Key Benefits:
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;
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 ;
Considering the application submitted on October 31, 2013 by the National Institute of Health and Medical Research (U1064, Nantes University Hospital Centre) for the purpose of obtaining a protocol of research on the embryo;
Considering the additional information provided by the applicant;
Considering the report of the inspection mission of the Biomedicine Agency dated 28 January 2014;
Considering the expert reports of 15 and 16 December 2013;
Having regard to the advice issued by the Guidance Board of the Biomedicine Agency on April 3, 2014;
Considering that the project of Mr. Laurent David is based on a relatively recent concept in the human being, according to which there would not be only one type of pluripotent cells; that studies in the mice have already identified at least three types of pluripotent cells derived from embryos at different stages (cells of embryonic strata "naves", "opened" and that, compared to human embryonic stem cells, embryonic stem cells "naves" are more genetically stable, self-renewal more actively and can easily be dissociated enzymatically or genetically modified; that these considerations are of importance in a context of medical application; that it would appear that these characteristics are not due to the species (souris
Considering that genetic analyses of human embryos have already been carried out but have only been able to collect very unrecognized information as the analysis focused only on very heterogeneous cell populations with a few cells or ten cells; that only a single cell analysis can provide an answer to the questions raised and a better knowledge of human embryonic stem cells; that it is now possible to analyze in individual, and high-speed cells, the transcriptome (all RNAs), the proteome (all proteins) or the epigenome (all epigenetic changes), allowing to analyze the heterogeneity of a population so far considered homogeneous, and to discover the individual variations of certain cell processes;
Considering that Mr. Laurent David's request, in this context, is intended to carry out the high-speed ARN sequencing analysis of approximately 1,000 unique cells from human embryos at three stages of development (8 cells, morula and blastocyst), very high number, ensuring the scientific quality of the study and rigorous statistical analysis; then validate, by immunofluorescence, the presence or absence of proteins corresponding to the most interesting genes that have been identified in order to establish the functional meaning of these genes (especially their role in embryo morphology); and, finally, to study the development of embryos that will be used as part of research in an embryoscope, in order to establish a correlation between the morphology of the embryo and the expression of these genes;
Considering that the proposed project will thus collect valuable information on the existence of a signature of potentially important genes to ensure a pluripotent state of type embryonic stem cells murine, to improve the knowledge of the cellular pathways essential to an effective early embryo development and to propose markers of the quality of embryos in order to ultimately improve the conditions of embryo culture and the success rate of in vitro fertilizations;
That it is therefore a research protocol in a medical purpose;
Considering that, in the state of scientific knowledge, research cannot be conducted without resorting to human embryos or human embryonic stem cells; that the use of human embryos appears indispensable because of the inadequacy of animal models of embryonic stem cells with human embryonic stem cells; that the team of Laurent David will, in advance, optimize its experimental approach to bovine embryos;
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 Articles 16 to 16-8 of the Civil Code, and with the prior consent of the proprietor couple, and without any payment whatsoever form has been 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 members of the team in this matter; that Mr. Laurent David is responsible for the IPS derivation platform at the University Hospital in Nantes; that he has spent several years in Canada where he has carried out particularly interesting work on the reprogramming process in the context of the development of the iPS, works published in prestigious journals; that he has a great knowledge of the regulation of the important pluripotence and techniques adapted to the analysis of the university genome;
Considering that premises, equipment, equipment, processes and techniques are adapted to the proposed research project,
Decides:
The National Institute of Health and Medical Research (U1064) is authorized to implement, under the conditions described in the application for authorization, the research protocol on embryo and human embryonic stem cells with the purpose of studying the determinants of pluripotence in pre-gastric human development. This research is under the responsibility of Mr. Laurent David.
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.
Any changes to the elements in the application for authorization must be made available to the Director General of the Biomedicine Agency.
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 24 April 2014.
E. Prada-Bordenave
