Discogenic Cells

dis·co·gen·ic cells [disk-oh-jen-ik selz]

noun.

1. A manufactured, live progenitor cell population derived from donated adult human intervertebral disc tissue.

Engineering Discogenic Cells

DiscGenics uses its patented allogeneic cell culture manufacturing technology to isolate and differentiate the native nucleus pulpous cells within donated adult human intervertebral disc tissue into a progenitor state. These proprietary allogeneic disc progenitor cells, known as Discogenic Cells, are then enriched and expanded for therapeutic application through a multistep process in a highly controlled environment under cGMP. To create IDCT (rebonuputemcel), the Discogenic Cells are then combined with a delivery vehicle and cryoprotectants, filled into vials, labeled, and cryopreserved for off-the-shelf use.

Discogenic Cells are reproducibly manufactured in a cGMP environment and are subjected to extensive testing prior to use, including identity, purity, potency and safety evaluations.

To date, comparability has been demonstrated on over a dozen cell lines, with current production capabilities allowing for the manufacture of thousands of doses from a single donor. 

Dual Proposed Modes of Action

Discogenic Cells offer a novel approach to treating diseases of the disc. These specialized cells are hypothesized to not only possess the key regenerative and anti-inflammatory properties found in mesenchymal stem cells (MSCs), but also to produce important molecules that provide support and structure to the disc.

Importantly, prior to the culture process, Discogenic Cells begin as disc cells and already know how to behave in the unique and harsh environment of a degenerated disc. Other approaches that use unspecialized cells from sources like bone marrow or adipose fat tissue must first adapt to the disc environment before even attempting to affect it.

IDCT for Lumbar Disc Degeneration

The first product candidate to utilize the Discogenic Cell platform is a novel allogeneic injectable, disc-derived progenitor cell therapy, known as IDCT (rebonuputemcel), intended to treat early to moderate, symptomatic lumbar degenerative disc disease.

IDCT is a standalone, single-injection biologic treatment designed to halt progression of symptomatic lumbar disc degeneration and regenerate the disc from the inside out.

During treatment, a single dose of IDCT is injected into the painful disc percutaneously (non-surgically). 

IDCT has been granted regenerative medicine advanced therapy (RMAT) and Fast Track designations by the U.S. Food and Drug Administration.

IDCT is being evaluated in a Phase III clinical program agreed upon with the FDA. The progam will consist of two identical studies running in parallel: the pivotal study (DGX-A02 or PIVOT) and the confirmatory study (DGX-A03 or CONFIRM). Both studies are randomized, double-blinded, Sham-controlled, multicenter studies in subjects with single-level symptomatic lumbar intervertebral disc degeneration.

Disclaimer: IDCT (rebonuputemcel) is an investigational product that is under development by DiscGenics and has not been approved by the FDA or any other regulatory agency for human use.

Preclinical Studies

Animal studies across various species have consistently demonstrated that Discogenic Cells, the active ingredient in IDCT (rebonuputemcel) are safe, shown to be bioactive upon injection, and are well retained within the treated disc. Importantly, Discogenic Cells are absent of surface markers (CD40, CD80, CD86) as well as HLA expression, which are required for effector T cell induction; thereby minimizing the risk of immune rejection or immunogenicity.  

Product Pipeline

Intellectual Property

DiscGenics’ cell isolation and manufacturing process is protected globally by over 40 issued patents and 30 additional patents pending, and is trade secret protected.

Scientific Publications

Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration—Results of an FDA-Approved Biologic Therapy Randomized Clinical Trial

June 2024