Creative Medical Technology Holdings, Inc. 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. 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.

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.