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.

Keywords:

• degenerative
• disc
• intradiscal
• autologous
• allogeneic
• injection
• regenerative
• discogenic
• pain

Data Sharing Statement

Requests for data sharing can be made by contacting the corresponding author. Individual participant data that underlie the results reported in this article will be made available (after deidentification) from 9 to 36 months after article publication. Data sharing will be limited to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Acknowledgments

We appreciate the scientific review of the text by Timothy Ganey, Ph.D. Financial support for this work was provided by Vivex Biologics (Miami, FL, USA).

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

JT reports grants and/or personal fees from Vivex, Mainstay, Abbott, Saluda, and Curonix, during the conduct of the study. JB is an independent advisor to Vivex Biologics and was remunerated for assistance in manuscript development. DPB is a consultant to Mesoblast, DiscGenics, Spine Biorestorative, Orthoson, and Vivex, has received research funding from Mesoblast, Discgenics, Spine Biorestorative, and Vivex, and is on the scientific advisory board of Orthoson, Vivex, and Mesoblast. The authors report no other conflicts of interest in this work.