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Opendata, web and dolomites

ORTHOUNION SIGNED

ORTHOpedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs

Total Cost €

0

EC-Contrib. €

0

Partnership

0

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Outcomes and
results

ORTHOUNION project word cloud

Explore the words cloud of the ORTHOUNION project. It provides you a very rough idea of what is the project "ORTHOUNION" about.

authorized public pave bone standard heal arm refinement efficacy human trials monitored atmp regeneration health technique unions therapy unite credibility disability patient lower submitted al oacute pain barrena autologous healing injuries rct rate designed 92 mez 74 benefit eric reborne explore autograft underreported requiring permit indicate national personalized evaluation secondary msc biological orthounion absence adequately 90 et gmp clinical gcp spontaneous union gold clinically dose orthopaedic versus transfer marrow fp7 expanded cell enhancement medicinal alternative rcts strategies fracture surgery multicentric powered routine inferiority manuscript medicin reported manufacturing 2016 monitoring confirmation countries confirmed suggests treatments innovative trial associates prospective quality biomaterial translation randomized economic competent medicine participating lowered instruments supportive capacity ecrin current regenerative

Project "ORTHOUNION" data sheet

The following table provides information about the project.

Coordinator	UNIVERSIDAD AUTONOMA DE MADRID Organization address address: CALLE EINSTEIN 3 CIUDAD UNIV CANTOBLANCO RECTORADO city: MADRID postcode: 28049 website: http://www.uam.es contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Spain [ES]
Project website	https://orthounion.eu/
Total cost	5˙999˙150 €
EC max contribution	5˙999˙150 € (100%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-SC1-2016-RTD
Funding Scheme	RIA
Starting year	2017
Duration (year-month-day)	from 2017-01-01 to 2021-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	UNIVERSIDAD AUTONOMA DE MADRID UNIVERSIDAD AUTONOMA DE MADRID Organization address address: CALLE EINSTEIN 3 CIUDAD UNIV CANTOBLANCO RECTORADO city: MADRID postcode: 28049 website: http://www.uam.es contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (MADRID)	coordinator	824˙210.00
2	SERVICIO MADRILENO DE SALUD SERVICIO MADRILENO DE SALUD Organization address address: PLAZA CARLOS TRIAS BERTRAN 7 city: MADRID postcode: 28020 website: http://cort.as/10Yf contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (MADRID)	participant	1˙352˙056.00
3	UNIVERSITAET ULM UNIVERSITAET ULM Organization address address: HELMHOLTZSTRASSE 16 city: ULM postcode: 89081 website: www.uni-ulm.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (ULM)	participant	998˙476.00
4	ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK Organization address address: 5 RUE WATT city: PARIS postcode: 75013 website: www.ecrin.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	573˙694.00
5	ISTITUTO ORTOPEDICO RIZZOLI ISTITUTO ORTOPEDICO RIZZOLI Organization address address: VIA DI BARBIANO 1/10 city: BOLOGNA postcode: 40136 website: www.ior.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (BOLOGNA)	participant	449˙923.00
6	FONDAZIONE IRCCS CA' GRANDA - OSPEDALE MAGGIORE POLICLINICO FONDAZIONE IRCCS CA' GRANDA - OSPEDALE MAGGIORE POLICLINICO Organization address address: VIA FRANCESCO SFORZA 28 city: MILANO postcode: 20122 website: www.policlinico.mi.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (MILANO)	participant	420˙950.00
7	ETABLISSEMENT FRANCAIS DU SANG ETABLISSEMENT FRANCAIS DU SANG Organization address address: AVENUE DU STADE DE FRANCE 20 city: LA PLAINE SAINT DENIS postcode: 93210 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (LA PLAINE SAINT DENIS)	participant	394˙743.00
8	UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA Organization address address: VIA UNIVERSITA 4 city: MODENA postcode: 41121 website: www.unimore.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (MODENA)	participant	293˙680.00
9	BIOMATLANTE BIOMATLANTE Organization address address: 5 RUE EDOUARD BELIN - ZA DES IV NATIONS city: VIGNEUX DE BRETAGNE postcode: 44360 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (VIGNEUX DE BRETAGNE)	participant	277˙062.00
10	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE Organization address address: RUE DE TOLBIAC 101 city: PARIS postcode: 75654 website: www.inserm.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	221˙230.00
11	CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS Organization address address: BOULEVARD TONELLE 2 city: TOURS CEDEX 9 postcode: 37044 website: www.chu-tours.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (TOURS CEDEX 9)	participant	193˙125.00

Map

Project objective

Current orthopaedic treatments permit spontaneous bone regeneration to unite and heal 90% bone injuries. Non-union associates pain and disability, often requiring biological enhancement. Regenerative medicine research suggests to the general public that alternative treatments based on advanced therapy medicinal products (ATMP) are already available. However, early clinical trials only explore its potential benefit. Underreported results and absence of early trial confirmation in adequately powered prospective randomized clinical trials (RCT) indicate that evidence is not available to transfer any technique into routine clinical application. This ORTHOUNION Project was developed from FP7-Project (REBORNE). Its results confirmed 92% bone healing rate (Gómez-Barrena et al, 2016 submitted manuscript) with an autologous ATMP of GMP expanded bone marrow derived human MSC in non-unions, where the reported bone healing rate after surgery with standard bone autograft is 74%. Any further development requires adequately powered prospective RCTs. This will be the main aim of ORTHOUNION: to assess clinically relevant efficacy of an autologous ATMP with GMP multicentric production in a well-designed, randomized, controlled, three-arm clinical trial under GCP, versus bone autograft, gold-standard in fracture non-unions. A non-inferiority analysis will evaluate if cell dose can be lowered. ATMP has been authorized by the National Competent Authorities of the participating countries in 3 previous trials (REBORNE) and will be monitored by ECRIN-ERIC to ensure quality and credibility of RCT results. Secondary aims include innovative strategies to increase manufacturing capacity and lower costs to pave translation into routine clinical treatments, biomaterial refinement to facilitate surgery, personalized medicine supportive instruments for patient selection and monitoring, and health economic evaluation. Results in this project may help define the future of bone regenerative medicin

Deliverables

List of deliverables.
Creation of a website	Websites, patent fillings, videos etc.	2020-02-25 15:01:21
Implement ORTHOUNION project on the dedicated website and establish a secured collaborative platform	Other	2020-02-25 15:01:21

Take a look to the deliverables list in detail: detailed list of ORTHOUNION deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2018	Enrique GÃ³mez-Barrena, Norma G. Padilla-Eguiluz, Cristina AvendaÃ±o-SolÃ¡, ConcepciÃ³n Payares-Herrera, Ana Velasco-Iglesias, Ferran Torres, Philippe Rosset, Florian Gebhard, Nicola Baldini, Juan C. Rubio-Suarez, Eduardo GarcÃa-Rey, JosÃ© Cordero-Ampuero, Javier Vaquero-Martin, Francisco Chana, Fernando Marco, Javier GarcÃa-Coiradas, Pedro Caba-Dessoux, Pablo de la Cuadra, Philippe Hernigou, Charles-Henri Flouzat-Lachaniette, FranÃ§ois Gouin, Didier Mainard, Jean Michel Laffosse, Miriam Kalbitz, Ingo Marzi, Norbert SÃ¼dkamp, Ulrich StÃ¶ckle, Gabriela Ciapetti, Davide Maria Donati, Luigi Zagra, Ugo Pazzaglia, Guido Zarattini, Rodolfo Capanna, Fabio Catani 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 published pages: 1-13, ISSN: 1687-966X, DOI: 10.1155/2018/6025918	Stem Cells International 2018	2020-02-25
2017	Mariele ViganÃ², Rosaria Giordano, Lorenza Lazzari Challenges of running a GMP facility for regenerative medicine in a public hospital published pages: 803-813, ISSN: 1746-0751, DOI: 10.2217/rme-2017-0051	Regenerative Medicine 12/7	2020-02-25

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The information about "ORTHOUNION" are provided by the European Opendata Portal: CORDIS opendata.

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