Scientific publications
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). Scientific Publication
Yves-Marie Pers 1 2 , Robert Soler-Rich 3 , Gianluca Vadalà 4 , Rosanna Ferreira 5 , Claire Duflos 6 , Marie-Christine Picot 7 , Fanchon Herman 8 , Sylvie Broussous 9 , Ana Sánchez 10 11 , David Noriega 12 , Francisco Ardura 12 , Mercedes Alberca Zaballos 11 13 , Verónica García 11 13 , Virginia Gordillo Cano 10 11 , Margarita González-Vallinas 11 13 , Vicenzo Denaro 14 , Fabrizio Russo 14 , Jérôme Guicheux 15 , Joan Vilanova 16 , Lluís Orozco 3 , Hans-Jörg Meisel 17 , Matias Alfonso 18 , Francois Rannou 19 , Yves Maugars 15 20 , Francis Berenbaum 21 , Frank P Barry 22 , Karin Tarte 23 , Pascale Louis-Plence 2 , Guilherme Ferreira-Dos-Santos 3 24 , Javier García-Sancho 11 13 , Christian Jorgensen 25 26 ; RESPINE consortium
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.
CITATION Ann Rheum Dis. 2024 Oct 11:ard-2024-225771. doi: 10.1136/ard-2024-225771
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