CELZ News & Events

Creative Medical announced results from its pilot study of Ultrasome, the company's cell-free regenerative therapy for the treatment of osteoarthritis of the knee. The study achieved its primary endpoint with 93% of patients demonstrating clinically meaningful improvements in mobility and pain reduction, with the therapy well-tolerated and no serious adverse events reported. Ultrasome is derived from the company's GMP-manufactured cell therapy product CELZ-201, which is currently being evaluated in the company's FDA-cleared ADAPT clinical trial. The company said this relationship establishes a direct connection between CELZ's clinical-stage biologic platform and its next-generation cell-free regenerative strategy, expanding the potential applications of CELZ-201 into broader, high-volume indications.

Creative Medical Technology Holding announced interim 180-day follow-up data from its FDA-cleared ADAPT clinical trial evaluating CELZ-201, the Company's proprietary perinatal tissue-derived cell therapy for chronic lower back pain associated with degenerative disc disease. The study produced statistically significant, clinically meaningful improvements in both functional disability and pain at primary trial end point, confirming durable human efficacy alongside an excellent safety profile. The announcement of this data follows a previously announced study enrollment completion and positive independent Data Safety Monitoring Board safety review, which confirmed that CELZ-201 demonstrated a favorable safety profile with no significant adverse events and supported continued advancement of the trial. Key Clinical Outcomes at Interim Analysis: ODI%: Mean improvement of -15.3 percentage points at 180 days. Approximately 79% of patients achieved clinically meaningful functional improvement. Pain: Mean reduction of -3.9 points at 180 days. Approximately 79% of patients achieved greater than or equal to2-point pain reduction. Safety: Independent DSMB review confirmed no serious adverse events and no treatment-related safety signals, remaining blinded 4:1 treatment: placebo.