OBJECTIVES: To assess the efficacy of a single intradiscal injection of allogeneic bone marrow mesenchymal stromal cells (BM-MSCs) versus a sham placebo in patients with chronic low back pain (LBP).
METHODS: Participants were randomised in a prospective, double-blind, controlled study to receive either sham injection or intradiscal injection of 20 million allogeneic BM-MSC, between April 2018 and December 2022. The first co-primary endpoint was the rate of responders defined by improvement of the Visual Analogue Scale (VAS) for pain of at least 20% and 20 mm, or improvement of the Oswestry Disability Index (ODI) of 20% between baseline and month 12. The secondary structural co-primary endpoint was assessed by the disc fluid content measured by quantitative MRI T2, between baseline and month 12. Secondary endpoints included pain VAS, ODI, the Short Form (SF)-36 and the minimal clinically important difference in all timepoints (1, 3, 6, 12 and 24 months). We determined the immune response associated with allogeneic cell injection between baseline and 6 months. Serious adverse events (SAEs) were recorded.
RESULTS: 114 patients were randomised (n=58, BM-MSC group; n=56, sham placebo group). At 12 months, the primary outcome was not reached (74% in the BM-MSC group vs 69% in the placebo group; p=0.77). The groups did not differ in all secondary outcomes. No SAE related to the intervention occurred.
CONCLUSIONS: While our study did not conclusively demonstrate the efficacy of allogeneic BM-MSCs for LBP, the procedure was safe. Long-term outcomes of MSC therapy for LBP are still being studied.
TRIAL REGISTRATION NUMBER: EudraCT 2017-002092-25/ClinicalTrials.gov: NCT03737461.
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
This is a well done study with major significance (despite the technique being something not yet widely available to practitioners in the US)!
Physician rater
This is a well done study with major significance!
Physician rater
This long and complex study of 114 patients assigned 1/2 to allogenic stem cells injected into disk spaces of symptomatic people with low-back pain and 1/2 to sham injections. They could not demonstrate any significant benefit. The stem cells were harvested from 3 volunteers and grown in special media and sent to the various clinics for injection.
Physician rater
This study assessed the efficacy of a single intradiscal injection of allogeneic bone marrow mesenchymal stromal cells (BM-MSCs) versus a sham placebo in patients with chronic low back pain (LBP). The results showed that the intervention was not effective in patients with chronic low back pain. The study seems to have enough statistical power to detect clinically important differences. Since the lack of blinding of the surgeon/radiologist who performed the injection could have biased the study in favor of the intervention, the negative results seem to be valid. As the authors stated, chronic low back pain is multifactorial. Considering previous literature, the pre-test probability of a positive result was low.
, McMaster University