Perspectives on the Treatment of Lumbar Disc Degeneration: The Value Proposition for a Cell-Based Therapy, Immunomodulatory Properties of Discogenic Cells and the Associated Clinical Evaluation Strategy

Abstract

Low back pain (LBP) is a serious medical condition that affects a large percentage of the population worldwide. One cause of LBP is disc degeneration (DD), which is characterized by progressive breakdown of the disc and an inflamed disc environment. Current treatment options for patients with symptomatic DD are limited and are often unsuccessful, so many patients turn to prescription opioids for pain management in a time when opioid usage, addiction, and drug-related deaths are at an all-time high. In this paper, we discuss the etiology of lumbar DD and currently available treatments, as well as the potential for cell therapy to offer a biologic, non-opioid alternative to patients suffering from the condition. Finally, we present an overview of an investigational cell therapy called IDCT (Injectable Discogenic Cell Therapy), which is currently under evaluation in multiple double-blind clinical trials overseen by major regulatory agencies. The active ingredient in IDCT is a novel allogeneic cell population known as Discogenic Cells. These cells, which are derived from intervertebral disc tissue, have been shown to possess both regenerative and immunomodulatory properties. Cell therapies have unique properties that may ultimately lead to decreased pain and improved function, as well as curb the numbers of patients pursuing opioids. Their efficacy is best assessed in rigorous double-blinded and placebo-controlled clinical studies.

Transition from static culture to stirred tank bioreactor for the allogeneic production of therapeutic discogenic cell spheres

“…While we used aggrecan production to guide our CFD models, other parameters could be used in the future as well. We have demonstrated that other molecules, such as collagen and anti-inflammatory molecules are also relevant to the mode of action of Discogenic Cells in treating lumbar disc degeneration [ 12 , 32 ]. Further work is needed to evaluate these potency measures in the context of transitioning to a STR and scaling into larger volumes.…”

A Risk Assessment Study of SARS-CoV-2 Propagation in the Manufacturing of Cellular Products

“…Discogenic cells are progenitor cells originating from adult human intervertebral disc tissue, specifically from the nucleus pulposus tissue, and have a notochordal origin [ 57 ]. These cells exhibit a multipotency for mesenchymal lineage differentiation [ 58 ] which could suggest a similar phenotype to MSCs, namely no ACE2 and TMPRSS2 expression and no susceptibility to coronavirus infection [ 50 , 51 ].…”

Controversies in spine research: Organ culture versus in vivo models for studies of the intervertebral disc

“…These treatments may involve medications such as nonsteroidal anti‐inflammatory drugs (NSAIDs), which can address acute symptoms but carry the risk of increased internal bleeding during long‐term use 16 . For more severe symptoms, opioid‐based medications may be prescribed, 17 but they pose a serious risk of addiction, exacerbating the opioid epidemic and associated morbidities 18–21 . Where conservative treatments do not appear to modify disease progression, surgical interventions such as spinal fusion or total disc arthroplasty may be employed, but these fail to preserve disc structure or mechanical function long‐term and may result in progression of IVDD in adjacent levels 15 .…”

“…16 For more severe symptoms, opioid‐based medications may be prescribed, 17 but they pose a serious risk of addiction, exacerbating the opioid epidemic and associated morbidities. 18 , 19 , 20 , 21 Where conservative treatments do not appear to modify disease progression, surgical interventions such as spinal fusion or total disc arthroplasty may be employed, but these fail to preserve disc structure or mechanical function long‐term and may result in progression of IVDD in adjacent levels. 15 Therefore, there is a significant clinical need for improved treatment options for patients suffering from IVDD and LBP that directly target the underlying causes.…”