Creative Medical Technology announces FDA clearance to begin Phase 1/2 trial

Creative Medical Technology Holdings reports the company has received clearance from the FDA to conduct a phase 1/2 clinical trial using their StemSpine treatment known as AlloStem “This study aims to determine the safety, efficacy and tolerability of CELZ-201-DDT, a proprietary, ready-to-use cell line developed by the company. The trial will focus on individuals with chronic lower back pain, providing them with an AlloStem injection surrounding the affected disc(s) using an ultrasound-guided, non-surgical procedure that is radiation-free. This delivery method aims to repair and remodel the surrounding tissue, improving the blood supply to the affected area and potentially alleviating the chronic pain symptoms experienced by the patient,” the company stated. Timothy Warbington, CEO of Creative Medical Technology, said: “An estimated 20% of Americans suffer from chronic lower back pain, with many of these individuals relying on opioids as the standard of care for relief. With an opioid crisis in the United States, we believe that CELZ-201-DDT is potentially a more effective, sustainable, and safer non-surgical pain management option compared to opioids, and we look forward to advancing these studies.”