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Abstract
This phase I clinical trial evaluated the safety and clinical efficacy of adipose-derived stromal cells (ASCs) in osteoarthritis. Eighteen patients with severe knee osteoarthritis were treated with a single intra-articular injection of autologous ASCs at low (2 × 106 cells), medium (10 × 106), or high (50 × 106) doses (n = 6 each). After 6 months, no serious adverse events were reported, and patients treated with low-dose ASCs significantly improved in pain and function.
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Details
1 Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, Lapeyronie University Hospital, Montpellier, France; INSERM, U1183, Saint-Eloi Hospital, Montpellier, France
2 Department of Orthopaedic Surgery, König-Ludwig-Haus, University of Würzburg, Würzburg, Germany
3 Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, Lapeyronie University Hospital, Montpellier, France
4 Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB, Translational Center “Regenerative Therapies for Oncology and Musculoskeletal Diseases,” Würzburg, Germany
5 Department for Cell and Tissue Pathobiology of Tumor, Hospital Saint Eloi, Montpellier, France
6 Regenerative Medicine Institute, Galway University, Galway, Ireland
7 Etablissement Français du Sang, Toulouse, France
8 INSERM U1031 STROMAlab, Toulouse, France; CNRS, Université Toulouse III, UPS UMR5273 F-31 432 STROMAlab, Toulouse, France
9 Etablissement Français du Sang, Toulouse, France; INSERM U1031 STROMAlab, Toulouse, France; CNRS, Université Toulouse III, UPS UMR5273 F-31 432 STROMAlab, Toulouse, France
10 Etablissement Français du Sang, Toulouse, France; Univercell Biosolutions, Toulouse, France
11 INSERM, U1183, Saint-Eloi Hospital, Montpellier, France
12 Department of Orthopaedic Surgery, Lapeyronie University Hospital, Montpellier, France
13 Department of Radiology, Lapeyronie Hospital, Montpellier, France
14 Laboratory of Immunorheumatology and Tissue Regeneration, Istituto Ortopedico Rizzoli, Bologna, Italy
15 MRB Research Center Magnetic Resonance Bavaria, Würzburg, Germany
16 Maxillofacial, Plastic Reconstructive, and Aesthetic Surgery Department, Gui de Chauliac Hospital, Montpellier, France