Evidence map›Paper›PMID 30064455›Full record

Trial reportJournal of translational medicine2018

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).

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 and 5 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of translational medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 90 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 9 pooled it
14.6field-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.

NCT02123368 phase1 / phase2completednot on this map

Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells

TypeinterventionalSponsorClinica Universidad de Navarra, Universidad de NavarraRan2012 to 2015Enrolled30ConditionsOsteoarthritisArmsHyaluronic acid, 10 million Bone marrow mesenchimal stem cells, 100 million Bone marrow mesenchimal stem cells
NCT05660824 phase4not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Effectiveness of Stromal Vascular Fraction (SVF) and Platelet -Rich Plasma (PRP) in Patients With Knee Osteoarthritis: Study Protocol for a Phase III, Prospective, Randomized, Controlled Multi-center Study : (SPOST Study)

TypeinterventionalSponsorAdrien SchwitzguebelRan2025 to 2027Enrolled108ConditionsOsteoarthritisArmsStromal Vascular Fraction infiltration, Plattelet Rich Plasma infiltration
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 9 syntheses or guidelines pooled it, 187 citations in OpenAlex.

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  3. Stem cell injections for osteoarthritis of the knee.The Cochrane database of systematic reviews · 2025
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30 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

15 authors at 3 institutions in 1 country.

José María Lamo-EspinosaDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, Pamplona, Spain.
Gonzalo MoraDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, Pamplona, Spain.
Juan F BlancoDepartment of Traumatology, Complejo Hospitalario de Salamanca, Salamanca, Spain.
Froilán Granero-MoltóDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, Pamplona, Spain.
Jorge María Núñez-CórdobaDivision of Biostatistics, Research Support Service, Central Clinical Trials Unit, University of Navarra Clinic, Pamplona, Spain.
Silvia López-ElíoDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, Pamplona, Spain.
Enrique AndreuCell Therapy Area, Clínica Universidad de Navarra, Pamplona, Spain.
Fermín Sánchez-GuijoDepartment of Hematology, Complejo Hospitalario de Salamanca, Salamanca, Spain.
José Dámaso AquerretaDepartment of Radiology, Clínica Universidad de Navarra, Pamplona, Spain.
José María BondíaDepartment of Radiology, Clínica Universidad de Navarra, Pamplona, Spain.
Andrés Valentí-AzcárateDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, Pamplona, Spain.
María Del Consuelo Del CañizoDepartment of Hematology, Complejo Hospitalario de Salamanca, Salamanca, Spain.
Eva María VillarónDepartment of Hematology, Complejo Hospitalario de Salamanca, Salamanca, Spain.
Juan Ramón Valentí-NinDepartment of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, Pamplona, Spain.
Felipe PrósperCell Therapy Area, Clínica Universidad de Navarra, Pamplona, Spain. fprosper@unav.es.
Clinica Universidad de Navarra · ESComplejo Hospitalario de Salamanca · ESNavarre Institute of Health Research · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMesenchymal 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 × 10

resultsNo 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.

conclusionsSingle 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.

Indexed as

Mesenchymal Stem Cell TransplantationAgedFemaleFollow-Up StudiesHumansHyaluronic AcidInjections, Intra-ArticularMaleMesenchymal Stem CellsMiddle AgedOsteoarthritis, KneePainTransplantation, AutologousVisual Analog ScaleHyaluronic AcidIntraarticular injectionKnee osteoarthritisMesenchymal stem cells

Identifiers

PMID30064455
PMCPMC6069715
OpenAlexW2885408945

What OpenQuestion holds

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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.