• 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).

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Authors: Bayon Yves, Vertès Alain A., Ronfard Vincent, Culme-Seymour Emily, Mason Chris, Stroemer Paul, Najimi Mustapha, Sokal Etienne, Wilson Clayton, Barone Joe, Aras Rahul, and Chiesi Andrea.

Article in Tissue Engineering Part B: Reviews. November 2015, 21(6): 560-571. doi:10.1089/ten.teb.2015.0068.

Abstract: The TERMIS-Europe (EU) Industry committee intended to address the two main critical issues in the clinical/commercial translation of Advanced Therapeutic Medicine Products (ATMP): (1) entrepreneurial exploitation of breakthrough ideas and innovations, and (2) regulatory market approval. Since January 2012, more than 12,000 publications related to regenerative medicine and tissue engineering have been accepted for publications, reflecting the intense academic research activity in this field. The TERMIS-EU 2014 Industry Symposium provided a reflection on the management of innovation and technological breakthroughs in biotechnology first proposed to contextualize the key development milestones and constraints of allocation of financial resources, in the development life-cycle of radical innovation projects. This was illustrated with the biofuels story, sharing similarities with regenerative medicine. The transition was then ensured by an overview of the key identified challenges facing the commercialization of cell therapy products as ATMP examples. Real cases and testimonies were then provided by a palette of medical technologies and regenerative medicine companies from their commercial development of cell and gene therapy products. Although the commercial development of ATMP is still at the proof-of-concept stage due to technology risks, changing policies, changing markets, and management changes, the sector is highly dynamic with a number of explored therapeutic approaches, developed by using a large diversity of business models, both proposed by the experience, pitfalls, and successes of regenerative medicine pioneers, and adapted to the constraint resource allocation and environment in radical innovation projects.

By REBECCA SKLOOT

JEFFREY GRAY, a professor at Des Moines University, recently instructed a room full of medical students to take out their phones. Unlock them, he said. Now pass them to the person behind you. They looked at him like, Are you nuts? They wanted to know, Why? What will they look at? How will they use that information? (…)

See the article here

The EUCelLEX project wishes you

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Merry Christmas and Happy New Year!

Authors: Jeremy Magalon,Martin Maiers,Joanne Kurtzberg,Cristina Navarrete,Pablo Rubinstein, Colin Brown,Catherine Schramm,Jérome Larghero,Sandrine Katsahian,Christian Chabannon,Christophe Picard,Alexander Platz,  Alexander Schmidt,Gregory Katz.

Article in Open Access. PLoS ONE 10(12): e0143440. doi:10.1371/journal.pone.0143440

Cord blood is an important source of stem cells. However, nearly 90% of public cord blood banks have declared that they are struggling to maintain their financial sustainability and avoid bankruptcy. The objective of this study is to evaluate how characteristics of cord blood units influence their utilization, then use this information to model the economic viability and therapeutic value of different banking strategies.

Authors : Alessandro Blasimme, Ignacio Anegon, Jean-Paul Concordet, John De Vos, Anne Dubart-Kupperschmitt, Marc Fellous, Pierre Fouchet, Nelly Frydman, Carine Giovannangeli, Pierre Jouannet, Jean-Loius Serre, Julie Steffann, Emmanuelle Rial-Sebbag, Mogens Thomsen & Anne Cambon-Thomsen.

Article in Open Access. The American Journal of Bioethics, 15:12, 54-57, DOI:10.1080/15265161.2015.1103811.

When scientific discovery paves the way to previously unimagined possibilities, progress generates a mixture of thrill and preoccupation. That is what happened when CRISPR-Cas9 became known to the public through a perspective paper in Science magazine that, in April 2015,started an international debate…

Part of this work is supported by the EUCelLEX project.