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

Project Information

ORTHOUNION

Grant agreement ID: 733288

DOI 10.3030/733288

Project closed

EC signature date 12 December 2016

Start date 1 January 2017

End date 30 June 2022

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost € 5 999 150,87

EU contribution € 5 999 150,87

Coordinated by

UNIVERSIDAD AUTONOMA DE MADRID
Spain

Deliverables

Other (2)

Final list of publications, communications, press release and media coverage

Compilation of publications, communications, press release and media coverage Contributors: All

Implement ORTHOUNION project on the dedicated website and establish a secured collaborative platform

Collaborative plataform for ORTHOUNION project

Documents, reports (10)

Bone turnover markers as supplemental method to monitor healing of fracture non unions after cell therapy

Protocol and outcome analysis

Results and conclusions, ORTHOUNION clinical trial

Description and analysis of data according with the clinical protocol Contributors SERMAS 2 UULM 4 CHUT 7 IOR 8

Report on potency assay enabling the detection of highly osteogenic MSC preparation

Experimental protocols and results

Report on the results of the cost-effectiveness analysis and cost-utility analysis of BM MSC therapy in long bone union delay (both intra clinical trial length and extra clinical trial at longer time horizon)

Costeffectiveness and costutility outcome analysisContributors UULM 4 IOR 8 UAM 1

Intermediate list of publications, communications, press release and media coverage

Compilation of divulgation publications, communications, press release and media coverage

Report on a potential model for industrial production of BM-MSC for bone regeneration that would be adequate for wide access to patients in medical practice at an affordable cost.

Document suggesting a potential model for industrial production of BMMSC for bone regeneration that would be adequate for wide access to patients in medical practice at an affordable cost Contributors SERMAS 2 UULM 4 IOR 8 POLICLINICO 10UNIMORE 9

Report on the impact of MSCs on chemoattraction and differentiation of these cells by in vitro co-culture studies and by in vivo approaches in ectopic and orthotopic transplantation

Experimental protocols and results

Report on time course of biochemical markers of bone turnover in patients with long-bone non unions after treatment

Protocol and outcome analysis

Completed recruitment, ORTHOUNION clinical trial

Report including the real dates of patients recriutment per country Contributors SERMAS 2 UULM 4 CHUT 7 IOR 8

Report and publication of Consensus conference on non-unions treatment in Europe

Results of the consensus conference on nonunions treatment in Europe Contributors All

Websites, patent fillings, videos etc. (2)

Creation of a website

ORTHOUNION website

Strategic business plan for ATMPs in bone regeneration

Publications

Peer reviewed articles (16)

Frontiers in non-union research

Author(s): Enrique Gómez-Barrena, Norma G. Padilla-Eguiluz, Philippe Rosset
Published in: EFORT Open Reviews, Issue 5/10, 2020, Page(s) 574-583, ISSN 2396-7544
Publisher: EFORT
DOI: 10.1302/2058-5241.5.190062

Impact of HOXB7 overexpression on human adipose-derived mesenchymal progenitors

Author(s): Elisabetta Manuela Foppiani, Olivia Candini, Ilenia Mastrolia, Alba Murgia, Giulia Grisendi, Anna Valeria Samarelli, Giulia Boscaini, Lucrezia Pacchioni, Massimo Pinelli, Giorgio De Santis, Edwin M. Horwitz, Elena Veronesi, Massimo Dominici
Published in: Stem Cell Research & Therapy, Issue 10/1, 2019, ISSN 1757-6512
Publisher: BioMed Central
DOI: 10.1186/s13287-019-1200-6

CD90 Is Dispensable for White and Beige/Brown Adipocyte Differentiation

Author(s): Meike Dahlhaus, Julian Roos, Daniel Engel, Daniel Tews, Daniel Halbgebauer, Jan-Bernd Funcke, Sophie Kiener, Patrick J. Schuler, Johannes Döscher, Thomas K. Hoffmann, Julia Zinngrebe, Markus Rojewski, Hubert Schrezenmeier, Klaus-Michael Debatin, Martin Wabitsch, Pamela Fischer-Posovszky
Published in: International Journal of Molecular Sciences, Issue 21/21, 2020, Page(s) 7907, ISSN 1422-0067
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/ijms21217907

Validation of a long bone fracture non-union healing score after treatment with mesenchymal stromal cells combined to biomaterials

Author(s): Enrique Gómez-Barrena, Norma G. Padilla-Eguiluz, Eduardo García-Rey, Pablo Hernández-Esteban, José Cordero-Ampuero, Juan C. Rubio-Suárez
Published in: Injury, Issue 51, 2020, Page(s) S55-S62, ISSN 0020-1383
Publisher: Elsevier BV
DOI: 10.1016/j.injury.2020.02.030

Reconstruction of Large Skeletal Defects: Current Clinical Therapeutic Strategies and Future Directions Using 3D Printing

Author(s): Luciano Vidal, Carina Kampleitner, Meadhbh Á. Brennan, Alain Hoornaert, Pierre Layrolle
Published in: Frontiers in Bioengineering and Biotechnology, Issue 8, 2020, ISSN 2296-4185
Publisher: Creative Commons Attribution License
DOI: 10.3389/fbioe.2020.00061

Regeneration of segmental defects in metatarsus of sheep with vascularized and customized 3D-printed calcium phosphate scaffolds

Author(s): Luciano Vidal, Carina Kampleitner, Stéphanie Krissian, Meadhbh Á Brennan, Oskar Hoffmann, Yago Raymond, Yassine Maazouz, Maria-Pau Ginebra, Philippe Rosset, Pierre Layrolle
Published in: Scientific Reports, Issue 10/1, 2020, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-020-63742-w

Apoptotic mesenchymal stromal cells support osteoclastogenesis while inhibiting multinucleated giant cells formation in vitro

Author(s): Paul Humbert, Meadhbh Á. Brennan, Julien De Lima, Régis Brion, Annie Adrait, Céline Charrier, Bénédicte Brulin, Valérie Trichet, Yohann Couté, Frédéric Blanchard, Pierre Layrolle
Published in: Scientific Reports, Issue 11/1, 2021, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-021-91258-4

Challenges of running a GMP facility for regenerative medicine in a public hospital

Author(s): Mariele Viganò, Rosaria Giordano, Lorenza Lazzari
Published in: Regenerative Medicine, Issue 12/7, 2017, Page(s) 803-813, ISSN 1746-0751
Publisher: Future Medicine Ltd.
DOI: 10.2217/rme-2017-0051

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

Author(s): 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, Eduardo García-Rey, José Cordero-Ampuero, Javier Vaquero-Martin, Francisco Chana, Fernando Marco, Javier García-Coiradas, Pedro Caba-Dessoux, Pablo de la Cuadra, Philippe Hernigou, Ch
Published in: Stem Cells International, Issue 2018, 2018, Page(s) 1-13, ISSN 1687-966X
Publisher: Stem Cells International
DOI: 10.1155/2018/6025918

Bioactivity of Biphasic Calcium Phosphate Granules, the Control of a Needle-Like Apatite Layer Formation for Further Medical Device Developments

Author(s): Cyril d’Arros, Thierry Rouillon, Joelle Veziers, Olivier Malard, Pascal Borget, Guy Daculsi
Published in: Frontiers in Bioengineering and Biotechnology, Issue 7, 2020, ISSN 2296-4185
Publisher: Frontiers Media S.A.
DOI: 10.3389/fbioe.2019.00462

Inflammatory response of mesenchymal stromal cells after in vivo exposure with selected trauma-related factors and polytrauma serum

Author(s): Elisa Maria Amann, Alexander Groß, Markus Thomas Rojewski, Hans Armin Kestler, Miriam Kalbitz, Rolf Erwin Brenner, Markus Huber-Lang, Hubert Schrezenmeier
Published in: PLOS ONE, Issue 14/5, 2019, Page(s) e0216862, ISSN 1932-6203
Publisher: Public Library of Science
DOI: 10.1371/journal.pone.0216862

Challenges in Clinical Development of Mesenchymal Stromal/Stem Cells: Concise Review

Author(s): Ilenia Mastrolia, Elisabetta Manuela Foppiani, Alba Murgia, Olivia Candini, Anna Valeria Samarelli, Giulia Grisendi, Elena Veronesi, Edwin M. Horwitz, Massimo Dominici
Published in: STEM CELLS Translational Medicine, Issue 8/11, 2019, Page(s) 1135-1148, ISSN 2157-6564
Publisher: AlphaMed Press
DOI: 10.1002/sctm.19-0044

FOXP1 circular RNA sustains mesenchymal stem cell identity via microRNA inhibition

Author(s): Alessandro Cherubini, Mario Barilani, Riccardo L Rossi, Murtadhah M K Jalal, Francesco Rusconi, Giuseppe Buono, Enrico Ragni, Giovanna Cantarella, Hamish A R W Simpson, Bruno Péault, Lorenza Lazzari
Published in: Nucleic Acids Research, Issue Nucleic Acids Research, Volume 47, Issue 10, 04 June 2019, 2019, Page(s) 5325–5340, ISSN 0305-1048
Publisher: Oxford University Press
DOI: 10.1093/nar/gkz199

Immune Modulation by Transplanted Calcium Phosphate Biomaterials and Human Mesenchymal Stromal Cells in Bone Regeneration

Author(s): Paul Humbert, Meadhbh Á. Brennan, Noel Davison, Philippe Rosset, Valérie Trichet, Frédéric Blanchard, Pierre Layrolle
Published in: Frontiers in Immunology, Issue 10, 2019, ISSN 1664-3224
Publisher: Frontiers in Immunology
DOI: 10.3389/fimmu.2019.00663

Dissecting the Pharmacodynamics and Pharmacokinetics of MSCs to Overcome Limitations in Their Clinical Translation

Author(s): Michela Salvadori, Nicola Cesari, Alba Murgia, Paola Puccini, Benedetta Riccardi, Massimo Dominici
Published in: Molecular Therapy - Methods & Clinical Development, Issue 14, 2019, Page(s) 1-15, ISSN 2329-0501
Publisher: CellPress
DOI: 10.1016/j.omtm.2019.05.004

Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production

Author(s): Mariele Viganò, Silvia Budelli, Cristiana Lavazza, Tiziana Montemurro, Elisa Montelatici, Stefania de Cesare, Lorenza Lazzari, Anna Rosa Orlandi, Giovanna Lunghi, Rosaria Giordano
Published in: Stem Cells International, Issue 2018, 2018, Page(s) 1-16, ISSN 1687-966X
Publisher: Hindawi
DOI: 10.1155/2018/3038565