The 4 phases of the EUCelLEX Project:
- Information gathering on the legal implementation of the directive on tissues and cells, with the focus on current European legislation and the regulations set forth at national level.
- Integration of this knowledge into a wider analytical context covering the entire field, focusing on stem cells and the cord blood banks.
- Make an in-depth analysis of the legislation, the literature, case law and the gathering of opinions on the various ethical aspects.
- Create tools for the participation of the professional people involved and the key players in the questions raised by the use of stem cells.
The project will deploy an innovative evidence-based “holistic” approach, scrutinizing the current and expected state of the art of the development of Stem cells applications (therapies or medicinal products) for compliance with the European regulatory framework. To that end, it will involve and engage the whole range of stakeholders from academia, the public and the private sector.
This project, launched on October 2013, will last 36 months and is structured in 7 workpackages (WP):
- WP1 – Management and Coordination
- WP2 – Stem cell sources and procurement
- WP3 – Stem Cell Use
- WP4 – Cord blood banks
- WP5 – Translational Research
- WP6 – Cells, ethics and societal innovation
- WP7 – Integration, synthesis and recommendations