Creative Medical Technology (US:CELZ) Newsfilter·2025-03-20 11:50Core Insights - The U.S. FDA has cleared an expanded dose escalation for Creative Medical Technology Holdings' ongoing Phase 1/2 trial of StemSpine® using AlloStem™ (CELZ-201-DDT), a proprietary allogeneic cell therapy for chronic lower back pain due to degenerative disc disease [1][4] - Interim blinded data shows statistically significant pain reduction and improved mobility among trial participants, reinforcing the therapy's potential efficacy [1][2][8] Trial Details - The study utilizes a minimally invasive ultrasound-guided injection of CELZ-201-DDT in an outpatient setting, with a 4:1 treatment-to-placebo ratio [2] - No dose-limiting toxicities or serious adverse events have been reported in the first half of the trial, indicating a strong safety profile [2][8] - The FDA's authorization allows for expanded dosing, which aims to optimize therapeutic outcomes [2][8] Company Perspective - The President and CEO of Creative Medical Technology Holdings emphasized that the FDA's clearance is a significant step towards maximizing safety and efficacy, potentially accelerating the pathway to a pivotal Phase 3 trial for Biologics License Application submission [4] - The company is committed to advancing regenerative medicine solutions to address critical unmet needs in pain management and tissue regeneration [4][6] Product Information - CELZ-201-DDT is designed to target the underlying pathology of degenerative disc disease, offering a non-surgical approach to reduce pain and enhance tissue health without radiation exposure [5][6] Future Outlook - Enrollment in the trial remains on track, with final data expected to influence future clinical and regulatory strategies [8]