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: Yves-Marie Pers, Robert Soler-Rich, Gianluca Vadalà, Rosanna Ferreira, Claire Duflos, Marie-Christine Picot, Fanchon Herman, Sylvie Broussous, Ana Sánchez, David Noriega, Francisco Ardura, Mercedes Alberca Zaballos, Verónica García, Virginia Gordillo Cano, Margarita González-Vallinas, Vicenzo Denaro, Fabrizio Russo, Jérôme Guicheux, Joan Vilanova, Lluís Orozco, Hans-Jörg Meisel, Matias Alfonso, Francois Rannou, Yves Maugars, Francis Berenbaum, Frank P Barry, Karin Tarte, Pascale Louis-Plence, Guilherme Ferreira-Dos-Santos, Javier García-Sancho, Christian Jorgensen, Yann Thouvenin, Catherine Cyteval, Michelle Moya, Sophie Grasset, Wendy Renier, Grégoire Mercier, Fanny Cardon, Perrine Robin, Aziza Seddiki, Alban Pouvreau, Mathilde Buisson, Céline Engrand, Felipe Prosper Cardoso, Esther Herrmann, Caroline Parlier Cuau, Xavier Alomar Serrallach, Antoine Feydy, Frédérique Toulgoat, Danièle Noël, Guillaum Costecalde, Phillipe Bourin, Carlo C. Quattrocchi, Abby Binch, Christian Hohaus, Joelle Dulong, Amelie Michon, Jimena Bouzas, Louis Casteilla, Christian Ruckes, Regina Kucharski, Claudia Cicione, Giuseppina Di Giacomo, Giorgia Petrucci, Veronica Tilotta, Francesca Cannata, Luca Ambrosio, Massimiliano Carassiti, Cécile Boyer, Eric Bord, Kevin Buffenoir, Johann Clouet
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Objectives</h3> 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). <h3>Methods</h3> 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. <h3>Results</h3> 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. <h3>Conclusions</h3> 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. <h3>Trial registration number</h3> EudraCT 2017-002092-25/ClinicalTrials.gov: NCT03737461.