Creative Medical Technology Holdings, Inc. announced the successful completion of an independent interim safety review by the Data Safety Monitoring Board (DSMB) for its ADAPT clinical trial. This trial is evaluating CELZ-201, a novel therapeutic for chronic lower back pain associated with degenerative disc disease. The DSMB reviewed safety data from the first five dosed patients.
The DSMB concluded that the trial may proceed as planned, underscoring the safety profile of CELZ-201. This positive review follows the completion of a rigorous 30-day dose-limiting toxicity (DLT) assessment per patient, which is an important milestone in the clinical development process. The validation of safety supports the advancement of this innovative therapy.
The ADAPT trial (CELZ-201-ADAPT-2023) is a double-blind, randomized, placebo-controlled, dose-escalation study. The positive safety review fuels confidence in the regenerative biologic approach for chronic lower back pain, a condition affecting 16 million patients in the United States with limited long-term solutions.
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