• Image courtesy of Dr Kristen Brennand & Dr Fred H. Gage/ Salk Institute for Biological Studies

    human stem cells 2
  • Image courtesy of Dr Yichen Shi and Dr Rick Livesey/ Cambridge Stem Cell Institute

    human stem cells
About EUCelLEX

The European EUCelLEX Project consists in a full examination of the application of the European rules regarding cell banks together with current practices in respect of the therapeutic use of human cells in the different countries concerned. The purpose is to submit the data obtained to the European Commission for it to draw up legislative measures in line with medical advances in this field.
The EUCelLEX project has received funding from the European Union’s FP7 and is coordinated by Emmanuelle RIAL-SEBBAG (Inserm).

Home

News

An updated report from the Regenerative Medicine Expert Group (RMEG) on progress to support the growth of regenerative medicine in the UK.

This report:

  • provides recommendations for implementing a regenerative medicine delivery strategy
  • acknowledges and builds on existing initiatives
  • recommends further actions to support the adoption and spread of these innovative treatments in healthcare
  • describes plans that will put the UK at the forefront of the application of regenerative medicine

Full report is available here.

Website of the UK Department of Health.

The EUcelLex project is thrilled to announce the workshop: «Stem cells in translation: the governance of clinical promise in regenerative medicine» to be held in Paris, on 11th and 12th May, 2016.
The objective of this workshop is to analyze governance issues at the translational frontier of stem cell science.

More information here.

Ethical and legal implications of stem cell sources/procurement, and roadmaps from research to therapy.

     WS2 - photo Venue: Budapest, Central European University.

     Dates: 18-19 May, 2015.

     Organizers: CEU-CELAB (HU), Legal Pathways Bv. (NL).

     Poster

    Final Programme

    Article

The Commission has adopted two sets of rules for human tissues and cells to protect patients in the EU through ensuring high quality and safety standards.

  • The first sets out technical requirements that facilitate tracing of all tissues and cells from donor to recipient, and vice versa. This will happen through a so-called ‘Single European Code’ and Commission hosted IT-platform ensuring uniform labelling of all tissues and cells distributed in the EU. In the case of a safety alert, this label will ensure that all recipients who received material from the same donor can be traced and treated as needed. It will also allow for unused tissues or cells to be discarded.

Commission Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells

  • The second directive covers imports and sets out procedures for ensuring that tissues and cells imported from third countries meet the same safety and quality standards as those procured, processed and distributed in the EU. These implementing rules will ensure safety for EU recipients in need of these tissues and cells, no matter their origin.

Commission Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells 

The Council of Europe European Committee on Organ Transplantation (CD-P-TO) has elaborated a new guide, “Parent’s Guide to Umbilical cord blood banking”, to provide clear, accurate and balanced information about the use of cord blood in medical treatment and to guide parents through their blood storage options.

Download the guide “Parent’s Guide to Umbilical cord blood banking