| Title: |
Effect of intra-articular adipose-derived mesenchymal stromal cell versus placebo injection on pain and function in patients with knee osteoarthritis: the ADIPOA2 phase 2b randomised clinical trial |
| Authors: |
Pers, Yves-Marie; Schrezenmeier, Hubert; Fleury-Cappellesso, Sandrine; Nöth, Ulrich; Rackwitz, Lars; Ferreira, Rosanna; Berenbaum, Francis; Ruyssen-Witrand, Adeline; Thurlings, Rogier Martijn; Addimanda, Olga; Lisignoli, Gina; Ramonda, Roberta; Shannon, Fintan; Punzi, Leonardo; Baillet, Athan; McCaskie, Andrew W; McDonnell, Stephen; O'Callaghan, Jenny; Turmezei, Tom; Kessler, Dimitri A; Lotfi, Ramin; Rojewski, Markus; Duffy, Aoife; Finnerty, Andrew; Moisan, Anaïck; Brochot-Dechet, Helene; Aubery-Rousselet, Mathilde; Michon, Amélie; Bouzas-Rodriguez, Jimena; Pullig, Oliver; Broussous, Sylvie; Nogue, Erika; Amico, Maïlis; Picot, Marie-Christine; Barry, Frank; Jorgensen, Christian |
| Contributors: |
Pers, Yves-Marie; Schrezenmeier, Hubert; Fleury-Cappellesso, Sandrine; Nöth, Ulrich; Rackwitz, Lar; Ferreira, Rosanna; Berenbaum, Franci; Ruyssen-Witrand, Adeline; Thurlings, Rogier Martijn; Addimanda, Olga; Lisignoli, Gina; Ramonda, Roberta; Shannon, Fintan; Punzi, Leonardo; Baillet, Athan; Mccaskie, Andrew W; Mcdonnell, Stephen; O'Callaghan, Jenny; Turmezei, Tom; Kessler, Dimitri A; Lotfi, Ramin; Rojewski, Marku; Duffy, Aoife; Finnerty, Andrew; Moisan, Anaïck; Brochot-Dechet, Helene; Aubery-Rousselet, Mathilde; Michon, Amélie; Bouzas-Rodriguez, Jimena; Pullig, Oliver; Broussous, Sylvie; Nogue, Erika; Amico, Maïli; Picot, Marie-Christine; Barry, Frank; Jorgensen, Christian |
| Publisher Information: |
Elsevier B.V. |
| Publication Year: |
2025 |
| Collection: |
Padua Research Archive (IRIS - Università degli Studi di Padova) |
| Description: |
Objectives: This study aims to evaluate the efficacy of intra-articular autologous adipose-derived ex vivo expanded mesenchymal stromal cells (ADSC) on patient-reported outcome (pain and function) in symptomatic mild-to-moderate tibiofemoral knee osteoarthritis (OA). Methods: Participants were randomised in a prospective, double-blind, controlled phase 2b study to receive 1 single intra-articular injection in 3 separate groups: ADSC low dose 2 × 106 cells; ADSC high dose 10 × 106 cells; or saline placebo. The primary outcome was the rate of OsteoArthritis Research Society International (OARSI)/Outcome MEasures in Rheumatology (OMERACT) ‘strict responders’ defined by improvements from baseline reported to 0 to 100 mm scale in Western Ontario and McMaster University Osteoarthritis index (WOMAC) pain or physical function subscores ≥50% with minimal absolute changes ≥20 mm at 6 months. Secondary outcomes included an evaluation of WOMAC pain, WOMAC function, quality of life (36-Item Short Form Health Survey), WOMAC and Knee injury and OA Outcome Score global change, magnetic resonance imaging cartilage thickness changes and safety from baseline to 12-month follow-up. Results: One hundred thirty-five patients were randomised from September 2016 to March 2022 (mean age, 58.3 [SD, 6.5] years; 58 [43%] women), 99 (73%) received allocated intervention, and 97 were analysed. After 6 months, treatment with ADSC versus placebo injection, 26 patients (47.3%) versus 23 patients (54.8%) were strict OARSI/OMERACT responders (relative risk 0.86 [95% CI: 0.58-1.28]; P = .46). Individuals showed different patterns in cartilage thickness change between timepoints across tibiofemoral articular surfaces, but overall secondary outcomes showed no significant-group differences. Conclusions: Among patients with symptomatic mild-to-moderate knee OA, a single intra-articular injection of 2 × 106 or 10 × 106 autologous ADSC compared with injection of saline placebo did not significantly improve pain and function. Trial registration number: ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/40885690; info:eu-repo/semantics/altIdentifier/wos/WOS:001639733600001; journal:EARD; https://hdl.handle.net/11577/3562867 |
| DOI: |
10.1016/j.ard.2025.07.026 |
| Availability: |
https://hdl.handle.net/11577/3562867; https://doi.org/10.1016/j.ard.2025.07.026 |
| Accession Number: |
edsbas.B0BA76BA |
| Database: |
BASE |