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# FDA OKs Phase 3 Trial of Lumbar Cell Therapy
- URL: https://www.fdaweb.com/fda-oks-phase-3-trial-of-lumbar-cell-therapy/
- Published: 2024-07-16T12:00:00.000Z
- Updated: 2026-09-14T14:35:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157363

FDA has given DiscGenics the green light for a Phase 3 clinical trial after agreeing to the clinical protocols and chemistry, manufacturing, and controls clinical development plan for its allogeneic injectable disc progenitor cell therapy (IDCT or rebonuputemcel) for painful lumbar degenerative disc disease. “There are very few credible treatments on the market for mechanical back pain, and we believe early clinical evidence suggests DiscGenics’ cell therapy has the potential to shift the paradigm of care from ablative/destructive procedures or fusion surgery to a revolutionary regenerative and minimally invasive treatment for patients suffering from painful degenerative disc disease,” the company says in a release.

The Phase 3 clinical program will consist of two identical studies running in parallel — the pivotal study (DGX-A02 or PIVOT) and the confirmatory study (DGX-A03 or CONFIRM), according to DiscGenics. “Both studies are randomized, double-blinded, sham-controlled, multicenter studies in subjects with single-level symptomatic lumbar intervertebral disc degeneration,” it says.

IDCT is described as a standalone, single-injection biologic treatment designed to halt progression of symptomatic lumbar disc degeneration and regenerate the disc from the inside out. It comprises a live, manufactured progenitor cell population derived from donated adult human intervertebral disc tissue, the company says. “These cells are enriched and expanded into Discogenic Cells through a multistep manufacturing process in a highly controlled environment under current good manufacturing practices (cGMP) that results in significant proliferation and phenotypic changes to the cells,” it adds.