TOPLINE:
Allogeneic bone marrow–derived mesenchymal stromal cells (BM-MSCs) are safe but do not show efficacy in treating intervertebral disc degeneration (IDD) in patients with chronic low back pain.
METHODOLOGY:
- The RESPINE trial assessed the efficacy and safety of a single intradiscal injection of allogeneic BM-MSCs in the treatment of chronic low back pain caused by single-level IDD.
- Overall, 114 patients (mean age, 40.9 years; 35% women) with IDD-associated chronic low back pain that was persistent for 3 months or more despite conventional medical therapy and without previous surgery, were recruited across four European countries from April 2018 to April 2021 and randomly assigned to receive either intradiscal injections of allogeneic BM-MSCs (n = 58) or sham injections (n = 56).
- The first co-primary endpoint was the rate of response to BM-MSC injections at 12 months after treatment, defined as improvement of at least 20% or 20 mm in the Visual Analog Scale for pain or improvement of at least 20% in the Oswestry Disability Index for functional status.
- The secondary co-primary endpoint was structural efficacy, based on disc fluid content measured by quantitative T2 MRI between baseline and month 12.
TAKEAWAY:
- At 12 months post-intervention, 74% of patients in the BM-MSC group were classified as responders compared with 68.8% in the placebo group. However, the difference between the groups was not statistically significant.
- The probability of being a responder was higher in the BM-MSC group than in the sham group; however, the findings did not reach statistical significance.
- The average change in disc fluid content, indicative of disc regeneration, from baseline to 12 months was 37.9% in the BM-MSC group and 41.7% in the placebo group, with no significant difference between the groups.
- The incidence of adverse events and serious adverse events was not significantly different between the treatment groups.
IN PRACTICE:
“BM-MSC represents a promising opportunity for the biological treatment of IDD, but only high-quality randomized controlled trials, comparing it to standard care, can determine whether it is a truly effective alternative to spine fusion or disc replacement,” the authors wrote.
SOURCE:
The study was led by Yves-Marie Pers, MD, PhD, Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France. It was published online on October 11, 2024, in Annals of the Rheumatic Diseases.
LIMITATIONS:
MRI results were collected from only 55 patients across both trial arms, which may have affected the statistical power of the findings. Although patients were monitored for up to 24 months, the long-term efficacy and safety of BM-MSC therapy for IDD may not have been fully captured. Selection bias could not be excluded because of the difficulty in accurately identifying patients with chronic low back pain caused by single-level IDD.
DISCLOSURES:
The study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. The authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.