EUROpean clinical validation of a new ex vivo eXpanded stem cell theraPy for cArdiac regeNeration after acute myocarDial infarction: EUROXPAND

Informations projet

EuroXpand

N° de convention de subvention: 806595

DOI

10.3030/806595

Projet clôturé

Date de signature de la CE 11 Avril 2018

Date de début 1 Mai 2018

Date de fin 31 Decembre 2023

Financé au titre de

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

Coût total

€ 5 000 000,00

Contribution de l’UE

€ 5 000 000,00

Coordonné par

CELLPROTHERA
France

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Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Documents, reports (5)

Scientific publication(s) in renowned journals

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
Communication material (brochures, web…)

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

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

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

Peer reviewed articles (5)

Industrialized GMP Production of CD34+ Cells (ProtheraCytes®) at Clinical Scale for Treatment of Ischemic Cardiac Diseases Is Feasible and Safe

Auteurs: Philippe Hénon, Marc Kowalczyk, Anne Aries, Christine Vignon, Guillaume Trébuchet, Rachid Lahlil
Publié dans: Stem Cell Reviews and Reports, Numéro 18, 2022, Page(s) 1614-1626, ISSN 2629-3269
Éditeur: Springer
DOI: 10.1007/s12015-022-10373-5

Development of a potency assay for CD34+ cell-based therapy

Auteurs: Anne Aries, Christine Vignon, Céline Zanetti, Aurélien Goubaud, Arthur Cormier, Anne Diederichs, Rachid Lahlil, Philippe Hénon, Ibon Garitaonandia
Publié dans: Scientific Reports, Numéro 13, 2023, ISSN 2045-2322
Éditeur: Nature Publishing Group
DOI: 10.1038/s41598-023-47079-8

Design and Validation of an Automated Process for the Expansion of Peripheral Blood-Derived CD34+ Cells for Clinical Use After Myocardial Infarction

Auteurs: 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
Publié dans: Stem Cells Translational Medicine, Numéro 8, 2023, Page(s) 822-832, ISSN 2157-6564
Éditeur: AlphaMed Press
DOI: 10.1002/sctm.17-0277

Probing Multiple Transplant Delivery Routes of CD+34 Stem Cells for Promoting Behavioral and Histological Benefits in Experimental Ischemic Stroke

Auteurs: Jea-Young Lee, Justin Cho, Francesco D’Egidio, Christine Vignon, Hendrik Streefkerk, Matthieu de Kalbermatten, Ibon Garitaonandia, Cesar V Borlongan
Publié dans: Stem Cells Translational Medicine, Numéro 13, 2024, Page(s) 177-190, ISSN 2157-6564
Éditeur: AlphaMed Press
DOI: 10.1093/stcltm/szad081

Evaluation of expanded peripheral blood derived CD34+ cells for the treatment of moderate knee osteoarthritis

Auteurs: Christine Vignon, Morgane Hilpert, Karine Toupet, Aurélien Goubaud, Danièle Noël, Matthieu de Kalbermatten, Philippe Hénon, Christian Jorgensen, Andrea Barbero, Ibon Garitaonandia
Publié dans: Frontiers in Bioengineering and Biotechnology, Numéro 11, 2023, ISSN 2296-4185
Éditeur: Frontiers Media SA
DOI: 10.3389/fbioe.2023.1150522

Non-peer reviewed articles (1)

Regenerative Medicine for Cardiovascular Disease: Characterization and Clinical Success.

Auteurs: Garitaonandia I
Publié dans: Bioprocess International, 2024, Page(s) Pages 24-29, ISSN 1542-6319
Éditeur: BioProcess International

Book chapters (1)

CD34+ Stem Cells and Regenerative Medicine

Auteurs: Philippe Hénon, Rachid Lahlil
Publié dans: Stem Cells, 2023, Page(s) 21-34
Éditeur: Springer International Publishing
DOI: 10.1007/978-3-030-77052-5_2