Evidence map›Paper›PMID 31842921›Full record

ArticleJournal of orthopaedic surgery and research2019

Autologous bone marrow expanded mesenchymal stem cells in patellar tendinopathy: protocol for a phase I/II, single-centre, randomized with active control PRP, double-blinded clinical trial.

Gil Rodas, Robert Soler, Ramón Balius, Xavier Alomar, Xavier Peirau, Mercedes Alberca, Ana Sánchez, Javier García Sancho, Clementina Rodellar, Antonio Romero and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of orthopaedic surgery and research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03454737 (Treatment of Refractory Patellar Tendinopathy With Mesenquimal Trunk Cells. Comparative Study With PRP.), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 14% 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.

NCT03454737 naunknown statusnot on this map

Treatment of Refractory Patellar Tendinopathy With Mesenquimal Trunk Cells. Comparative Study With PRP.

TypeinterventionalSponsorInstitut de Terapia Regenerativa TissularRan2017 to 2020Enrolled20ConditionsPatellar TendinopathyArmsmesenchymal stem cells, Pure platelet-rich plasma
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Cell therapies for chondral defects of the talus: a systematic review.Journal of orthopaedic surgery and research · 2022
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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

13 authors at 8 institutions in 3 countries.

Gil RodasMedical Department, Football Club Barcelona, C/Aristides Maillol, s/n 08028, Barcelona, Spain.
Robert SolerITRT Institut Terapia Regenerativa Tissular Centro Médico Teknon, C/Vilana 12. 08022, Barcelona, Spain.
Ramón BaliusConsell Català del'Esport, Unitat d'Esporti Salut Av Països Catalans, 40-48, 08950, Esplugues, Spain.
Xavier AlomarDiagnóstico por la Imagen, Clínica Creu Blanca, Passeig de la Reina Elisenda de Montcada, 17, 08034, Barcelona, Spain.
Xavier PeirauITRT Institut Terapia Regenerativa Tissular Centro Médico Teknon, C/Vilana 12. 08022, Barcelona, Spain.
Mercedes AlbercaInstituto de Biología y Genética Molecular (IBGM), Universidad Valladolid y CSIC Edificio IBGM, C/ Sanz y Forés, s/n, 47003, Valladolid, Spain.
Ana SánchezInstituto de Biología y Genética Molecular (IBGM), Universidad Valladolid y CSIC Edificio IBGM, C/ Sanz y Forés, s/n, 47003, Valladolid, Spain.
Javier García SanchoInstituto de Biología y Genética Molecular (IBGM), Universidad Valladolid y CSIC Edificio IBGM, C/ Sanz y Forés, s/n, 47003, Valladolid, Spain.
Clementina RodellarLAGENBIO, Facultad de Veterinaria, Lab. Genética Bioquímica. Facultad de Veterinaria, Universidad de Zaragoza, C/Miguel Servet 177, 50013, Zaragoza, Spain.
Antonio RomeroLAGENBIO, Facultad de Veterinaria, Lab. Genética Bioquímica. Facultad de Veterinaria, Universidad de Zaragoza, C/Miguel Servet 177, 50013, Zaragoza, Spain.
Lorenzo MasciInstitute of Sport Exercise and Health, London, UK.
Lluís OrozcoITRT Institut Terapia Regenerativa Tissular Centro Médico Teknon, C/Vilana 12. 08022, Barcelona, Spain.
Nicola MaffulliDepartment of Musculoskeletal Disorders, University of Salerno School of Medicine, Surgery and Dentistry, Salerno, Italy. n.maffulli@qmul.ac.uk.ORCID http://orcid.org/0000-0002-5327-3702
Hospital Quirón Teknon · ESInstituto de Biomedicina y Genética Molecular de Valladolid · ESUniversidad de Zaragoza · ESClínica Girona · ESEnglish Institute of Sport · GBFC Barcelona · ESHospital Sant Joan de Déu Barcelona · ESUniversity of Salerno · IT

Funding

Institutde Terapia Regenerativa Tissular, Centro Medico Teknon ITRT.2018.23-B/CT
6 · The paper itself

Abstract

introductionPatellar tendon overuse injuries are common in athletes. Imaging may show a change in tissue structure with tendon thickening and disruption of the intratendinous substance. We wish to test the hypothesis that both autologous bone marrow expanded mesenchymal stem cells and autologous leukocyte-poor platelet-rich plasma (LP-PRP) implanted into the area of the disrupted tendinopathic patellar tendon will restore function, but tendon regeneration tissue will only be observed in the subjects treated with autologous bone marrow expanded mesenchymal stem cells. METHODS AND ANALYSIS: This is a single-centre, pilot phase I/II, double-blinded clinical trial with randomisation with active control. Twenty patients with a diagnosis of patellar tendinopathy with imaging changes (tendon thickening and disruption of the intratendinous substance at the proximal portion of the patellar tendon) will be randomised in a 1:1 ratio to receive a local injection of either bone-marrow autologous mesenchymal stem cells (MSC), isolated and cultured under GMP at The Institute of Biology and Molecular Genetics (IBGM) (Spain) or P-PRP. The study will have two aims: first, to ascertain whether a clinically relevant improvement after 3, 6 and 12 months according to the visual analogue scale (VAS), Victorian Institute of Sport Assessment for patellar tendons (VISA-P) and dynamometry scales (DYN) will be achieved; and second, to ascertain whether the proposed intervention will restore tendon structure as determined by ultrasonography (US), Doppler ultrasonography (DUS), and innovative MRI and ultrasound techniques: Magnetic Resonance T2 FAT SAT (UTE, Ultrashort Echo TE) sequence and Ultrasound Tissue Characterization (UTC). Patients who are randomised to the P-PRP treatment group but do not achieve a satisfactory primary endpoint after 6 months will be offered treatment with MSC.

trial registrationNCT03454737.

Indexed as

Patellar LigamentAdolescentAdultClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDouble-Blind MethodHumansMagnetic Resonance ImagingMaleMesenchymal Stem CellsMesenchymal Stem Cell TransplantationMiddle AgedPain MeasurementPatient SelectionPilot ProjectsRandomized Controlled Trials as TopicTendinopathy; Mesenchymal stem cells; Platelet-rich plasma

Identifiers

PMID31842921
PMCPMC6916077
OpenAlexW2994878906

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.