DiscGenics has received the go-ahead from an independent data safety monitoring committee (DSMC) to enroll the final 24 patients in its first-in-human U.S. clinical study of IDCT, an allogeneic, injectable disc cell therapy for mild to moderate degenerative disc disease (DDD).
The DSMC completed a third and final planned mid-trial safety review following treatment of the first six subjects in the high dose study cohort, each of whom was treated based on random assignment into one of three arms: high dose IDCT study treatment, vehicle or placebo.
The DSMC reported there were no safety issues and recommended that the study proceed with completion of patient enrollment with no changes to the protocol.
This news closely follows a recent company announcement that the second planned safety review of the first 30-subject low dose study cohort revealed no safety issues.
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