CORDIS provides links to public deliverables and publications of HORIZON projects.
Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .
Deliverables
To achieve interventional cardiologists’ adhesion, scientific communication constitutes excellent proofs demonstrating efficacy, safety and relevance of CellProthera’s technology. Future publications in international peer-reviewed medical journals (New England Journal of Medicine, Nature, Circulation, British Journal of Cardiology…) will present the following:- Biological similarity of ex vivo expanded CD34+ cells versus peripheral blood CD34+ cells (see section0),- Safety and efficacy results of phase I/IIb underway,
Press Release - Project kick-off (opens in new window)Communication material (brochures, web…) (opens in new window)
To allow a wide dissemination of the presentation of EUROXPAND project, communication material (brochures, web…) will be realised.
Regulatory approvals - Phase III trial, approval of the protocol (opens in new window)To conduct a clinical study, regulatory approvals are mandatory in each country where the trial is performed. In France, regulatory requirements are composed of ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé) approval, which validate the scientific interest of the study and ethic acceptability, and of CPP (Comité de Protection des Personnes) approval, which analyses patient protection (de-identifying individual data…) and compliance to the legislation. In other countries, competent authorities must validate the trial: MHRA (Medicines and Healthcare Regulatory Administration) for the UK, URPL (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products) for Poland, SULK (State Institute for Drug Control) for Czech Republic, Infarmed (National Authority of Medicines and Health Products) in Portugal, and BFARM (Federal Institute for Drugs and Medical Devices) in Germany. For these countries, ethics committees are either centralised for the country in one entity, either localised in each investigators centres (hospitals).
Regulatory approvals - Early Access in France (opens in new window)An approval will be requested to benefit from the Early Access pathway enforced in France in July 2021, allowing Cellprothera to sell its therapy on the market.This decision is taken by 2 French health authorities, ANSM and HAS, based on given criteria (lack of appropriate treatment, innovative therapy...), bearing in mind that the own selling price will be set by the company and covered by the national social security.Phase II trial needs to be completed before requesting this Early Access.
Publications
Author(s):
Philippe Hénon, Marc Kowalczyk, Anne Aries, Christine Vignon, Guillaume Trébuchet, Rachid Lahlil
Published in:
Stem Cell Reviews and Reports, Issue 18, 2022, Page(s) 1614-1626, ISSN 2629-3269
Publisher:
Springer
DOI:
10.1007/s12015-022-10373-5
Author(s):
Anne Aries, Christine Vignon, Céline Zanetti, Aurélien Goubaud, Arthur Cormier, Anne Diederichs, Rachid Lahlil, Philippe Hénon, Ibon Garitaonandia
Published in:
Scientific Reports, Issue 13, 2023, ISSN 2045-2322
Publisher:
Nature Publishing Group
DOI:
10.1038/s41598-023-47079-8
Author(s):
Claire Saucourt, Sandrine Vogt, Amandine Merlin, Christophe Valat, Anthony Criquet, Laurence Harmand, Brigitte Birebent, Hélène Rouard, Christian Himmelspach, Éric Jeandidier, Anne-Gaële Chartois-Leauté, Sophie Derenne, Laurence Koehl, Joe-Elie Salem, Jean-Sébastien Hulot, Céline Tancredi, Anne Aries, Sébastien Judé, Eric Martel, Serge Richard, Luc Douay, Philippe Hénon
Published in:
Stem Cells Translational Medicine, Issue 8, 2023, Page(s) 822-832, ISSN 2157-6564
Publisher:
AlphaMed Press
DOI:
10.1002/sctm.17-0277
Author(s):
Jea-Young Lee, Justin Cho, Francesco D’Egidio, Christine Vignon, Hendrik Streefkerk, Matthieu de Kalbermatten, Ibon Garitaonandia, Cesar V Borlongan
Published in:
Stem Cells Translational Medicine, Issue 13, 2024, Page(s) 177-190, ISSN 2157-6564
Publisher:
AlphaMed Press
DOI:
10.1093/stcltm/szad081
Author(s):
Christine Vignon, Morgane Hilpert, Karine Toupet, Aurélien Goubaud, Danièle Noël, Matthieu de Kalbermatten, Philippe Hénon, Christian Jorgensen, Andrea Barbero, Ibon Garitaonandia
Published in:
Frontiers in Bioengineering and Biotechnology, Issue 11, 2023, ISSN 2296-4185
Publisher:
Frontiers Media SA
DOI:
10.3389/fbioe.2023.1150522
Author(s):
Garitaonandia I
Published in:
Bioprocess International, 2024, Page(s) Pages 24-29, ISSN 1542-6319
Publisher:
BioProcess International
Author(s):
Philippe Hénon, Rachid Lahlil
Published in:
Stem Cells, 2023, Page(s) 21-34
Publisher:
Springer International Publishing
DOI:
10.1007/978-3-030-77052-5_2
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