Evidence map›Paper›PMID 32948200›Full record

Trial reportJournal of translational medicine2020

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-Espinosa, Juan F Blanco, Mikel Sánchez, Victoria Moreno, Froilán Granero-Moltó, Fermín Sánchez-Guijo, Íñigo Crespo-Cullel, Gonzalo Mora, Diego Delgado San Vicente, Orlando Pompei-Fernández and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02365142 (Phase I/II. Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma), which is not on this map. Cited by 74 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 13 pooled it
12.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02365142 phase1 / phase2unknown statusnot on this map

Phase I/II. Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma(PRGF)

TypeinterventionalSponsorClinica Universidad de Navarra, Universidad de NavarraRan2014 to 2018Enrolled38ConditionsKnee OsteoarthritisArms100 million Bone marrow mesenchimal stem cells, Platelet Rich plasma (PRGF)
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 13 syntheses or guidelines pooled it, 111 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Stem cell injections for osteoarthritis of the knee.The Cochrane database of systematic reviews · 2025
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Trial
  15. Trial
  16. Article
  17. Article
  18. Review
  19. Review
  20. Review

14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 3 institutions in 1 country.

José María Lamo-EspinosaDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain. jlamodeespi@unav.es.ORCID 0000-0002-9696-2620
Juan F BlancoDepartment of Orthopaedic Surgery and Traumatology, Complejo Universitario de Salamanca-IBSAL, Salamanca, Spain.
Mikel SánchezArthroscopic Surgery Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.
Victoria MorenoDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.
Froilán Granero-MoltóDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.
Fermín Sánchez-GuijoDepartment of Haematology, Complejo Hospitalario de Salamanca-IBSAL, Salamanca, Spain.
Íñigo Crespo-CullelDepartment of Orthopaedic Surgery and Traumatology, Complejo Universitario de Salamanca-IBSAL, Salamanca, Spain.
Gonzalo MoraDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.
Diego Delgado San VicenteAdvanced Biological Therapy Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.
Orlando Pompei-FernándezAdvanced Biological Therapy Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.
Jesús Dámaso AquerretaDepartment of Radiology, Clínica Universidad de Navarra, Pamplona, Spain.
Jorge María Núñez-CórdobaDivision of Biostatistics, Research Support Service, Central Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain.
María Vitoria SolaDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.
Andrés Valentí-AzcárateDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.
Enrique J AndreuCell Therapy Area, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.
María Del Consuelo Del CañizoDepartment of Haematology, Complejo Hospitalario de Salamanca-IBSAL, Salamanca, Spain.
Juan Ramón Valentí-NinDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.
Felipe PrósperCell Therapy Area, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain. fprosper@unav.es.
Clinica Universidad de Navarra · ESComplejo Hospitalario de Salamanca · ESUnidad de Cirugía Artroscópica · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMesenchymal 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 × 10

methodsA 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 × 10

resultsNo 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.

conclusionsTreatment 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.

Indexed as

Mesenchymal Stem CellsMesenchymal Stem Cell TransplantationOsteoarthritis, KneePlatelet-Rich PlasmaHumansInjections, Intra-ArticularTreatment OutcomeBone marrow-mesenchymal stromal cellsKnee osteoarthritisNon-surgical managementStem cell therapy

Identifiers

PMID32948200
PMCPMC7501623
OpenAlexW3087236206

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.