Creative Medical Technology Holdings, Inc. (CELZ), on Thursday announced that the FDA has cleared an expanded dose escalation for its Phase 1/2 clinical trial of CELZ-201-DDT or StemSpine using AlloStem, an allogeneic stem cell therapy for chronic lower back pain caused by degenerative disc disease or DDD.
Key Takeaways from the Announcement:
-- Positive interim blinded data shows statistically significant pain reduction and improved mobility.
-- No serious adverse events or dose-limiting toxicities were reported, reinforcing safety and potential efficacy.
-- FDA approval for expanded dosing to optimize treatment effectiveness.
Final trial data will shape future regulatory strategies, with the potential for a Phase 3 pivotal trial leading to Biologics License Application or BLA submission.
The FDA's decision allows Creative Medical Technology Holdings to increase the treatment dose, potentially enhancing patient outcomes.
If positive trends continue, the company could move closer to a Phase 3 trial and potential FDA approval.
CELZ-201-DDT is a minimally invasive, non-opioid, ultrasound-guided cell therapy designed to reduce pain, restore function, and improve tissue health in chronic lower back pain patients.
Currently, CELZ is trading at $2.93 down by 3.13 percent on the Nasdaq.
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