• 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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The EUcelLex project is thrilled to announce the workshop «Umbilical Cord Blood Banking Workshop» to be held in Toulouse, on 3rd December 2015. The workshop is organised in collaboration with the COST Action CHIPme.

PROGRAMME UPDATED !

More information here.

Participation is possible after registration. The number of participants is limited.

Authors : Kirstin R. W. Matthews and Ana S. Iltis.

Article in BMC Medical Ethics. BMC Medical Ethics 2015, 16:75  doi:10.1186/s12910-015-0069-x

Discussion: In this paper, we argue that the continued marketing and use of experimental stem cell-based interventions is problematic and unsustainable. Central problems include the lack of patient protection, US liability standards, regulation of clinical sites, and clinician licensing. These interventions have insufficient evidence of safety and efficacy; patients may be wasting money and time, and they may be forgoing other opportunities for an intervention that has not been shown to be safe and effective. Current practices do not contribute to scientific progress because the data from the procedures are unsuitable for follow-up research to measure outcomes. In addition, there is no assurance for patients that they are receiving the interventions promised or of what dosage they are receiving. Furthermore, there is inconsistent or non-existent follow-up care. Public policy should be developed to correct the current situation.

This article is part of the series Driving Regenerative Medicine to the Market and Clinic: An Exploration of Enablers, Impediments and Ethical-Legal Challenges.

Article en Open Acces here.

REGenableMed (2014-2017) is an ESRC-funded social science project examining the ways in which institutions and agencies are interacting and ‘readying’ themselves for regenerative medicine (RM), focusing mainly on  the UK. It identifies the various institutional, legal, social and political factors that enable and hinder the development of new RM/stem  cell therapies.

This Policy Briefing 2015 is the first of a regular series of reports.

Authors: Michael Mendicino and Darin Weber.

Article in Stem Cells in Regenerative Medicine: Science, Regulation and Business Strategies, published by Alain A. Vertes,Nasib Qureshi,Arnold I. Caplan,Lee Babiss. ISBN: 978-1-119-97139-9. 776 pages. November 2015, Wiley-Blackwell.

Stem cells, as therapeutic agents or as research or diagnostics tools, represent an emerging technology with a transformational potential that parallels the paradigm shift operated by the development of monoclonal antibodies in the 1990s, or even the coming of age of genetic engineering technology platforms in the 1980s. Those working with stem cell technologies face a complex matrix of ethical, regulatory, policy, logistics, supply chain, manufacturing, pricing and reimbursement challenges. (…)

Authors: Hermes Taylor-Weiner, Ph.D., and Joshua Graff Zivin, Ph.D.

Article in The New England Journal of Medicine. Perspective (September 10, 2015)

N Engl J Med 2015; 373:985-987 (DOI: 10.1056/NEJMp1504560).

In recent decades, there has been tremendous hope that stem-cell–based technologies would introduce a new era of regenerative medicine, revolutionizing the treatment of disease. These hopes have been stoked by reports that often emphasize promising findings without adequately acknowledging the many remaining challenges. Although stem-cell therapy may hold great potential, the field is less advanced than the public has been led to believe. Stem-cell clinics in the United States and abroad have capitalized on this confusion by selling treatments that are not approved by the Food and Drug Administration (FDA), supported by clinical studies, or covered by insurers.

More information here