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. 2011-814 of 7 July 2011including article 57;
In light of the decision of 12 April 2012 setting the application file model for the authorities referred to in theArticle R. 2151-6 of the Public Health Code ;
Considering the decision of the Director General of the Agency for Biomedicine of 12 March 2010 authorizing the National Institute for Health and Medical Research (U 846) to implement the research protocol on human embryonic stem cells with the purpose of identifying the genes involved in the control of self-renewal of human embryonic stem cells;
Considering the application submitted on 30 January 2013 by the National Institute of Health and Medical Research (U 846) for the purpose of obtaining the renewal of its research protocol authorization on human embryonic stem cells;
Considering the report of the inspection mission dated 16 April 2013;
Considering the expert reports of 10 and 11 April 2013;
Considering the advice issued by the Guidance Board on May 23, 2013;
Considering that the laboratory of Pierre Savatier is one of the only in France to explore the determinants of pluripotence on a fundamental plane, comparing the properties of embryonic stem cells derived from several species (souris, monkey, rabbit, man); that the criteria analyzed are both molecular (panel of the genes expressed, in particular) and functional (cellular cycle, resistance of cells to dissociation
Considering that murine embryonic stem cells are self-renewed in a state of so-called naive pluripotence (the cells from so-called early blastocysts are not engaged in a path of differentiation and are able to participate in post-natal chimera with great efficiency) by exploiting the signalling paths LIF and STAT3; that this state is characterized by a simple, stable self-renewal that this state is characterized by unstable self-renewal, high levels of apoptosis and differentiation, and greater genetic instability; that their culture also requires complex and costly environments, containing products of animal origin that may be contaminated;
Considering that the objective of the research is to understand the mechanisms regulating the self-renewal and the state of pluripotence of human embryonic stem cells and to apprehend the molecular mechanisms responsible for the divergence between the naive states and initiated of pluripotence; that this fundamental knowledge could significantly promote the use of these cells for therapeutic purposes, reproducible and controlled; that the improvement of the conditions of culture for a
That it is therefore a research that could allow major medical progress;
Considering that the expected result cannot be obtained by other means, including by the exclusive use of other stem cells; that in the current state of science many data show that the lines of iPS stem cells do not faithfully reproduce the phenotype of human embryonic stem cells; that the study of physiological mechanisms for regulating autorenewal and the development of strategies to improve quality justify the use of human embryonic stem cells, which remain the reference to study the cardinal properties of the pluripotence;
Considering that a first authorization was granted in 2005 for a period of five years and was first renewed in 2010 for three years; that the team progressed according to the planned schedule and achieved significant results; that it has developed, from a line of human embryonic stem cells derived in its laboratory (OSCAR), a line of inductible over-expression of agent STAT3, under hormone-dependent control (F-OSCAR-S3); that they have studied the ability to renew these cells under the action of the LIF, the regulation of the genes obtained from the STAT3 channel
Considering that this application is part of the continuity of the previous protocol; that the sum of the results obtained is original and important and requires additional validations in order to allow their publication; that the completion of this study justifies the request for renewal, which proposes to further deepen the knowledge of the underlying mechanisms to the conversion of human embryonic stem cells into improved cell derivatives; that it is now necessary to confirm the results previously obtained
Considering, therefore, that the applicant brings sufficient elements concerning the scientific relevance of the research project, on the one hand, and its conditions of implementation with regard to the ethical principles and its interest in public health, on the other hand; that it justifies the need to use research on embryos or human embryonic stem cells; that the titles, diplomas, experience and scientific works provided allow to ensure the responsible skills of the
Decides:
The National Institute of Health and Medical Research (U 846) is authorized to implement, under the conditions described in the application file, the research protocol on human embryonic stem cells with the purpose of identifying the genes involved in self-renewal control. This research is under the responsibility of Mr. Pierre Savatier.
This authorization is granted for a period of three 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 19 June 2013.
E. Prada-Bordenave
