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)
Abstract 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 ha...
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| Format: | Article |
| Language: | English |
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BMC
2018-07-01
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| Series: | Journal of Translational Medicine |
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| Online Access: | http://link.springer.com/article/10.1186/s12967-018-1591-7 |
| _version_ | 1818298367521849344 |
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| author | José María Lamo-Espinosa Gonzalo Mora Juan F. Blanco Froilán Granero-Moltó Jorge María Núñez-Córdoba Silvia López-Elío Enrique Andreu Fermín Sánchez-Guijo José Dámaso Aquerreta José María Bondía Andrés Valentí-Azcárate María del Consuelo del Cañizo Eva María Villarón Juan Ramón Valentí-Nin Felipe Prósper |
| author_facet | José María Lamo-Espinosa Gonzalo Mora Juan F. Blanco Froilán Granero-Moltó Jorge María Núñez-Córdoba Silvia López-Elío Enrique Andreu Fermín Sánchez-Guijo José Dámaso Aquerreta José María Bondía Andrés Valentí-Azcárate María del Consuelo del Cañizo Eva María Villarón Juan Ramón Valentí-Nin Felipe Prósper |
| author_sort | José María Lamo-Espinosa |
| collection | DOAJ |
| description | Abstract 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 × 106 or 100 × 106 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. |
| first_indexed | 2024-12-13T04:34:12Z |
| format | Article |
| id | doaj.art-6476cf49fb4e401b85140f88e3f5fc2b |
| institution | Directory Open Access Journal |
| issn | 1479-5876 |
| language | English |
| last_indexed | 2024-12-13T04:34:12Z |
| publishDate | 2018-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Translational Medicine |
| spelling | doaj.art-6476cf49fb4e401b85140f88e3f5fc2b2022-12-21T23:59:28ZengBMCJournal of Translational Medicine1479-58762018-07-011611510.1186/s12967-018-1591-7Intra-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)José María Lamo-Espinosa0Gonzalo Mora1Juan F. Blanco2Froilán Granero-Moltó3Jorge María Núñez-Córdoba4Silvia López-Elío5Enrique Andreu6Fermín Sánchez-Guijo7José Dámaso Aquerreta8José María Bondía9Andrés Valentí-Azcárate10María del Consuelo del Cañizo11Eva María Villarón12Juan Ramón Valentí-Nin13Felipe Prósper14Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de NavarraDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de NavarraDepartment of Traumatology, Complejo Hospitalario de SalamancaDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de NavarraDivision of Biostatistics, Research Support Service, Central Clinical Trials Unit, University of Navarra ClinicDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de NavarraCell Therapy Area, Clínica Universidad de NavarraDepartment of Hematology, Complejo Hospitalario de SalamancaDepartment of Radiology, Clínica Universidad de NavarraDepartment of Radiology, Clínica Universidad de NavarraDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de NavarraDepartment of Hematology, Complejo Hospitalario de SalamancaDepartment of Hematology, Complejo Hospitalario de SalamancaDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de NavarraCell Therapy Area, Clínica Universidad de NavarraAbstract 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 × 106 or 100 × 106 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.http://link.springer.com/article/10.1186/s12967-018-1591-7Knee osteoarthritisMesenchymal stem cellsIntraarticular injection |
| spellingShingle | José María Lamo-Espinosa Gonzalo Mora Juan F. Blanco Froilán Granero-Moltó Jorge María Núñez-Córdoba Silvia López-Elío Enrique Andreu Fermín Sánchez-Guijo José Dámaso Aquerreta José María Bondía Andrés Valentí-Azcárate María del Consuelo del Cañizo Eva María Villarón Juan Ramón Valentí-Nin Felipe Prósper 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) Journal of Translational Medicine Knee osteoarthritis Mesenchymal stem cells Intraarticular injection |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Knee osteoarthritis Mesenchymal stem cells Intraarticular injection |
| url | http://link.springer.com/article/10.1186/s12967-018-1591-7 |
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