RT info:eu-repo/semantics/article
T1 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)
A1 Pers, Yves-Marie
A1 Soler-Rich, Robert
A1 Vadalà, Gianluca
A1 Ferreira, Rosanna
A1 Duflos, Claire
A1 Picot, Marie-Christine
A1 Herman, Fanchon
A1 Broussous, Sylvie
A1 Sánchez, Ana
A1 Noriega González, David César
A1 Ardura Aragón, Francísco
A1 Alberca Zaballos, María Mercedes
A1 García Diaz, Verónica
A1 Gordillo Cano, Virginia
A1 González-Vallinas Garrachón, Margarita
A1 Denaro, Vicenzo
A1 Russo, Fabrizio
A1 Guicheux, Jérôme
A1 Vilanova, Joan
A1 Orozco, Lluis
A1 Meisel, Hans-Jörg
A1 Alfonso, Matias
A1 Rannou, Francois
A1 Maugars, Yves
A1 Berenbaum, Francis
A1 Barry, Frank P
A1 Tarte, Karin
A1 Louis-Plence, Pascale
A1 Ferreira-Dos-Santos, Guilherme
A1 García-Sancho Martín, Francisco Javier
A1 Jorgensen, Christian
A1 RESPINE consortium
K1 Low back pain
K1 Biological therapy
K1 Orthopedic procedures
K1 Mesenchymal stem cell
AB 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-primaryendpoint 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-MSCsfor 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.
PB British Medical Journal (BMJ) group
SN 0003-4967
YR 2024
FD 2024
LK https://uvadoc.uva.es/handle/10324/81998
UL https://uvadoc.uva.es/handle/10324/81998
LA eng
NO Ann Rheum Dis, 2024, vol. 83, no 11, p. 1572-1583.
NO Producción Científica
DS UVaDOC
RD 19-abr-2026