ARTÍCULO

Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: long-term follow up of a multicenter randomized controlled clinical trial (phase I/II)

Autores: Lamo de Espinosa Vázquez de Sola, José María; Mora Gasque, Gonzalo; Blanco, J. F.; Granero Moltó, Froilán; Núñez Córdoba, Jorge María; Lopez-Elio, S.; Andreu Oltra, Enrique José; Sanchez-Guijo, F. ; Aquerreta Beola, Jesús Dámaso; Bondia Gracia, José María; Valentí Azcárate, Andrés; del Canizo, M. C.; Villaron, E. M. ; Valentí Nín, Juan Ramón; Prósper Cardoso, Felipe Luis (Autor de correspondencia)
Título de la revista: JOURNAL OF TRANSLATIONAL MEDICINE
ISSN: 1479-5876
Volumen: 16
Páginas: 213
Fecha de publicación: 2018
Lugar: WOS
Resumen:
Background: Mesenchymal stromal cells (MSCs) are a promising option to treat knee osteoarthritis (OA). Their safety and usefulness have been reported in several short-term clinical trials but less information is available on the long-term effects of MSC in patients with osteoarthritis. We have evaluated patients included in our previous randomized clinical trial (CMM-ART, NCT02123368) to determine their long-term clinical effect. Materials: A phase I/II multicenter randomized clinical trial with active control was conducted between 2012 and 2014. Thirty patients diagnosed with knee OA were randomly assigned to Control group, intraarticularly administered hyaluronic acid alone, or to two treatment groups, hyaluronic acid together with 10 x 10(6) or 100 x 10(6) cultured autologous bone marrow-derived MSCs (BM-MSCs), and followed up for 12 months. After a follow up of 4 years adverse effects and clinical evolution, assessed using VAS and WOMAC scorings are reported. Results: No adverse effects were reported after BM-MSCs administration or during the follow-up. BM-MSCs-administered patients improved according to VAS, median value (IQR) for Control, Low-dose and High-dose groups changed from 5 (3, 7), 7 (5, 8) and 6 (4, 8) to 7 (6, 7), 2 (2, 5) and 3 (3, 4), respectively at the end of follow up (Low-dose vs Control group, p = 0.01; High-dose vs Control group, p = 0.004). Patients receiving BM-MSCs also improved clinically according to WOMAC. Control group showed an increase median value of 4 points (-11;10) while Low-dose and High-dose groups exhibited values of -18 (-28;-9) and -10 (-21;-3) points, respectively (Low-dose vs Control group p = 0.043). No clinical differences between the BM-MSCs receiving groups were found. Conclusions: Single intraarticular injection of in vitro expanded autologous BM-MSCs is a safe and feasible procedure that results in long-term clinical and functional improvement of knee OA.