IDCT (DiscGenics) has passed the initial safety review of its double blinded clinical study evaluating the allogenic, injectable disc cell therapy in Japanese patients with mild to moderate degenerative disc disease (DDD), DiscGenics has announced.
IDCT is a homologous, allogeneic, injectable cell therapy that utilises biomedically engineered progenitor cells, known as Discogenic Cells, that have been derived from intervertebral disc tissue to offer a non-surgical, potentially regenerative solution for the treatment of mild to moderate DDD—a major cause of chronic low back pain.
The prospective, randomised, double-blinded, sham-controlled study commenced in 2019. It is being conducted at six universities across Japan to evaluate the safety and preliminary efficacy of IDCT at two dosage levels in Japanese patients with single-level, symptomatic lumbar DDD.
In this first planned safety review, an independent data safety monitoring committee (DSMC) reviewed unblinded data from the first five subjects, each of whom was randomly assigned to receive an intradiscal injection of the low dose IDCT study treatment, high dose IDCT study treatment or sham control.
The DSMC reported there were no safety issues and recommended that the study continue with no changes to the protocol.
“We are delighted to have cleared this initial planned safety review and to be advancing to our next phase of patient enrolment, as we believe IDCT has the potential to be a revolutionary treatment option for those suffering from chronic low back pain,” said Flagg Flanagan, chief executive officer and chairman of the board of directors for DiscGenics. “This is a blinded, study where neither the treating clinicians nor the patients know what treatment is being administered. As a result, performance of periodic safety checks by an unblinded and independent body is essential to ensuring the ongoing safety of IDCT in a clinical setting.”
DiscGenics is conducting an ongoing phase I/II prospective, randomised, double-blinded, vehicle- and placebo-controlled, multicentre clinical trial of IDCT in the US. 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). The US study has passed all three planned mid-trial safety reviews and has commenced the final enrolment stage.