USFDAJun 22, 2026, 09:16 AM
Creative Medical's ADAPT Trial for CELZ-201 Expanded by FDA
AI Summary
Creative Medical Technology Holdings announced that the FDA has cleared an expansion of its ADAPT clinical trial for CELZ-201 (Olastrocel), targeting chronic lower back pain. The expansion adds 15 patients with ongoing but moderate opioid use, leveraging a new AI-enabled monitoring system. This follows positive interim 180-day data from the original cohort and positions the company for Phase 3 discussions with the FDA. The company expects to complete enrollment of the new cohort by the end of summer 2026 using existing resources.
Key Highlights
- FDA cleared expansion of ADAPT clinical trial for CELZ-201 (Olastrocel).
- New cohort adds 15 patients receiving less than 90 mg/day morphine equivalents.
- Expansion cohort is already more than 85% enrolled.
- Original ADAPT study enrollment completed in December 2025.
- Interim 180-day data showed statistically significant improvements in functional disability and pain.
- Trial remains supported by a favorable independent Data Safety Monitoring Board (DSMB) review.
- Company anticipates completing enrollment of expansion cohort by end of summer 2026.
- New cohort incorporates AI-driven pain medication monitoring system.
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