The mission of the Cellular Therapy & Immunobiology Working Party is to understand and exploit the biological, including immunological, events occurring upon haematopoietic stem cell transplantation at large, and to implement modern cellular therapies based on cell and gene engineering approaches to improve transplantation outcomes.
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Cellular Therapy is an emerging medical science that is today facing a unique developmental phase, well documented by the outstanding and growing numbers of clinical trials. Such an exponential growth requires proper infrastructures, cell repositories, clinical registries, technical and regulatory guidelines for appropriate cell manipulation and validation of the innovative therapeutic approaches in multicentric clinical trials.
The CTIWP aims at fostering cellular therapy in Europe, through a continuous crosstalk between basic science findings, transplant immunobiology observations and implementation of cellular manufacturing approaches designed to answer unmet medical needs.
To this aim we will actively implement:
- Retrospective and multicentric prospective transplant immunobiology studies
- Retrospective and multicentric prospective clinical trials of cell/gene therapy
- A map of European Centers active in cell manipulation and cell therapy
- A dedicated registry for cellular products and clinical trials of cell and cell-based gene therapy.
These aims will be pursued through the activity of WP subcommittees and through an active collaboration with International and European Societies of Transplantation, Cell/Gene Therapy and with major investors in the field.
The LRAC and CTIWP have launched an open call for feedback and participation in workpackages (WP) - all EBMT Members as well as non members interested in CAR T therapies are invited to answer this open call until the September 1, 2019.
The EBMT registry has been qualified by EMA as a suitable platform for the collection of data for post-authorisation safety surveillance and efficacy studies.
EBMT requested qualification of the cellular therapy module of the EBMT Registry as suitable for performing pharmacoepidemiological studies for regulatory purposes, concerning CAR-T cell therapy for haematological malignancies.