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

Projektinformationen

EuroXpand

ID Finanzhilfevereinbarung: 806595

DOI

10.3030/806595

Projekt abgeschlossen

EK-Unterschriftsdatum 11 April 2018

Startdatum 1 Mai 2018

Enddatum 31 Dezember 2023

Finanziert unter

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

Gesamtkosten

€ 5 000 000,00

EU-Beitrag

€ 5 000 000,00

Koordiniert durch

CELLPROTHERA
France

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Leistungen

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.

Veröffentlichungen

Peer reviewed articles (5)

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

Autoren: Philippe Hénon, Marc Kowalczyk, Anne Aries, Christine Vignon, Guillaume Trébuchet, Rachid Lahlil
Veröffentlicht in: Stem Cell Reviews and Reports, Ausgabe 18, 2022, Seite(n) 1614-1626, ISSN 2629-3269
Herausgeber: Springer
DOI: 10.1007/s12015-022-10373-5

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

Autoren: Anne Aries, Christine Vignon, Céline Zanetti, Aurélien Goubaud, Arthur Cormier, Anne Diederichs, Rachid Lahlil, Philippe Hénon, Ibon Garitaonandia
Veröffentlicht in: Scientific Reports, Ausgabe 13, 2023, ISSN 2045-2322
Herausgeber: 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

Autoren: 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
Veröffentlicht in: Stem Cells Translational Medicine, Ausgabe 8, 2023, Seite(n) 822-832, ISSN 2157-6564
Herausgeber: 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

Autoren: Jea-Young Lee, Justin Cho, Francesco D’Egidio, Christine Vignon, Hendrik Streefkerk, Matthieu de Kalbermatten, Ibon Garitaonandia, Cesar V Borlongan
Veröffentlicht in: Stem Cells Translational Medicine, Ausgabe 13, 2024, Seite(n) 177-190, ISSN 2157-6564
Herausgeber: AlphaMed Press
DOI: 10.1093/stcltm/szad081

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

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

Non-peer reviewed articles (1)

Regenerative Medicine for Cardiovascular Disease: Characterization and Clinical Success.

Autoren: Garitaonandia I
Veröffentlicht in: Bioprocess International, 2024, Seite(n) Pages 24-29, ISSN 1542-6319
Herausgeber: BioProcess International

Book chapters (1)

CD34+ Stem Cells and Regenerative Medicine

Autoren: Philippe Hénon, Rachid Lahlil
Veröffentlicht in: Stem Cells, 2023, Seite(n) 21-34
Herausgeber: Springer International Publishing
DOI: 10.1007/978-3-030-77052-5_2