Creative Medical Technology Holdings (NASDAQ: CELZ) Granted FDA Clearance To Begin Phase 1/2 Clinical Trial Of AlloStem™ For Addressing Chronic Lower Back Pain

Creative Medical Technology Holdings, Inc. CELZ, a biotechnology company has received clearance from the FDA to conduct a phase 1/2 clinical trial using their innovative 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.

What sets AlloStem™ apart is its unique immunomodulatory formula derived from allogeneic perinatal cells. These cells have shown promise in tissue repair and can influence cytokine profiles, which play a crucial role in the body's immune response and tissue healing processes.

Chronic back pain affects around 80% of adults. This long-lasting pain can greatly affect a person's quality of life, causing limited mobility, challenges in performing daily tasks and an increased likelihood of depression and anxiety. The economic consequences of chronic back pain are also substantial, with billions of dollars spent each year on medical treatments, reduced productivity, and disability payments. According to a report by the National Institutes of Health, approximately $200 billion is spent annually on managing back pain.

"The FDA's clearance and IRB approval allowing us to pursue this clinical trial is another 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."

CELZ-201-DDT is unique because it uses a customized immunomodulatory formula made of perinatal cells derived from donors. Initial studies have shown that this formula has the potential for tissue repair and to change cytokine profiles – paving the way for further research in regenerative medicine in areas of immunotherapy, endocrinology, gynecology, urology and orthopedics.

"Chronic lower back pain is an increasing cause of disability globally," shared 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."

The trial seeks to enroll approximately 30 individuals, and the company is hopeful that the study will provide the necessary information to move toward a new, innovative treatment for chronic lower back pain in the future. With the necessary endorsement from the FDA and an ongoing clinical trial, Creative Medical Technology’s recent developments potentially set the stage for innovative treatment options that could significantly improve the lives of patients grappling with chronic pain and other diseases. 

Featured photo by Otto Norin on Unsplash.

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