| Title: |
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: |
Pers, Yves-Marie; Soler-Rich, Robert; Vadalà, Gianluca; Ferreira, Rosanna; Duflos, Claire; Picot, Marie-Christine; Herman, Fanchon; Broussous, Sylvie; Sánchez, Ana; Noriega, David; Ardura, Francisco; Alberca Zaballos, Mercedes; García, Verónica; Gordillo Cano, Virginia; González-Vallinas, Margarita; Denaro, Vicenzo; Russo, Fabrizio; Guicheux, Jérôme; Vilanova, Joan; Orozco, Lluís; Meisel, Hans-Jörg; Alfonso, Matias; Rannou, Francois; Maugars, Yves; Berenbaum, Francis; Barry, Frank; Tarte, Karin; Louis-Plence, Pascale; Ferreira-Dos-Santos, Guilherme; García-Sancho, Javier; Jorgensen, Christian |
| Contributors: |
Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB); Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM); Hôpital Lapeyronie CHU Montpellier; Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier); Quironsalud Teknon Heart Institute Barcelona, Spain (QTHI); Università Campus Bio-Medico di Roma / University Campus Bio-Medico of Rome (UCBM); Université de Montpellier (UM); IBGM, University of Valladolid; Hospital Clinico Universitario de Valladolid (HCUV); Rio Hortega University Hospital (Hospital Universitario Río Hortega) Valladolid, Spain (RHUH); Universidad de Valladolid Valladolid (UVa); Regenerative Medicine and Skeleton (RMeS); École nationale vétérinaire, agroalimentaire et de l'alimentation Nantes-Atlantique (ONIRIS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nantes Université - UFR Odontologie (Nantes Univ – UFR Odonto); Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ); Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes); University Hospital Halle; Clínica Universidad de Navarra Pamplona; Hôpital Cochin AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Hôtel-Dieu de Nantes; CHU Saint-Antoine AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); University of Galway; Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; Clinic Barcelona Hospital Universitari; Universitat Autònoma de Barcelona = Autonomous University of Barcelona = Universidad Autónoma de Barcelona (UAB); CHU Montpellier = Montpellier University Hospital; We thank Dr Virginie RENAC, Laboratory of Immunogeneticsand Histocompatibility, for providing data on immunogenicity of allogeneic BMMSCs by studying the emergence of donor specificities of anti-HLA class I andanti-HLA class II antibodies in patients injected with BM-MSCs. We acknowledgethe support of ECELLFrance ’The national research infrastructure for regenerativemedicine-MSC-based therapies’ (France 2030/ANR-11-INSB-005).; RESPINE consortium: 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 |
| Source: |
ISSN: 0003-4967. |
| Publisher Information: |
CCSD; BMJ Publishing Group |
| Publication Year: |
2024 |
| Collection: |
Université de Nantes: HAL-UNIV-NANTES |
| Subject Terms: |
Orthopedic Procedures; Low Back Pain; Biological Therapy; MESH: Humans; MESH: Low Back Pain; MESH: Double-Blind Method; MESH: Chronic Pain; MESH: Prospective Studies; MESH: Treatment Outcome; MESH: Pain Measurement; MESH: Transplantation; Homologous; MESH: Mesenchymal Stem Cell Transplantation; MESH: Female; MESH: Male; MESH: Middle Aged; MESH: Adult; [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| Description: |
Trial registration number EudraCT 2017-002092-25/ClinicalTrials.gov: NCT03737461. ; International audience ; 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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/39393844; PUBMED: 39393844; PUBMEDCENTRAL: PMC11503111 |
| DOI: |
10.1136/ard-2024-225771 |
| Availability: |
https://hal.science/hal-04901767; https://hal.science/hal-04901767v1/document; https://hal.science/hal-04901767v1/file/ard-83-11.pdf; https://doi.org/10.1136/ard-2024-225771 |
| Rights: |
http://creativecommons.org/licenses/by-nc/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.6A4BEE64 |
| Database: |
BASE |