Creative Medical Technology has received clearance from the Institutional Review Board (IRB) to initiate a Phase I/II clinical trial of the StemSpine procedure using AlloStem (CELZ-201-DDT) cell therapy to treat chronic lower back pain.
The FDA-approved, placebo-controlled, double-blind, randomised study is designed to assess the tolerability, efficacy and safety of CELZ-201-DDT.
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It intends to enrol 30 patients aged 18 to 80 with chronic lower back pain caused by degenerative disc disease.
Each cohort will include ten subjects who will receive six paraspinal intramuscular injections of low, medium, or high doses of CELZ-201-DDT or a placebo into the lumbar musculature under direct ultrasound guidance.
Evaluating the safety of CELZ-201-DDT in subjects experiencing chronic lower back pain at low, medium, or high doses for six months is the primary outcome measure of the study.
Creative Medical Technology CEO Timothy Warbington said: “Studies show that 8% of all adults in the US, approximately 16 million people, experience chronic lower back pain.
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By GlobalData“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.”
AlloStem repairs and improves the blood supply around the disc and lower back area without exposing the patient to radiation, as compared to other cell-based procedures.
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
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