Key Benefits:
Director General of the Biomedicine Agency,
Vu le Public Health Codearticles L. 2151-5, R. 2141-17 to R. 2141-23, R. 2151-1 and R. 2151-2 to 12;
Vu la Act No. 2011-814 of 7 July 2011including article 57;
Considering the decision of 10 February 2006 setting out the application file model for the authorizations referred to in theArticle R. 2151-6 of the Public Health Code ;
Considering the application submitted on March 31, 2012 by the National Institute of Health and Medical Research (U661) for the renewal of the human embryonic stem cell research protocol authorization issued on June 15, 2007;
Considering the report of the inspection mission dated 2 April 2012;
Having regard to expert reports dated 4 and 8 May 2012;
Considering the advice issued by the guidance board on 6 July 2012;
Considering that the research aims to understand the epigenetic mechanisms that accompany the process of cell senescence and their reversibility during the process of induced reprogramming; that the protocol aims to study two fundamental cell changes between senescent and pluripotence, the analysis of the origins of replication in these two states during cell division, on the one hand, and the analysis of the organization
That it is therefore a research that could allow major medical progress;
Considering that the expected result can not be obtained by other means, especially by the exclusive use of other stem cells; that research is an indispensable prerequisite for the potential use of pluripotent stem cells in regenerative medicine; that human embryonic stem cells, of natural pluripotence, are here used as referent and control in order to study the characteristics of the induced pluripotence of adult cells
Considering that a first authorization was granted in 2007 for a period of five years; that the team has progressed according to the planned schedule and has obtained important results that resulted in a publication in an international journal in 2011; that this application is in keeping with the previous protocol;
Considering, therefore, that the applicant provides sufficient information on the scientific relevance of the research project, on the one hand, and its conditions of implementation in relation to ethical principles and its interest in public health, on the other hand; that it justifies the need for research on embryos or human embryonic stem cells; that the titles, diplomas, experience and scientific work provided help to ensure the responsible competence of the members
Decides:
The National Institute of Health and Medical Research (U661) 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 the reprogramming of senescent cells towards pluripotence. This research is under the responsibility of Jean-Marc Lemaître.
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. The authorization may also be withdrawn, in accordance with the provisions of the articles of the 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 18 July 2012.
E. Prada-Bordenave
