Perspective on Intradiscal Therapies for Lumbar Discogenic Pain: State of the Science, Knowledge Gaps, and Imperatives for Clinical Adoption

Abstract

Specific clinical diagnostic criteria have established a consensus for defining patients with lumbar discogenic pain. However, if conservative medical management fails, these patients have few treatment options short of surgery involving discectomy often coupled with fusion or arthroplasty. There is a rapidly-emerging research effort to fill this treatment gap with intradiscal therapies that can be delivered minimally-invasively via fluoroscopically guided injection without altering the normal anatomy of the affected vertebral motion segment. Viable candidate products to date have included mesenchymal stromal cells, platelet-rich plasma, nucleus pulposus structural allograft, and other cell-based compositions. The objective of these products is to repair, supplement, and restore the damaged intervertebral disc as well as retard further degeneration. In doing so, the intervention is meant to eliminate the source of discogenic pain and avoid surgery. Methodologically rigorous studies are rare, however, and based on the best clinical evidence, the safety as well as the magnitude and duration of clinical efficacy remain difficult to estimate. Further, we summarize the US Food and Drug Administration's (FDA) guidance regarding the interpretation of the minimal manipulation and homologous use criteria, which is central to designating these products as a tissue or as a drug/device/biologic. We also provide perspectives on the core evidence and knowledge gaps associated with intradiscal therapies, propose imperatives for evaluating effectiveness of these treatments and highlight several new technologies on the horizon.

A Self-Polymerizing Mesh of Nano-Tethers for the Mechanical Constraint of Degraded Intervertebral Discs—A Review of 25 Years of Pre-Clinical and Early Clinical Research

“…Of high importance with regard to selecting appropriate candidates for this intervention, knowledge of the pathological processes of symptomatic internal disc disruption and the capability to identify patients with earlier-stage lumbar discogenic pain [ 64 ] have advanced considerably during the course of the investigations summarized here. These existing and emerging assessments, outside of the scope of this present review, involve functional MRI, MR spectroscopy and other advanced imaging techniques [ 64 , 65 , 66 ], the radiographic assessment of sagittal translation, rotations, and instability and associated clinical tests [ 67 , 68 , 69 ], and provocation or anesthetic discography combined with computed tomography (CT discogram) [ 64 , 66 ].…”