Fibromyalgia & musculoskeletal pain
Allogenic bone marrow–derived mesenchymal stromal cell–based therapy for patients with chronic low back pain: a prospective, multicentre, randomised placebo controlled trial (RESPINE study)
Authors' conclusion
While our study did not conclusively demonstrate the efficacy of allogeneic BM-MSCs for LBP, the procedure was safe.
Study context
- Population
- Patients with chronic low back pain (LBP)randomised
- Participants
- 114 patients
- Comparison
- Single intradiscal injection of 20 million allogeneic BM-MSC vs sham injection
- BM-MSCn = 58
- Sham placebon = 56reference
- Primary endpoint
- Co-primary: responders (improvement of pain VAS of at least 20% and 20 mm, or ODI improvement of 20%) from baseline; structural co-primary: disc fluid content by quantitative MRI T2
- Follow-up
- Month 12
Methodological detailsdouble-blind, placebo-controlled, multicentre, prospective, Randomised between April 2018 and December 2022
- Double-blind
- Placebo-controlled
- Multicentre
- Prospective
- Randomised between April 2018 and December 2022
Primary result
As reported in the abstract
Responder rate · 12 months
P = 0.77
Secondary outcomes
All secondary outcomes (pain Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), SF-36, MCID at 1, 3, 6, 12 and 24 months)
- The groups did not differ in all secondary outcomes
Safety
- No SAE related to the intervention occurred
Original publication
Allogenic bone marrow–derived mesenchymal stromal cell–based therapy for patients with chronic low back pain: a prospective, multicentre, randomised placebo controlled trial (RESPINE study). Ann Rheum Dis. Published 21 October 2024. doi:10.
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