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Cited by 118Osteoarthritis Treatment and MechanismsPeriodontal Regeneration and TreatmentsMesenchymal stem cell research

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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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Lamo-Espinosa, José María, Blanco, Juan F., Sánchez, Mikel, Moreno, Victoria, Granero-Moltó, Froilán, Sánchez-Guijo, Fermín, Crespo-Cullel, Íñigo, Mora, Gonzalo, San Vicente, Diego Delgado, Pompei-Fernández, Orlando, Aquerreta, Jesús Dámaso, Núñez-Córdoba, Jorge María, Vitoria Sola, María, Valentí-Azcárate, Andrés, Andreu, Enrique J., del Consuelo del Cañizo, María, Valentí-Nin, Juan Ramón, Prósper, Felipe·2020·Journal of Translational Medicine
DOI 10.1186/s12967-020-02530-6PMC PMC7501623

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Abstract

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 100x10 6 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 100x10 6 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 between groups statistically significances 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.

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Authors
Lamo-Espinosa, J. M., Blanco, J. F., Sánchez, M., Moreno, V., Granero-Moltó, F., Sánchez-Guijo, F., Crespo-Cullel, Í., Mora, G., San Vicente, D. D., Pompei-Fernández, O., Aquerreta, J. D., Núñez-Córdoba, J. M., Vitoria Sola, M., Valentí-Azcárate, A., Andreu, E. J., del Consuelo del Cañizo, M., Valentí-Nin, J. R., & Prósper, F.
Affiliations
  • Clinica Universidad de Navarra (ES)
  • Instituto de Investigación Biomédica de Salamanca (ES)
Corresponding author
  • Lamo-Espinosa, José María
  • Prósper, Felipe
ORCID
Venue
Journal of Translational Medicine
Publisher
Springer Science and Business Media LLC
Published
2020-09-18
Volume
18
Issue
1
Pages
356-356
ISSN
1479-5876 (ISSN-L)
DOI
10.1186/s12967-020-02530-6
PMC
PMC7501623
OpenAlex
W3087236206
Cited by
118
References
1
Citations by year
2026: 11 · 2025: 24 · 2024: 27 · 2023: 19 · 2022: 24 · 2021: 12 · 2020: 1
FWCI
10.55
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Translational Medicine (publishedVersion, cc-by)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Hispana (submittedVersion)
Funders
Instituto de Salud Carlos III (RD16/0011, RD16/0011/0015, PI17/00136, RD16/0011/0005)
Topics
  • Health Sciences › Medicine › Rheumatology › Osteoarthritis Treatment and Mechanisms
  • Health Sciences › Dentistry › Periodontics › Periodontal Regeneration and Treatments
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › Mesenchymal stem cell research
Keywords
knee osteoarthritis, bone marrow mesenchymal stromal cells, intra-articular injection, autologous cell therapy, combination therapy, pain and function outcomes, knee range of motion, joint space narrowing, cartilage damage, treatment responders, safety and tolerability, WOMAC, VAS pain score, worms
MeSH terms
Humans, Injections, Intra-Articular, Treatment Outcome, Osteoarthritis, Knee, Mesenchymal Stem Cell Transplantation, Platelet-Rich Plasma, Mesenchymal Stem Cells

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