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Ethics of stem cell clinical trials

Egenis Senior Research Fellow, Dr Christine Hauskeller is a partner in a new European research project undertaking a clinical trial of adult stem cell therapy.  The trial aims to show that the survival after a heart attack can be improved when patients are treated with their own stem cells directly after the attack.

The University of Exeter is one of 21 partners from 11 European countries in this € 5.9 Million research project, known as BAMI and is funded by the European Union.

3000 patients will be recruited into the trial throughout the European Union. The patients will be treated with stem cells taken from their bone marrow and injected into their heart within a few days of the heart attack. It is hoped that the intervention could increase survival rates by a quarter and improved well-being.

Trial Chief Co-ordinator, Professor Anthony Mathur, Bart’s and the London NHS Trust and Queen Mary, University of London NIHR said:“Our studies will tell us if adult stem cells in bone marrow can repair damaged hearts and, if so, how these cells should be administered to patients.”

Cross-national research faces many hurdles which affect not only medical research but also the implementation of innovative treatments. These hurdles are a grave concern for medical science and pharmaceutical industry.

Standardisation and ethical harmonisation in medical science across Europe are of grave concern for medicine, patient care and industry. Dr Hauskeller and her team are collecting data and are interviewing 50 trial practitioners from across the participating hospitals and institutions about practical issues in getting the trial started.

Dr Hauskeller explained:“Putting such a trial into practice is extremely complex. It took BAMI nearly two years of hard work until we recruited the first patient. The team overcame many practical, technical, logistical and regulatory problems. In addition, differences in how hospitals work with national health authorities and ethics approvals had to be gained.”

She added:“The Exeter team contributes social science and ethics expertise to BAMI. We will systematically record and analyse what happened and how the trial proceeds across the partner nations. This provides valuable, concrete information for the improvement of European Ethical Harmonisation protocols and policies on international medical innovation.”

This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 278967.

Read media information about BAMI stem cell research.

Date: 24 February 2014