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, David
A1 Ardura, Francisco
A1 Alberca Zaballos, Mercedes
A1 García, Verónica
A1 Gordillo Cano, Virginia
A1 González-Vallinas, Margarita
A1 Denaro, Vicenzo
A1 Russo, Fabrizio
A1 Guicheux, Jérôme
A1 Vilanova, Joan
A1 Orozco, Lluís
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, 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 Octubre 2024, vol. 83, no 11, p. 1572-1583.
NO Producción Científica
DS UVaDOC
RD 23-ene-2026