Creative Medical Technology Holdings Announces IRB Approval for FDA Cleared Phase 1/2 Clinical Trial of StemSpine® using AlloStem™ ("CELZ-201-DDT") Novel Cell Therapy to Treat Chronic Lower Back Pain

About this update from Creative Medical Technology Holdings, Inc.

[{"type":"text","content":"Company reaches next clinical trial milestone for the intramuscular treatment of Chronic Lower Back Pain with the first novel allogenic cellular therapy in the United States\nPHOENIX, Oct. 10, 2023 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. (\"Creative Medical Technology\" or the \"Company\") (NASDAQ: CELZ), a biotechnology company focused on a regenerative approach to immunotherapy, endocrinology, urology, gynecology, and orthopedics, today announced that it has received Institutional Review Board (\"IRB\") approval to proceed with its clinical trial for the treatment of chronic lower back pain with its StemSpine® procedure using AlloStem™ (\"CELZ-201-DDT\") cell therapy.\n\n \n \n \n \n \n \n\n \nThe receipt of IRB approval is a necessary step that will allow Creative Medical Technology to move forward with recruitment of its recently FDA approved Phase 1 /2 randomized, double blind, placebo controlled clinical trial to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT. The study will enroll 30 individuals suffering from chronic lower back pain caused by Degenerative Disc Disease.\nAn IRB is an FDA-registered consortium that has been formally designated to review and monitor biomedical research involving human subjects. IRB approval is a critical and necessary prerequisite to commencing human clinical trials and serves an important role in the protection of the rights and welfare of human research subjects.\n\"We are pleased to announce the expeditious receipt of this vital next step in commencing the clinical trial for CELZ-201-DDT,\" said Timothy Warbington, CEO of Creative Medical Technology. \"Studies show that 8% of all adults in the United States, approximately 16 million people, experience chronic lower back pain. The economic impact is also significant, as a report from the National Library of Medicine estimates that $200 billion is spent annually on the management of back pain. In addition to limiting their daily activities and negatively impacting their quality of life, many of those suffering rely on opioids as the standard of care which carry their own side effects, not the least of which is addiction. We are hopeful that the outcome of this clinical trial will validate the efficacy, safety, and endurance of CELZ-201-DDT as a non-surgical treatment option for chronic lower back pain.\"...

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