Creative Medical Technology (CELZ) said Thursday the US Food and Drug Administration has allowed an increased dosing plan in its ongoing phase 1/2 trial of its cell therapy targeting chronic lower back pain caused by degenerative disc disease.
The decision follows interim blinded results showing significant pain reduction and mobility improvements with the use of CELZ-201-DDT among trial participants, the company said.
The FDA authorization allows the trial to move forward with dose escalation, which has already been approved by the study's safety and ethics boards.
Creative Medical said no serious side effects or dose-limiting toxicities have been reported halfway through the study.
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