Discogenic Cell

dis·co·gen·ic cell [disk-oh-jen-ik sel]

noun.

1. A highly specialized therapeutic progenitor cell that is engineered to uniquely address the complex environment of the degenerated disc.

Engineering Discogenic Cells

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DiscGenics uses its patented allogeneic cell culture manufacturing technology to isolate cells from donated adult human intervertebral disc tissue and drive them back to a progenitor state. The partially differentiated stem cells are then expanded for therapeutic application, combined with a delivery vehicle and cryopreserved for off-the-shelf use.

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

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. 

 

Hypothesized Therapeutic Advantage

The degenerated disc is a unique and harsh environment. 

What sets Discogenic Cells apart from other cell-based approaches? 

Discogenic Cells begin as disc cells and already know how to behave in a disc environment. 

They are hypothesized to not only possess the key regenerative and anti-inflammatory properties found in mesenchymal stem cells (MSCs), but also produce important molecules that provide support and structure to the 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 Degenerative Disc Disease

The first product candidate to utilize the Discogenic Cell platform is IDCT.

IDCT is an allogeneic (donor-derived), non-invasive cell therapy that is being evaluated in a Phase I/II clinical trial for the treatment of patients with mild to moderate lumbar DDD.

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

Based on preclinical experience with IDCT, we hypothesize that the result will be reduced pain and disability caused by inflammation within the diseased disc. 

Disclaimer: IDCT 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 IDCT is safe, shown to be bioactive upon implantation, and is well retained within the treated disc.

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No IDCT-related safety concerns reported

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Significant improvement of disc height observed

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Normalization of disc architecture detected

Product Pipeline

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Intellectual Property

DiscGenics’ cell isolation and manufacturing process is protected globally by 24 issued patents and 15 additional patents pending, and is trade secret protected.

Scientific Publications

 

Evaluation of Intervertebral Disc-Derived Progenitor Cells (Discogenic Cells) Implanted into Subcutaneous Pouches of Athymic Mice

March 2018

Presented at the Orthopaedic Research Society (ORS) 2018 Annual Meeting.

DiscGenics ORS 2018 Athymic Mouse Model
 

Safety and Bioactivity of Disc-Derived Progenitor Cells to Treat Degenerative Disc Disease in a Rabbit Disc Model (GLP Study)

March 2018

Presented at the Orthopaedic Research Society (ORS) 2018 Annual Meeting.

DiscGenics ORS 2018 Rabbit Model
 

Assessment of Activity and Cell Persistence of a Novel Cell Therapy for the Treatment of Degenerative Disc Disease in a Gottingen Minipig Model: Xenogenic versus Allogeneic Considerations

March 2016

Presented at the Orthopaedic Research Society (ORS) 2016 Annual Meeting.

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The Impact of Cryopreservation on In Vitro and In Vivo Potency and Safety of a Novel Cell Therapy in a Rabbit Model of Degenerative Disc Disease

March 2016

Presented at the Orthopaedic Research Society (ORS) 2016 Annual Meeting.

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Characterization of a Novel Progenitor Cell with Therapeutic Potential Derived from Adult Human Intervertebral Disc Tissue

June 2016

Presented at the International Society for Stem Cell Research (ISSCR) 2016 Annual Meeting.

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Comparative Viability, Potency and In vivo Efficacy of a Fresh or Cryopreserved Cell Therapy for the Treatment of Degenerative Disc Disease

May 2015

Presented at the American Society of Gene & Cell Therapy (ASGCT) 2015 Annual Meeting. 

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The Effect of Dosing and Cryopreservation on Efficacy and Safety of a Novel Cell Therapy for Degenerative Disc Disease Using a Porcine Model: Sub-Acute and Chronic Time points 

March 2015

Presented at the Orthopaedic Research Society (ORS) 2015 Annual Meeting.

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