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Decision Of 11 July 2014 Authorizing Research Protocol On The Human Embryonic Stem Cells In Accordance With The Provisions Of Article L. 2151-5 Of The Code Of Public Health

Original Language Title: Décision du 11 juillet 2014 portant autorisation de protocole de recherche sur les cellules souches embryonnaires humaines en application des dispositions de l'article L. 2151-5 du code de la santé publique

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JORF n°0189 of 17 August 2014 page 13671
text No. 10



Decision of 11 July 2014 authorizing a research protocol on human embryonic stem cells pursuant to the provisions of Article L. 2151-5 of the Public Health Code

NOR: AFSB1400133S ELI: https://www.legifrance.gouv.fr/eli/decision/2014/7/11/AFSB1400133S/jo/texte


Acting Director General of the Biomedicine Agency,
Vu le Public Health Codearticles L. 2151-5, R. 2141-17 to R. 2141-23, and R. 2151-1 to R. 2151-12;
Vu la Act No. 2013-715 of 6 August 2013 to amend the Act No. 2011-814 of 7 July 2011 relating to bioethics by authorizing under certain conditions research on embryo and embryonic stem cells;
Considering the Order of the Minister of Social Affairs and Health of June 17, 2014 appointing the Acting Director General of the Biomedicine Agency effective July 4, 2014;
In view of the decision of 17 September 2013 setting the application file model for the authorizations referred to in theArticle R. 2151-6 of the Public Health Code ;
Having regard to the advice issued by the Guidance Board of the Biomedicine Agency on June 26, 2014;
Considering the application submitted on March 31, 2014 by the National Institute of Health and Medical Research (UMR 1064) for the purpose of obtaining an authorization for a research protocol on human embryonic stem cells;
Considering the additional information provided by the applicant;
Considering the report of the inspection mission of the Biomedicine Agency dated 19 May 2014;
Based on expert reports dated 6 and 28 May 2014,


Considering that liver transplants appear in certain chronic or acute pathologies as the only therapeutic that can be considered (herited liver diseases, fulminating hepatocytes...); that, in a context of liver shortages from deceased donors, transplantation of allogenic primary hepatocytes also faces the scarcity of organs and difficulties associated with amplification
Considering that the purpose of the application is, in a translational preclinical approach, to test and use human embryonic stem cells as a source of quality hepatocytes, available in sufficient quantity and developed under GMP conditions ("Good Manufacturing Practices", equivalent of the French "Good Manufacturing Practices" (BPF) required to use a cell therapy product in patients; to obtain, among other things, the restoration of at least 5% to 10% of the activity of the deficient enzyme in metabolic pathologies in order to obtain a clinical improvement from 10% to 30% of the liver mass in order to temporarily support the regeneration of the endogenous liver in fulminant hepatitis;
Considering that the team of Mr. Tuan Huy Nguyen wishes to validate the in vitro efficacy of the ability to differentiate human embryonic stem cells from GMP-derived hepatocytes, in particular through the selection of lines derived under these conditions and used in other preclinical projects (RC-9, I6 and ESI-017) based on the protocols developed in the context of
That it is therefore a research protocol in a medical purpose;
Considering that, in the state of scientific knowledge, it cannot be carried out without resort to human embryonic stem cells; that the expected result cannot be obtained by other means, in particular by the exclusive use of other stem cells; that the very objective of the research envisaged explains the need to use human embryonic stem cells to the extent that it is intended to obtain transplantable hepatocytes and to date there is no lineage of induced pluripotent stem cells established in GMP condition; that the use of CSEH appears in this indispensable project in order to allow a rapid progression of the therapeutic strategies envisaged; It should be noted that research on PSIs and their use in therapeutic strategies are conducted in parallel in the European network to which Mr.Tuan Huy Nguyen's team collaborates, but that, in the opinion of the scientific community, IPS GMP lines allowing a clinical passage will not be available for several years;
Considering, therefore, that the applicant provides sufficient elements concerning the scientific relevance of the research project, on the one hand, and its conditions of implementation under ethical principles, on the other hand; that it justifies in particular that the project will be carried out in accordance with the ethical principles relating to research on embryo and human embryonic stem cells and that these cells have been obtained in accordance with the fundamental principles provided to human embryos Articles 16 to 16-8 of the Civil Code, with the prior consent of the reproductive couple and without any payment, in any form, being allocated to them; that the titles, diplomas, experience and scientific work provided in support of the application allow to ensure the skills of the research officer and the members of the research team in this regard;
Considering that premises, materials, equipment, processes and techniques are adapted to the proposed research activity,


Decides:

Article 1


The National Institute of Health and Medical Research (UMR 1064) is authorized to implement, under the conditions described in the application for authorization, the research protocol on human embryonic stem cells whose purpose is to study cell therapy of liver diseases with hepatocytes generated from human embryonic stem cells of the GMP grade. This research is under the responsibility of Mr. Tuan Huy Nguyen.

Article 2 Learn more about this article...


This authorization is granted for a period of four years. It may be suspended at any time for a maximum of three months, in the event of a violation of the legislative or regulatory provisions, by the Director General of the Biomedicine Agency. Authorization may also be withdrawn, in accordance with the terms and conditions set out in the provisions of Public Health Code.

Article 3


Any changes to the elements in the application for authorization must be made available to the Director General of the Biomedicine Agency.

Article 4


The Assistant Director General for Resources of the Biomedicine Agency is responsible for the execution of this decision, which will be published in the Official Journal of the French Republic.


Done on 11 July 2014.


For the Acting Director General:

The medical and scientific director,

K. Laouabdia-Sellami


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