Low-dose Mesenchymal Stem Cell Therapy for Discogenic Pain: Safety and Efficacy Results From a 1-year Feasibility Study

Abstract

Aim: To evaluate safety and efficacy of low dose autologous adipose-derived mesenchymal stem cells (ADMSCs) for treatment of disc degeneration resulting in low back pain (LBP). Methods: Nine participants with chronic LBP originating from single-level lumbar disc disease underwent intradiscal injection of 10 million ADMSCs with optional repetition after 6 months. Results: No unexpected or serious adverse events were recorded. Seven (78%) of participants reported reductions in pain 12 months after treatment. Five (56%) reported increased work capacity. Three (33%) reduced analgesic medication. Improvements in EQ-5D and Oswestry disability index results were observed. MRI demonstrated no further disc degeneration and improvements to annular fissures and disc protrusions. Conclusion: This study provides initial evidence of safety and efficacy of ADMSCs for discogenic LBP.

Plain Language Summary

This feasibility study sought to evaluate the safety and efficacy of low dose autologous adipose-derived mesenchymal stem cells (ADMSCs) for treatment of disc degeneration resulting in low back pain (LBP) in 9 participants. No unexpected or serious adverse events were recorded. Seven (78%) of participants reported reductions in pain 12 months after treatment. Five (56%) reported increased work capacity. Three reduced analgesic medication. Quality of life improvements were also observed. Conclusion: This study provides initial evidence of safety and efficacy of ADMSCs for discogenic LBP.

Keywords:

• chronic pain
• disc degeneration
• discogenic low back pain
• feasibility study
• mesenchymal stem cells

Author contributions

D Bates, D Vivian and J Freitag had clinical responsibility of participants, including performing procedures, and were involved with the initial design of the study. J Wickham, B Mitchell, P Verrills and R Boyd were involved with the initial design of the study. K Shah managed the laboratory component of the study. D Federman reviewed, analyzed and interpreted the MRIs. A Barnard was involved in the initial study design and protocol development. L O'Connor was involved in protocol development and drafting of the manuscript. J Young performed data analysis and interpretation of results and drafted the manuscript. All authors reviewed the manuscript.

Financial & competing interests disclosure

This research was jointly funded and co-sponsored by Monash Clinical Research, Metro Pain Group, Melbourne Stem Cell Centre and Magellan Stem Cells. The following authors are affiliated with the following companies who perform stem cell treatments commercially: J Freitag, D Bates, B Mitchell, P Verrills and D Vivian: Melbourne Stem Cell Centre; and/or J Freitag, D Bates, B Mitchell, P Verrills, D Vivian and K Shah: Magellan Stem Cells. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

This study has been performed in accordance with the principles outlined in the Declaration of Helsinki for all human experimental investigations and follows all ICH-GCP principles. The study was approved by the Human Research and Ethics Committee (H17027) of Charles Sturt University and registered on the Australian and New Zealand Clinical Trials Registry (trial no. 12617000636358). All participants signed informed consent prior to commencement.