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

Lamo de Espinosa Vázquez de Sola, José María; Blanco, Juan F.; Sánchez, Mikel; Moreno, Victoria; Granero-Moltó, Froilán; Sanchez-Guijo, Fermín; Crespo‑Cullel, Íñigo; Mora, Gonzalo; Delgado San Vicente, Diego; Pompei‑Fernández, Orlando; Dámaso Aquerreta, Jesús; Núñez‑Córdoba, Jorge María; Sola, María Vitoria; Valentí-Azcárate, Andrés; Andreu, Enrique J.; del Cañizo, María del Consuelo; Valentí‑Nin, Juan Ramón; Prosper, Felipe

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

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 × 1...

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Autores:	Lamo de Espinosa Vázquez de Sola, José María, Blanco, Juan F., Sánchez, Mikel, Moreno, Victoria, Granero-Moltó, Froilán, Sanchez-Guijo, Fermín, Crespo‑Cullel, Íñigo, Mora, Gonzalo, Delgado San Vicente, Diego, Pompei‑Fernández, Orlando, Dámaso Aquerreta, Jesús, Núñez‑Córdoba, Jorge María, Sola, María Vitoria, Valentí-Azcárate, Andrés, Andreu, Enrique J., del Cañizo, María del Consuelo, Valentí‑Nin, Juan Ramón, Prosper, Felipe
Tipo de recurso:	artículo
Fecha de publicación:	2020
País:	España
Institución:	Universidad Católica de Valencia San Vicente Mártir
Repositorio:	RIUCV. Repositorio de la Universidad Católica de Valencia San Vicente Mártir
Idioma:	inglés
OAI Identifier:	oai:riucv.ucv.es:20.500.12466/5308
Acceso en línea:	http://hdl.handle.net/20.500.12466/5308
Access Level:	acceso abierto
Palabra clave:	Marrow-mesenchymal stromal cells Knee osteoarthritis Non-surgical management Stem cell therapy 32 Ciencias Médicas

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spelling	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 osteoarthritisLamo de Espinosa Vázquez de Sola, José MaríaBlanco, Juan F.Sánchez, MikelMoreno, VictoriaGranero-Moltó, FroilánSanchez-Guijo, FermínCrespo‑Cullel, ÍñigoMora, GonzaloDelgado San Vicente, DiegoPompei‑Fernández, OrlandoDámaso Aquerreta, JesúsNúñez‑Córdoba, Jorge MaríaSola, María VitoriaValentí-Azcárate, AndrésAndreu, Enrique J.del Cañizo, María del ConsueloValentí‑Nin, Juan RamónProsper, FelipeMarrow-mesenchymal stromal cellsKnee osteoarthritisNon-surgical managementStem cell therapy32 Ciencias MédicasBackground: 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 diagnosed 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 treatment responders following OARSI criteria. X-ray and MRI (WORMS protocol) revealed no changes in knee joint space width or joint damage. Conclusions: Treatment with BM-MSC associated with PRGF® was shown to be a viable therapeutic option for osteoarthritis of the knee, with clinical improvement at the end of follow-up. Further phase III clinical trials would be necessary to confirm the efficacy. Trial registration Clinical Trials.gov identifier NCT02365142. Nº EudraCT: 2011-006036-2320252025-01-2720202020-09-1820202020-09-18journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/20.500.12466/5308reponame:RIUCV. Repositorio de la Universidad Católica de Valencia San Vicente Mártirinstname:Universidad Católica de Valencia San Vicente MártirInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internacionalhttp://creativecommons.org/licenses/byd/4.0/info:eu-repo/semantics/openAccessoai:riucv.ucv.es:20.500.12466/53082026-06-19T08:32:07Z
dc.title.none.fl_str_mv	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
title	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
spellingShingle	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 Lamo de Espinosa Vázquez de Sola, José María Marrow-mesenchymal stromal cells Knee osteoarthritis Non-surgical management Stem cell therapy 32 Ciencias Médicas
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
dc.creator.none.fl_str_mv	Lamo de Espinosa Vázquez de Sola, José María Blanco, Juan F. Sánchez, Mikel Moreno, Victoria Granero-Moltó, Froilán Sanchez-Guijo, Fermín Crespo‑Cullel, Íñigo Mora, Gonzalo Delgado San Vicente, Diego Pompei‑Fernández, Orlando Dámaso Aquerreta, Jesús Núñez‑Córdoba, Jorge María Sola, María Vitoria Valentí-Azcárate, Andrés Andreu, Enrique J. del Cañizo, María del Consuelo Valentí‑Nin, Juan Ramón Prosper, Felipe
author	Lamo de Espinosa Vázquez de Sola, José María
author_facet	Lamo de Espinosa Vázquez de Sola, José María Blanco, Juan F. Sánchez, Mikel Moreno, Victoria Granero-Moltó, Froilán Sanchez-Guijo, Fermín Crespo‑Cullel, Íñigo Mora, Gonzalo Delgado San Vicente, Diego Pompei‑Fernández, Orlando Dámaso Aquerreta, Jesús Núñez‑Córdoba, Jorge María Sola, María Vitoria Valentí-Azcárate, Andrés Andreu, Enrique J. del Cañizo, María del Consuelo Valentí‑Nin, Juan Ramón Prosper, Felipe
author_role	author
author2	Blanco, Juan F. Sánchez, Mikel Moreno, Victoria Granero-Moltó, Froilán Sanchez-Guijo, Fermín Crespo‑Cullel, Íñigo Mora, Gonzalo Delgado San Vicente, Diego Pompei‑Fernández, Orlando Dámaso Aquerreta, Jesús Núñez‑Córdoba, Jorge María Sola, María Vitoria Valentí-Azcárate, Andrés Andreu, Enrique J. del Cañizo, María del Consuelo Valentí‑Nin, Juan Ramón Prosper, Felipe
author2_role	author author author author author author author author author author author author author author author author author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv	Marrow-mesenchymal stromal cells Knee osteoarthritis Non-surgical management Stem cell therapy 32 Ciencias Médicas
topic	Marrow-mesenchymal stromal cells Knee osteoarthritis Non-surgical management Stem cell therapy 32 Ciencias Médicas
description	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 diagnosed 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 treatment responders following OARSI criteria. X-ray and MRI (WORMS protocol) revealed no changes in knee joint space width or joint damage. Conclusions: Treatment with BM-MSC associated with PRGF® was shown to be a viable therapeutic option for osteoarthritis of the knee, with clinical improvement at the end of follow-up. Further phase III clinical trials would be necessary to confirm the efficacy. Trial registration Clinical Trials.gov identifier NCT02365142. Nº EudraCT: 2011-006036-23
publishDate	2020
dc.date.none.fl_str_mv	2020 2020-09-18 2020 2020-09-18 2025 2025-01-27
dc.type.none.fl_str_mv	journal article http://purl.org/coar/resource_type/c_6501 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv	info:eu-repo/semantics/article
format	article
dc.identifier.none.fl_str_mv	http://hdl.handle.net/20.500.12466/5308
url	http://hdl.handle.net/20.500.12466/5308
dc.language.none.fl_str_mv	Inglés eng
language_invalid_str_mv	Inglés
language	eng
dc.rights.none.fl_str_mv	open access http://purl.org/coar/access_right/c_abf2 Attribution 4.0 Internacional http://creativecommons.org/licenses/byd/4.0/
dc.rights.openaire.fl_str_mv	info:eu-repo/semantics/openAccess
rights_invalid_str_mv	open access http://purl.org/coar/access_right/c_abf2 Attribution 4.0 Internacional http://creativecommons.org/licenses/byd/4.0/
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.source.none.fl_str_mv	reponame:RIUCV. Repositorio de la Universidad Católica de Valencia San Vicente Mártir instname:Universidad Católica de Valencia San Vicente Mártir
instname_str	Universidad Católica de Valencia San Vicente Mártir
reponame_str	RIUCV. Repositorio de la Universidad Católica de Valencia San Vicente Mártir
collection	RIUCV. Repositorio de la Universidad Católica de Valencia San Vicente Mártir
repository.name.fl_str_mv
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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

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