Oral Presentation 51st International Society for the Study of the Lumbar Spine Annual Meeting 2025

INTRODUCTION

Low back pain (LBP) is the leading cause of disability worldwide, with intervertebral disc degeneration (IDD) being a major contributor. While traditional treatments have focused on symptom management, mesenchymal stromal cell (MSC)-based therapies have emerged as promising strategies for addressing the underlying pathology. Previous studies have shown clinically meaningful improvements in patients with chronic discogenic LBP following MSC injection. However, trial results have often been hampered by small sample sizes and experimental design limitations, preventing a full understanding of the therapeutic effect of intradiscal cell therapy. This randomized controlled trial (RCT) aimed to evaluate the efficacy and safety of autologous bone marrow-derived mesenchymal stromal cells (BM-MSCs) for treating chronic LBP due to multilevel IDD.

METHODS

This single-centre, prospective, randomized, double-blind controlled phase IIB trial included workers aged 18-65 with chronic LBP (VAS ≥4/10) due to moderate to severe IDD (Pfirrmann score 3-5, Griffith score 4-8) involving up to 4 lumbar levels and unresponsive to conservative treatments for at least 6 months. Participants were randomized to receive either an intradiscal injection of autologous BM-MSCs (15x10⁶ cells per disc) or a sham procedure. BM-MSCs were expanded for 3 weeks in good manufacturing practice (GMP) conditions and implanted within 24 hours after release. Outcomes were assessed at baseline, 3, 6, and 12 months using the Visual Analogue Scale (VAS) for pain, Oswestry Disability Index (ODI), Short Form Health Survey 36 (SF-36), and Work Ability Index (WAI). Safety and tolerability were also monitored. Pairwise comparisons between preoperative and postoperative timepoints were conducted with paired sample t-tests. Repeated-measures ANOVA was performed to analyze the differences between preoperative and postoperative 12-month timepoints

RESULTS

Forty-three patients were included in the analysis (Fig. 1). The BM-MSC group showed statistically significant improvements in all clinical outcomes compared to baseline at 12 months. LBP intensity (VAS) significantly decreased in the treatment group, compared to both the baseline (p=0.003) and the sham group (p=0.033). Quality of life (SF-36) and work ability (WAI) significantly improved in the treatment group compared to the baseline (p=0.016 and p=0.050, respectively), although no significant differences emerged between groups. Disability (ODI) significantly improved in both treatment (p=0.022) and control group (p=0.022) compared to baseline. No serious adverse events were reported, with only 9 minor adverse events recorded.

DISCUSSION

This study represents the first RCT evaluating the efficacy of intradiscal autologous BM-MSC for chronic LBP due to multilevel lumbar IDD. The treatment group demonstrated a consistent trend of improvement across all outcomes, while the control group showed a tendency towards deterioration at 12 months. The initial improvement observed in the control group may be attributed to a placebo effect, highlighting the importance of considering contextual factors in pain management studies. These results suggest that autologous BM-MSC injections are a promising treatment for LBP in adult patients with multilevel IDD. Future research should focus on larger patient cohorts, longer follow-up periods, and better patient selection to further validate these findings.

Fig. 1. Flowchart of the clinical trial.