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CICBT

CLINICAL INVESTIGATION CENTER for BIOTHERAPIES
SAINT-LOUIS SITE

The purpose of the Clinical Center of Investigation for Biotherapies (CIC-BT) created on the site of Saint-Louis is to propose to the various partners involved in biotherapy activities a federative structure for the integration and coordination of the projects of the scientific and medical community of the Northern hospitals (GHU Nord).

1. Why a CIC-BT on the site of Saint-Louis?

The Saint-Louis hospital is characterized by activities with a prevalent hematologic orientation. Patients suffering from hematologic diseases depend on the applicability of biotherapies: drugs resulting from genetic engineering or cell transplantations. The best example is the hematopoietic stem cell (HSC) transplantation which still represents today the main activity of cell therapy units. As a matter of fact, about 400 transplantations of autologous or allogenic HSC were made in 2005 starting from the products prepared in the cell therapy unit of the Saint-Louis site.

This activity is at the origin of the dynamics of this site in coordinating cellular and non cellular biotherapy projects, from research to production under good manufacturing practice conditions and to clinical trial settings. The activity of the CIC-BT Saint-Louis is clearly multi-disciplinary and relates non only to hematology but also to tissue repair and immunotherapy. Some important steps testify to this dynamics, especially the first hematologic reconstitution after cord blood transplant (New Engl J Med 1989 and 1997) and the first preparation of myoblasts for intra-myocardic injection (Lancet 2001). The identification of products or strategies of innovating biotherapies consequently led to patent registrations, publications and to the development of clinical trials relating to gene therapy, bone reconstitution or immunotherapy of malignant diseases (Nature Med 1999, Nature Biotech 2000, Science 2001, Nature Med 2003).

This development of biotherapies on the campus of Saint-Louis is performed within the context of biotherapy education. The education of doctoral school B2T concerns the cellular and molecular mechanisms involved in the research orientations in biotherapies of the site. The University diploma of Cell Therapy has been created in 1997 by the persons in charge of the biotherapies on the site and permits the education of a great number of cell therapy specialists at the national level. An annual seminar of the IUH is devoted to cell therapy. Within the framework of LMD reform, a dedicated EU was created in Master "Health" of the Saint-Louis/Lariboisière Faculty.

2. Means

The Saint-Louis CIC-BT is a federation of means set at the interface between upstream research units (especially those of the University Institute of Hematology, University of Paris VII), and downstream clinical services of the AP-HP hospitals (especially those of the GHU Nord). As a result to its certification, after the call to projects 2003 concerning the CIC for biotherapy (INSERM-DHOS), the Saint-Louis CIC-BT benefits from a joint credit endowment from INSERM, DHOS and AFM, in a multiannual programming over 4 years.

Apart from these specific means, the Saint Louis CIC-BT is functionally closely associated with the Department of Cell and Tissue Biotherapies of the Saint-Louis hospital (Dr. M. Benbunan) and its three components:

1) The Unit of cell therapy whose means were reinforced since June 2005 with the installation of new laboratory concerning the production sector (Dr. J. Larghéro) as well as the quality control sector (Dr. D. Réa), with the setting of a transfer structure;

2) The Unit of cell biology (Pr C. Chomienne) whose activities are centered on cellular handling with diagnosis purpose and/or therapeutic targeting, on the one hand, and determinations of cell, protein or gene markers, on the other hand;

3) The Human Tissue Bank (Dr. Mr. Jarraya). Are also associated to the functioning of the CIC-BT, on the one hand, the structures involved in the accompaniment of clinical research programs, in particular the Clinical Investigation Center (CIC )(Pr F. Calvo) and the unit of research in statistical methodology (Pr S. Chevret, INSERM U 717) and, on the other hand, the pharmacy (P. Faure), taking into account its expertise in the management of drugs and annex therapeutic products (ATP) and its role at the level of statutory vigilance.

3. Funtioning

The functions of coordinator and coordinator-assistant of the CIC-BT are filled respectively by Dr. M. Benbunan and Pr. C. Chomienne (INSERM U 718) who ensures the link with the University Institute of Hematology. The CIC-BT has a multidisciplinary scientific council composed of external experts and which will have an annual meeting to evaluate the CIC-BT activity and to give strategic opinions. A coordinating committee of the CIC-BT has been constituted, which meets approximately every six weeks since March 2005, and of which the scientific and practical functioning is ensured by Dr. C. Dosquet (Cell Therapy Unit).This committee has the role of following the evolution of the biotherapy projects and of contributing, from the pre-clinical stage, to the realization of the projects selecting for each project a steering committee. The person in charge for each steering committee coordinates the functioning of the various structures taking part in the trial and contributes to the constitution of the statutory files.

4. The biotherapy projects of the Saint-Louis CIC-BT in May 2006

The progression of the various programs from research to the clinic is determined thanks to a stage classification. Stage 1 corresponds to clinical trial in progress, stage 2 indicates the transfer towards the clinic and the constitution of the statutory files and stage 3 corresponds to the projects at the preclinic stage.

MSC = mesenchymal stem cell, HSC = hematopoietic stem cell, DGA = "direction générale des armées", GVHD = graft versus host disease, IV = intra-venous, AML = acute myeloblastic leukemia

Date of publication : mercredi 08 septembre