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Creative Medical Gets IRB Approval For StemSpine Trial Using AlloStem Cell Therapy
(RTTNews) - Biotechnology company Creative Medical Technology Holdings, Inc. (CELZ) announced Tuesday 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.
The 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.
FDA-regulated IRB's 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.
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.
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