Aim: A 3-month pilot study to evaluate the safety of injecting a bone marrow-derived mesenchymal stem cell extracellular vesicle advanced investigational product (IP) into the lumbar facet joint space as a treatment for chronic low back pain. Methods: 20 healthy adults were treated with IP injections (0.5 ml/joint) and evaluated by three functional assessments 1, 3, 7, 14, 30, 60 and 90 days later. Results: No adverse effects or complications occurred across the 3-month follow-up. There were no reports of worsening pain. After 3 months group average scores improved significantly (p < 0.0001) in the Severity Index (65.04%), Interference Index (72.09%) and Oswestry Disability Index (58.43%) assessments. Conclusion: IP injections were safe and associated with significant functional improvements.
Keywords: MSC; exosomes; extracellular vesicle; lumbar facet joint pain; regenerative medicine.
What is this article about? Bone marrow mesenchymal stem cell derived extracellular vesicles (BM-MSC EV), a novel biologic therapeutic candidate, are a safe and promising therapeutic intervention for patients with lumbar facet joint pain, a malady that manifests as persistent low back pain (LBP). 20 adult subjects with lumbar facet joint pain received a single injection of BM-MSC EV investigational product in the lumbar facet joint space. What were the results? Follow-up was conducted through in-office and virtual visits that included outcome measures to determine the safety and efficacy of this therapy. By the 3-month end point, follow-up was successful, and no complications or adverse events were noted. Significant improvements in all three assessments of pain and disability occurred throughout the study. What do the results of the study mean? The results are promising and suggest that BM-MSC EV may represent a revolutionary treatment option with durable efficacy and minimal safety risks. Randomized, controlled clinical studies into the application of BM-MSC EV in lumbar facet joint pain should be pursued to confirm the potential benefits of this novel intervention.