—validated the safety and efficacy of CELZ-201 through the same infusion procedure used in the Company’s U.S. FDA-cleared Type 1 Diabetes clinical trial, which is currently underway. The absence of safety concerns further supports the potential of CELZ-201 as a breakthrough treatment for late-stage Type 2 Diabetes. Given these compelling results, Creative Medical Technology plans to advance the development of AlloStem (CELZ-201) for the treatment of late-stage Type 2 Diabetes and explore other potential applications of this therapy to expand the Company’s pipeline. "The positive one-year data from the study represents a significant milestone in our mission to revolutionize diabetes treatment and help a wide variety of patients who potentially may not benefit from autologous therapies," said Timothy Warbington, President and CEO of Creative Medical Technology. "With a diversified portfolio that includes CELZ-201 for early-stage Type 1 Diabetes, CELZ-101 for brittle Type 1 Diabetes, and CELZ-201 for late-stage Type 2 Diabetes, we are committed to delivering innovative solutions that transform patient care." Type 2 diabetes affects approximately 90-95% of the 38 million Americans diagnosed with diabetes. While initially managed through diet, exercise, and oral medications, many patients eventually require insulin therapy as the disease progresses. Diabetes remains the eighth leading cause of death in the U.S., with over 96 million adults classified as prediabetic—more than 80% of whom are unaware of their condition. Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company dedicated to developing groundbreaking regenerative cell therapies. The company’s pipeline targets a range of conditions, with a focus on endocrinology, immunotherapy, orthopedic and neurological diseases. The content above comes from the network. if any infringement, please contact us to modify.