Evidence map›Paper›PMID 29535772›Full record

ArticleStem cells international2018

A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol.

Enrique Gómez-Barrena, Norma G Padilla-Eguiluz, Cristina Avendaño-Solá, Concepción Payares-Herrera, Ana Velasco-Iglesias, Ferran Torres, Philippe Rosset, Florian Gebhard, Nicola Baldini, Juan C Rubio-Suarez and 24 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Stem cells international, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03325504 (A Multi-centre, Open-label, Randomized, Comparative Clinical Trial of Two Doses of Bone Marrow Autologous MSC+ Biomaterial vs Iliac Crest Autologous Graft, for Bone Healing in Non-union After Long Bone Fractures), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 7% 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.

NCT03325504 phase3completednot on this map

A Multi-centre, Open-label, Randomized, Comparative Clinical Trial of Two Doses of Bone Marrow Autologous MSC+ Biomaterial vs Iliac Crest Autologous Graft, for Bone Healing in Non-union After Long Bone Fractures

TypeinterventionalSponsorUniversidad Autonoma de MadridRan2017 to 2023Enrolled46ConditionsNon Union FractureArmsCultured Mesenchymal Stem Cells, Autologous iliac crest graft
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

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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

34 authors at 20 institutions in 4 countries.

Enrique Gómez-BarrenaServicio de Cirugía Ortopédica y Traumatología, Hospital de Traumatología, Hospital La Paz, IdiPAZ, Universidad Autónoma de Madrid, P° Castellana 261, 28046 Madrid, Spain.ORCID 0000-0003-1065-6137
Norma G Padilla-EguiluzHospital Universitario La Paz, HTR Planta 1, Despacho Médico, Universidad Autónoma de Madrid, P° Castellana 261, 28046 Madrid, Spain.
Cristina Avendaño-SoláClinical Pharmacology Unit, Hospital Universitario Puerta de Hierro Majadahonda, Manuel de Falla 1, Majadahonda, 28222 Madrid, Spain.
Concepción Payares-HerreraClinical Pharmacology Unit, IIS Puerta de Hierro-Segovia de Arana, Hospital Universitario Puerta de Hierro Majadahonda, Manuel de Falla 1, Majadahonda, 28222 Madrid, Spain.
Ana Velasco-IglesiasIIS Puerta de Hierro-Segovia de Arana, SCRen, Manuel de Falla 1, Majadahonda, 28222 Madrid, Spain.
Ferran TorresHospital Clínic de Barcelona, Biostatistics Unit, IDIBAPS, Carrer de Villarroel 170, 08036 Barcelona, Spain.
Philippe RossetChirurgie Orthopédique et Traumatologique, Centre Hospitalier et Universitaire de Tours, Avenue de la République, 37170 Chambray Les Tours, France.
Florian GebhardDepartment of Orthopaedic Trauma, Ulm University Hospital, Albert-Einstein-Allee 23, 89081 Ulm, Germany.
Nicola BaldiniDipartimento di Scienze Biomediche e Neuromotorie, Alma Mater Studiorum-Università di Bologna, SSD Fisiopatologia Ortopedica e Medicina Rigenerativa, Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy.
Juan C Rubio-SuarezServicio de Cirugía Ortopédica y Traumatología, Hospital Universitario La Paz, P° Castellana 26, 28046 Madrid, Spain.
Eduardo García-ReyServicio de Cirugía Ortopédica y Traumatología, Hospital Universitario La Paz, P° Castellana 26, 28046 Madrid, Spain.
José Cordero-AmpueroServicio de Cirugía Ortopédica y Traumatología, Hospital Universitario La Princesa, Calle Diego de León 62, 28006 Madrid, Spain.
Javier Vaquero-MartinServicio de Cirugía Ortopédica y Traumatología, Hospital Universitario Gregorio Marañón, Calle del Dr. Esquerdo 46, 28007 Madrid, Spain.
Francisco ChanaServicio de Cirugía Ortopédica y Traumatología, Hospital Universitario Gregorio Marañón, Calle del Dr. Esquerdo 46, 28007 Madrid, Spain.
Fernando MarcoServicio de Cirugía Ortopédica y Traumatología, Hospital Clínico San Carlos, Calle del Prof. Martín Lagos, s/n, 28040 Madrid, Spain.
Javier García-CoiradasServicio de Cirugía Ortopédica y Traumatología, Hospital Clínico San Carlos, Calle del Prof. Martín Lagos, s/n, 28040 Madrid, Spain.
Pedro Caba-DessouxServicio de Cirugía Ortopédica y Traumatología, Hospital Universitario 12 de Octubre, Avenida de Córdoba, s/n, 28041 Madrid, Spain.
Pablo de la CuadraServicio de Cirugía Ortopédica y Traumatología, Hospital Universitario Puerta de Hierro Majadahonda, Calle Manuel de Falla 1, Majadahonda, 28222 Madrid, Spain.
Philippe HernigouDepartment of Orthopaedic Surgery, Hospital Henri Mondor, 51 Avenue du Maréchal de Lattre de Tassigny, 94010 Créteil Cedex, France.
Charles-Henri Flouzat-LachanietteDepartment of Orthopaedic Surgery, Hospital Henri Mondor, 51 Avenue du Maréchal de Lattre de Tassigny, 94010 Créteil Cedex, France.
François GouinDepartment of Orthopaedic Surgery, CHU Nantes, 1 Place Alexis-Ricordeau, 44093 Nantes Cedex 1, France.
Didier MainardDepartment of Orthopaedic Surgery, CHU Nancy, 5 rue du Morvan, 54500 Vandœuvre-lès-Nancy, France.
Jean Michel LaffosseDepartment of Orthopaedic Surgery, CHU Toulouse, 170 Avenue de Casselardit, 31059 Toulouse, France.
Miriam KalbitzDepartment of Orthopaedic Trauma, Ulm University Hospital, Albert-Einstein-Allee 23, 89081 Ulm, Germany.
Ingo MarziDepartment of Trauma, Hand and Reconstructive Surgery, Universitätsklinikum Frankfurt, Universitätsklinikum-Haus 1, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany.
Norbert SüdkampKlinikfür Orthopädie und Unfallchirurgie, Universitätsklinikum Freiburg, Hugstetter Str. 55, 79106 Freiburg im Breisgau, Germany.
Ulrich StöckleKlinikfür Unfall- und Wiederherstellungschirurgie, Universitätsklinikum Tübingen, Schnarrenbergstraße 95, 72076 Tübingen, Germany.
Gabriela CiapettiSSD Fisiopatologia Ortopedica e Medicina Rigenerativa, Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy.ORCID 0000-0001-6740-0357
Davide Maria DonatiClinica Ortopedica e Traumatologica III a Prevalente Indirizzo Oncologico, Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy.
Luigi ZagraChirugia dell'Anca 1, Istituto Ortopedico Galeazzi, Via Riccardo Galeazzi 4, 20161 Milano, Italy.
Ugo PazzagliaAzienda Spedali Civili di Brescia, Piazzale Spedali Civili 1, 25123 Brescia, Italy.
Guido ZarattiniAzienda Spedali Civili di Brescia, Piazzale Spedali Civili 1, 25123 Brescia, Italy.
Rodolfo CapannaII Clinica Universitaria Ortopedia e Traumatologia, Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 56126 Pisa, Italy.
Fabio CataniReparto di Ortopedia e Traumatologia, Azienda Ospedaliero-Universitaria di Modena, Largo del Pozzo 71, 41125 Modena, Italy.
Hospital Universitario La Paz · ESHospital Universitario Puerta de Hierro Majadahonda · ESIstituto Ortopedico Rizzoli · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITCentre Hospitalier Universitaire Henri-Mondor · FRHospital Clínico San Carlos · ESHospital General Universitario Gregorio Marañón · ESUniversity Hospital Ulm · DEAzienda Ospedaliera Universitaria Pisana · ITAzienda Ospedaliero-Universitaria di Modena · ITBG Klinik Tübingen · DECentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Universitaire de Nantes · FRCentre Hospitalier Universitaire de Toulouse · FRCentre Hospitalier Universitaire de Tours · FRGoethe University Frankfurt · DEHospital Clínic de Barcelona · ESHospital Universitario 12 De Octubre · ESHospital Universitario de La Princesa · ESIstituto Ortopedico Galeazzi · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ORTHOUNION is a multicentre, open, comparative, three-arm, randomized clinical trial (EudraCT number 2015-000431-32) to compare the efficacy, at one and two years, of autologous human bone marrow-derived expanded mesenchymal stromal cell (hBM-MSC) treatments versus iliac crest autograft (ICA) to enhance bone healing in patients with diaphyseal and/or metaphysodiaphyseal fracture (femur, tibia, and humerus) status of atrophic or oligotrophic nonunion (more than 9 months after the acute fracture, including recalcitrant cases after failed treatments). The primary objective is to determine if the treatment with hBM-MSCs combined with biomaterial is superior to ICA in obtaining bone healing. If confirmed, a secondary objective is set to determine if the dose of 100 × 10

Identifiers

PMID29535772
PMCPMC5842679
OpenAlexW2790917774

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.