DiscGenics’s IDCT cell therapy has passed the initial planned safety review of its Phase I/II trial evaluating the allogeneic, injectable disc cell therapy in patients with mild to moderate degenerative disc disease (DDD).
In this first planned safety review, an independent data safety monitoring committee (DSMC) reviewed the first six subjects, each of whom was randomly assigned to receive an intradiscal injection of the low dose IDCT study treatment, vehicle or placebo.
The DSMC reported there were no safety issues and recommended that the trial continue with no changes to the protocol.
Flagg Flanagan, Chief Executive Officer and Chairman of the Board of Directors for DiscGenics said that this is the first time IDCT has been administered to patients, and we are thrilled that there were no issues reported in this initial safety review. “As an organization, we are committed to protecting patient safety and are very pleased that the safety profile we witnessed in our preclinical experience with IDCT is being reflected now that the therapy is being used in human patients,” Flanagan said in the statement.