Creative Medical Technology Holdings, Inc. announced promising initial data from the first cohort of its ongoing Phase 1/2 clinical trial for CELZ-201-DDT. This proprietary stem cell-based therapeutic is being developed for the treatment of chronic back pain caused by degenerative disc disease (DDD). The first cohort consisted of 10 participants, with 8 receiving CELZ-201-DDT and 2 receiving placebo.
The study phase for this cohort was completed without any dose-limiting toxicities or serious adverse events, indicating a favorable safety profile. Blinded preliminary data from these participants suggested encouraging therapeutic potential in alleviating back pain and restoring functionality. These early signals are important for the continued development of the therapy.
Following a comprehensive safety review, the independent Data Safety Monitoring Board (DSMB) recommended that the trial proceed to the next cohort as planned. This milestone strengthens the company's belief that CELZ-201-DDT has the potential to transform the standard of care for patients suffering from degenerative disc disease by offering a novel, non-opioid therapeutic option.
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