Core Insights - Creative Medical Technology Holdings, Inc. announced promising initial data from its Phase 1/2 clinical trial of CELZ-201-DDT, a stem cell-based therapy for chronic back pain due to degenerative disc disease [1][2] - The first cohort of 10 participants completed the study without any dose-limiting toxicities or serious adverse events, indicating a strong safety profile [2][8] - Preliminary blinded data suggests potential therapeutic benefits in alleviating back pain and restoring functionality, leading to the recommendation from the Data Safety Monitoring Board (DSMB) to proceed to the next cohort [2][8] Company Commitment - The company emphasizes its commitment to addressing chronic back pain, a condition with limited effective treatment options, and believes CELZ-201-DDT could transform the standard of care for patients [4][5] - CELZ-201-DDT aims to leverage stem cell technology to address the root causes of pain and degenerative conditions, providing a novel, non-opioid therapeutic option [4][5] Study Design and Future Plans - The Phase 1/2 study is designed to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT, with plans to enroll 30 individuals suffering from chronic lower back pain [6][8] - Enrollment for the second cohort is expected in the first quarter of 2025, with comprehensive data from subsequent cohorts guiding future clinical and regulatory plans [8]
Creative Medical Technology Holdings Announces Positive Initial Safety, Tolerability, and Efficacy Data from First Cohort in Phase 1/2 Trial of CELZ-201-DDT for Chronic Back Pain