During treatment, a single dose of IDCT is injected into the painful disc percutaneously. Credit: DiscGenics / PRNewswire.

The US Food and Drug Administration (FDA) has granted approval to DiscGenics for a Phase III clinical trial of its allogeneic injectable disc progenitor cell therapy (IDCT or rebonuputemcel) to treat symptomatic lumbar degenerative disc disease (DDD).

The company had sought approval for the study’s clinical protocols and chemistry, manufacturing, and controls (CMC) clinical development plan.

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This Phase III clinical programme will consist of two concurrent studies: the pivotal study (DGX-A02 or PIVOT) and the confirmatory study (DGX-A03 or CONFIRM).

Both are double-blinded, randomised, sham-controlled, multicentre trials, enrolling subjects with single-level symptomatic lumbar intervertebral disc degeneration.

Success in this Phase III clinical programme could lead to a biologics licence application (BLA) with the FDA.

IDCT is currently under review under an investigational new drug (IND) allowance by the US regulator and is a standalone, single-injection biologic treatment.

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It is designed to arrest the progression of symptomatic lumbar disc degeneration and potentially regenerate the intervertebral discs.

The active ingredient in IDCT is a live, manufactured progenitor cell population derived from donated adult human intervertebral disc tissue.

These cells undergo enrichment and expansion into discogenic cells through a detailed manufacturing process, adhering to current good manufacturing practices (cGMP), which enhances proliferation and induces phenotypic changes in the cells.

The cells are then combined with a viscous sodium hyaluronate solution and excipients to create IDCT, the final drug product.

IDCT is cryopreserved and stored as individual doses ready for ‘off-the-shelf’ use, administered via percutaneous injection into the intervertebral disc in an outpatient setting.

DiscGenics CEO and board chairman Flagg Flanagan said: “From the early founding of this cell technology by the late Dr Valery Kukekov to the successful first-in-human clinical evaluation of IDCT, we have become more confident not only around the safety of the cell but also its regenerative potential.

“Our team has been passionately persistent in achieving this important regulatory milestone, which allows us to continue fulfilling our responsibility as stewards of this technology.”

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