Creative Medical Technology Holdings, Inc. 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). This proprietary allogeneic cell therapy is being developed for chronic lower back pain caused by degenerative disc disease (DDD).
This regulatory milestone follows compelling interim blinded data that demonstrated statistically significant pain reduction and improved mobility among trial participants. Half of the trial has now been completed, with no dose-limiting toxicities or serious adverse events reported, reinforcing both the safety and potential efficacy of the therapy. The Data Safety Monitoring Board (DSMB) and the Institutional Review Board (IRB) have already approved and implemented the new dosing strategy.
Management believes that if this positive data trend continues, the FDA’s authorization for expanded dosing could accelerate the pathway toward a pivotal Phase 3 trial for potential Biologics License Application (BLA) submission. This development represents a significant step forward in refining the approach to maximizing both safety and efficacy for this potential breakthrough, non-opioid therapy.
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