It has been announced that IDCT (DiscGenics) 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.
The IDCT trial is a prospective, randomised, double-blinded, vehicle- and placebo-controlled, multicentre clinical study to evaluate the safety and preliminary efficacy of IDCT in subjects with single-level, symptomatic lumbar intervertebral disc degeneration. The trial is underway in more than 10 centres across the USA and will enrol 60 subjects.
Those subjects who meet all eligibility criteria are being randomised to one of four treatment cohorts: low dose IDCT (n=20), high dose IDCT (n=20), vehicle (n=10) and placebo (n=10). Each subject receives a single intradiscal injection of his or her assigned treatment into the target symptomatic lumbar intervertebral disc. Following treatment, subjects will be observed and evaluated for a period of one year, with a one-year extension period.
Through this study, IDCT is being evaluated under an investigational new drug (IND) allowance by the US Food and Drug Administration (FDA) and will be regulated as a drug-biologic through a therapeutics biologics application (BLA).
