Phase II multicenter randomized controlled clinical trial on the efficacy of intra-articular injection of autologous bon
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urnal of Translational Medicine Open Access
RESEARCH
Phase II multicenter randomized controlled clinical trial on the efficacy of intra‑articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma for the treatment of knee osteoarthritis José María Lamo‑Espinosa1,2* , Juan F. Blanco3, Mikel Sánchez4,5, Victoria Moreno1, Froilán Granero‑Moltó1,2, Fermín Sánchez‑Guijo6, Íñigo Crespo‑Cullel3, Gonzalo Mora1, Diego Delgado San Vicente5, Orlando Pompei‑Fernández5, Jesús Dámaso Aquerreta7, Jorge María Núñez‑Córdoba8,9, María Vitoria Sola1, Andrés Valentí‑Azcárate1, Enrique J. Andreu2, María del Consuelo del Cañizo6, Juan Ramón Valentí‑Nin1 and Felipe Prósper2,10*
Abstract Background: Mesenchymal stromal cells are a safe and promising option to treat knee osteoarthritis as previously demonstrated in different clinical trials. However, their efficacy, optimal dose and addition of adjuvants must be determined. Here, we evaluated the clinical effects of a dose of 100 × 106 bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF®) as adjuvant in a randomized clinical trial. Methods: A phase II, multicenter, randomized clinical trial with active control was conducted. Sixty patients diag‑ nosed with knee OA were randomly assigned to 3 weekly doses of PRGF® or intraarticular administration of 100 × 106 cultured autologous BM-MSCs plus PRGF®. Patients were followed up for 12 months, and pain and function were assessed using VAS and WOMAC and by measuring the knee range of motion range. X-ray and magnetic resonance imaging analyses were performed to analyze joint damage. Results: No adverse effects were reported after BM-MSC administration or during follow-up. According to VAS, the mean value (SD) for PRGF® and BM-MSC with PRGF® went from 5 (1.8) to 4.5 (2.2) (p = 0.389) and from 5.3 (1.9) to 3.5 (2.5) (p = 0.01), respectively at 12 months. In WOMAC, the mean (SD) baseline and 12-month overall WOMAC scores in patients treated with PRGF® was 31.9 (16.2) and 22.3 (15.8) respectively (p = 0.002) while that for patients treated with BM-MSC plus PRGF® was 33.4 (18.7) and 23.0 (16.6) (p = 0.053). Although statistical significances between groups have been not detected, only patients being treated with BM-MSC plus PRGF® could be considered as a OA
*Correspondence: [email protected]; [email protected] 1 Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008 Pamplona, Spain 2 Cell Therapy Area, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008 Pamplona, Spain Full list of author information is available at the end of the article © The Author(s) 2020. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The imag
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