Key Benefits:
Director General of the Biomedicine Agency,
Vu le Public Health Codearticles L. 2151-5 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 ;
Having regard to the advice issued by the Guidance Board of the Biomedicine Agency on October 15, 2015;
Considering the application submitted on March 31, 2015 by the National Institute of Health and Medical Research (Unit UMR 1064) for the purpose of obtaining an authorization for a research protocol on embryo and human embryonic stem cells;
Considering the additional information provided by the applicant;
Considering the report of the inspection mission of the Biomedicine Agency dated 2 June 2015;
Considering the expert reports dated 16 and 20 May 2015;
Considering that the project concerns the study of the quality of the pluripotence of human embryonic stem cells and the modulation of the degree of pluripotence through the conditions of culture, using lines of human embryonic stem cells, on the one hand, and cells directly taken from the embryo at the stage of morula or blastocyst, on the other hand; that it is in direct connection with the results obtained as part of a previous authorization for a research protocol on embryo and human embryonic stem cells issued by the Agency of Biomedicine to the team of Laurent David on April 24, 2014 and having for the purpose the study of the determinants of pluripotence during pre-gastric human development; that it is part of a global project of reprogramming and derivation of human embryonic stem cells (CSEh) in naive cells under conditions to keep the state of pluripotence, characteristic of the embryo;
Considering that the notion of pluripotence is eminently variable; that the tests in man to assess its quality and extent are very limited; that the pluripotence of embryonic stem cells is not equivalent to that of human embryonic stem cells as the pluripotence of the first is close to that comparable to the pluripotence of cells of an early embryo (reason for which
Considering that several teams are now trying to convert CSEh type "initiated" into naive cells, using molecules and modulating the conditions of culture; that, from a therapeutic point of view, it would be essential to have this type of cells, more genetically stable, with a wider potential and above all, that could be amplified by mass in unicellular suspension (when current CSEh do not survive under these conditions), essential condition for a wide-scale therapeutic application;
Considering that the objective of Laurent David is to obtain lines of CSEh that have retained, to the extent possible, the properties of the pluripotent cells of the embryonic button, either by deriving new lines of CSEh from embryos or by attempting to reprogram/convert CSEh "initiated" into "nave" cells; that it has in this context a database from the characterization of the molecular markers of the embryonic button, acquired during the progression of the research protocol authorized on April 24, 2014 that analyzes the transcriptome (all of the NNAs reflecting the genes expressed, sequenced by high-speed techniques) of individual cells of human embryos at various stages; evidence that several molecules and factors of growth
Considering that the demand is part of a medical purpose whose therapeutic objective is clearly expressed by the team; that the knowledge that will result from this project can have an impact on the regenerative medicine (choice of the therapeutic cells according to their potential and quality), on the one hand, and on the conditions of culture of the embryos obtained by in vitro fertilization, on the other hand, (in order to preserve at best the embryonic potential)
Considering that in the state of scientific knowledge, it cannot be carried out without using 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, given the significant differences between embryos and human stem cells and rodents, on the molecular and functional levels, there is no alternative to the use of human embryos; that the comparison of human embryonic stem cells and iPS cells being the object of the protocol itself, the use of CSEh appears indispensable;
Considering, therefore, that the applicant provides sufficient elements regarding the scientific relevance of the research project on the one hand, and its conditions of implementation under the ethical principles on the other; that it justifies in particular that the project will be conducted in accordance with the ethical principles relating to the embryo research and human embryonic stem cells, and that these cells have been obtained in compliance with the legislative and regulatory provisions; on the occasion of this application for import authorization, compliance with the requirements of the Articles 16 to 16-8 of the Civil Code and those relating to information and the collection of the consent of couples have been verified and the application for authorization resubmits all documents to ensure compliance with the legislative and regulatory conditions; that both lines are also registered in the NIH registry, ensuring respect for the fundamental ethical principles of donor consent, free donation and anonymity for imported human embryonic stem cells;
Considering that the titles, diplomas, experience and scientific work provided in support of the application help ensure the skills of the research manager and the team members in this field; that the team is important and well structured, and presents the capabilities required to carry out the program; that it has been exploring this area of research for many years; that Laurent David, through his training and experience, provides all the guarantees to ensure the success of this research program; that he is responsible for the IPS derivation platform in Nantes and lecturer at universities - hospital practitioner (MCU-PH) ; that he has benefited from excellent training in Canada by developing a project on the molecular understanding of the reprogramming stages and that he has a perfect knowledge of the regulation of the pluripotence, quite adapted to the project he wishes to develop, and a good knowledge applied to the genome
Considering that the structure is permanent and the team internationally recognized for its work; that it benefits from the commitment of the Director General of the University Hospital of Nantes;
Considering that the premises, materials, equipment, processes and techniques are adapted to the proposed research activity; that this research will be carried out in conditions that guarantee the safety of persons engaged in a professional activity on the site, respect for the applicable provisions in the field of environmental protection, respect for the sanitary security rules as well as the safety, quality and traceability of embryos and embryonic cells; that the material conditions of security, conservation,
Decides:
The National Institute of Health and Medical Research (Unit UMR 1064) is authorized to implement, under the conditions described in the application file, the research protocol on embryo and human embryonic stem cells with the purpose of deriving new types of human embryonic stem cells and comparing their metabolism with human embryonic stem cells WA-09 and WA-09 and WA-09 This research is under the responsibility of Mr. Laurent David.
This authorization is granted for a period of five 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 November 2, 2015.
A. Courts
