Wharton's Jelly Mesenchymal Stem Cell-Derived Exosomes as an Adjunctive and Alternative Therapeutic Strategy in Spinal Disc Repair, Post-Surgical Recovery, and as a Replacement for FDA-Unindicated Epidural Corticosteroid Injections

Background

Epidural corticosteroid injections (ECIs), delivered via Tuohy (Touhy) needles, constitute one of the most frequently performed interventional pain procedures in the United States, despite the fact that corticosteroids have never received FDA approval for epidural administration. In April 2014, the FDA issued a Drug Safety Communication requiring manufacturers to add label language acknowledging that "the safety and effectiveness of epidural administration of corticosteroids have not been established" and that "serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids." Concurrently, the Discseel® Procedure, a biologic disc repair technique employing FDA-approved fibrin sealant, has demonstrated sustained efficacy in patients with annular tears and chronic discogenic pain.

Objective

This paper reviews the existing published literature on Wharton's Jelly mesenchymal stem cell-derived exosomes (WJ-MSC-EVs) and proposes their application as: (1) adjuncts to the Discseel® Procedure to amplify disc regeneration; (2) adjuncts to traditional spinal surgery to manage post-operative inflammation without FDA-unindicated agents; and (3) biologically superior and safer alternatives to epidural corticosteroid injections.