Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial - Université de Montpellier Accéder directement au contenu
Article Dans Une Revue Stem Cells Translational Medicine Année : 2016

Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial

Oliver Pullig
  • Fonction : Auteur
Louis Casteilla
Sandrine Fleury
  • Fonction : Auteur
Philippe Bourin
  • Fonction : Auteur
EFS

Résumé

Osteoarthritis x Adipose mesenchymal stromal cells x Intra-articular injection x Therapeutic potential x Regenerative medicine x Phase I clinical trial ABSTRACT Osteoarthritis (OA) is the most widespread musculoskeletal disorder in adults. It leads to cartilage damage associated with subchondral bone changes and synovial inflammation, causing pain and disability. The present study aimed at evaluating the safety of a dose-escalation protocol of intra-articular injected adipose-derived stromal cells (ASCs) in patients with knee OA, as well as clinical efficacy as secondary endpoint. A bicentric, uncontrolled, open phase I clinical trial was conducted in France and Germany with regulatory agency approval for ASC expansion procedure in both countries. From April 2012 to December 2013, 18 consecutive patients with symptomatic and severe knee OA were treated with a single intra-articular injection of autologous ASCs. The study design consisted of three consecutive cohorts (six patients each) with dose escalation: low dose (2 3 10 6 cells), medium dose (10 3 10 6), and high dose (50 3 10 6). The primary outcome parameter was safety evaluated by recording adverse events throughout the trial, and secondary parameters were pain and function subscales of the Western Ontario and McMaster Universities Arthritis Index. After 6 months of follow-up, the procedure was found to be safe, and no serious adverse events were reported. Four patients experienced transient knee joint pain and swelling after local injection. Interestingly, patients treated with low-dose ASCs experienced significant improvements in pain levels and function compared with baseline. Our data suggest that the intraarticular injection of ASCs is a safe therapeutic alternative to treat severe knee OA patients. A placebo-controlled double-blind phase IIb study is being initiated to assess clinical and structural efficacy.
Fichier principal
Vignette du fichier
IRMB 57_p35_Adipose Mesenchymal Stromal Cell-BasedTherapy for Severe Osteoarthritis of the Knee_sctm_20150245.pdf (1.53 Mo) Télécharger le fichier
Origine Fichiers éditeurs autorisés sur une archive ouverte

Dates et versions

hal-01834263 , version 1 (27-01-2021)

Identifiants

Citer

Yves-Marie Pers, Lars Rackwitz, Rosanna Ferreira, Oliver Pullig, Christophe Delfour, et al.. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Translational Medicine, 2016, 5 (7), pp.847 - 856. ⟨10.5966/sctm.2015-0245⟩. ⟨hal-01834263⟩
212 Consultations
75 Téléchargements

Altmetric

Partager

Gmail Mastodon Facebook X LinkedIn More