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 filed on March 31, 2015 by Clean Cells SAS for the purpose of obtaining an authorization for a human embryonic stem cell research protocol;
Considering the additional information provided by the applicant;
Considering the report of the inspection mission of the Biomedicine Agency dated 6 August 2015;
Considering the expert reports of 20 July and 21 September 2015;
Considering that Clean Cells is a commercial company with the status of a pharmaceutical establishment following an authorization issued by the National Agency for the Safety of Medicine and Health Products; that it is therefore authorized to produce innovative therapy drugs that must be prepared, in accordance with the regulations, in a pharmaceutical establishment; that the Clean Cells company has already been authorized to implement a research protocol on human embryonic stem cells, under an authorization issued by the Biomedicine Agency on May 25, 2012, as part of the security of the cells for another project of the Ichans laboratory
Considering that the objective of the application is the production of cells intended for a clinical trial of phase I/II (including the Public Hospital Assistance of Paris is the promoter) within the framework of the PACE (Pioneer Advanced Cell Therapy of the Epidermis) proposed by the I-Stem laboratory of Marc Peschanski;
Considering that the initial research protocol has been developed by INSEERM, within the I-Stem laboratory, under the responsibility of Gilles Lemaître, by virtue of an authorization issued by the Agency of Biomedicine on 17 December 2010, renewed on 11 February 2013, in collaboration with Brigitte Dreno, which belongs to the cellular and gene therapy unit of the university hospital of Nantes
Considering that this program is in clinical phase; that he now brings together, in addition to Gilles Lemaître's research team, two providers, CiTox Lab and Clean Cells, who are responsible for regulatory security and toxicology studies, and the clinical team (cellular and gene therapy unit);
Considering that Clean Cells will be responsible for providing the substitute ready to be transplanted;
Considering that the application is part of a medical purpose whose therapeutic objective is clearly expressed by the team;
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 in addition to the uncertainty regarding the meaning of specific genomic abnormalities described in the pluripotent stem cells induced (iPS) and the difficulty of obtaining a sturdy differencia to date there is no lineage of induced pluripotent stem cells established in GMP condition (Good manufacturing practices, equivalent to good French manufacturing practices required for the use of a cell therapy product in patients); therefore, there is no, unlike human embryonic stem cells, of clinical grade iPS lineage currently validated and available;
Considering that to the extent that the team's program is directed towards a clinical application, there are currently no alternative cellular product with comparable efficacy, and that it is therefore justified that this team pursues its program with CSEh, in order to achieve a rapid clinical trial in the interest of patients, whose orientation council recalls the extreme gravity of their disease; that a dozen clinical trials were observed in the patient's interest;
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 under the ethical principles on the other; that it justifies in particular that the project will be carried out 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; Articles 16 to 16-8 of the Civil Code and those relating to information and the collection of the consent of couples were verified and the application for authorization resubmits all documents to ensure compliance with legislative and regulatory conditions;
Considering that the titles, diplomas, experience and scientific work provided in support of the application will ensure the skills of the research manager and the team members in this field; that the protocol will be carried out in close collaboration with the I-Stem laboratory and the teams of Gilles Lemaître and Christine Baldeschi of the I-Stem laboratory;
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:
Clean Cells is authorized to implement, under the conditions described in the application for authorization, the human embryonic stem cell research protocol, with the purpose of producing an epidermal substitute by a pharmaceutical facility for a phase I/II clinical trial ( PASTE-ES trial). This research is under the responsibility of Marc MEICHENIN, Scientific Director of the research team.
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. 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
