Creative Medical Technology Expands ADAPT Trial After New FDA Clearance

Regulation
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Creative Medical Technology Holdings has received FDA clearance to expand its ADAPT clinical trial for Olastrocel, a regenerative therapy for chronic lower back pain. The amended protocol adds a cohort of 15 patients taking less than 90 mg of morphine equivalents per day to further evaluate safety and efficacy in individuals with ongoing opioid use, and enrollment in this new cohort is already more than 85% complete. The expansion follows positive interim 180-day data from the original ADAPT population showing statistically significant improvements in pain and functional disability with a favorable safety profile, and an independent Data Safety Monitoring Board recommended continued advancement. CEO Timothy Warbington said the company is now preparing for Phase 3 discussions for a broader chronic lower back pain indication, leveraging its AI-enabled pain-medication monitoring system to build a real-world data package. Creative Medical aims to position Olastrocel as a scalable, allogeneic therapy in a market still dominated by opioids, injections, and invasive surgery.

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