Creative Medical Technology Holdings, Inc. announced that the U.S. Food and Drug Administration has cleared the Company to proceed with a Phase 1/2 clinical trial of StemSpine® using AlloStem. The study is designed to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT. The study will enroll 30 individuals suffering from chronic lower back pain.

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?. Using an ultrasound guided, non-surgical procedure AlloStem? is injected in areas surrounding the diseased disc(s), thereby potentially repairing, remodeling, and improving the blood supply around the disc and lower back area, without exposing the patient to radiation as with other cell-based procedures.

CELZ-201-DDT distinguishes itself by using a unique immunomodulatory formula derived from allogeneic perinatal cells, which in preliminary studies have shown potential for tissue repair and changing cytokine profiles.