Creative Medical Technology Holdings Receives FDA Clearance to Initiate a Phase 1/2 Clinical Trial of StemSpine using AlloStem

Creative Medical Technology Holdings, Inc. (CELZ), a biotechnology company focused on a regenerative approach to immunotherapy, endocrinology, urology, gynecology, and orthopedics, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company to proceed with a Phase 1/2 clinical trial of StemSpine^® using AlloStem^™ ("CELZ-201-DDT").

The study is designed to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT. The study will enroll 30 individuals suffering from chronic lower back pain. CELZ-201-DDT is a patented procedure that utilizes an "off the shelf, ready-to-use" universal and proprietary allogenic (donor) cell line developed by the Company and trademarked as AlloStem^™. Using an ultrasound guided, non-surgical procedure AlloStem^™ is injected in areas surrounding the diseased disc(s), thereby potentially repairing, remodeling, and improving the blood supply around the disc and lower back area, without exposing the patient to radiation as with other cell-based procedures. CELZ-201-DDT distinguishes itself by using a unique immunomodulatory formula derived from allogeneic perinatal cells, which in preliminary studies have shown potential for tissue repair and changing cytokine profiles.

"The FDA's clearance allowing us to pursue this clinical trial is a milestone event for Creative Medical Technology and a validation of our commitment to developing and advancing novel regenerative therapeutics that can improve patient lives," said Timothy Warbington, CEO of Creative Medical Technology. "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."

"Chronic lower back pain is an increasing cause of disability globally," noted Courtney Bartlett, Director of Clinical Development. "This clinical trial sets the foundation to potentially help patients with a safer alternative therapy for chronic lower back pain as the procedure can be performed in the outpatient setting under direct ultrasound guidance, without any radiation exposure."