4 January 2012

The largest trial of adult stem cell therapy in patients has received funding from the European Union. 3000 patients suffering heart attacks will be recruited into the trial throughout the European Union to test whether stem cells administered shortly after the heart attack will prolong life. Stem cells  offer the promise of revolutionary treatment for human disease.  However, a definitive test of whether they work or not in this specific case of heart treatment has been lacking.  This study will provide the answer.

This is the largest trial of its kind, and it is hoped that it could increase survival rates by a quarter among patients having heart attacks. The study (BAMI) has been made possible thanks to a €5.9 million award from the European Commission. The BAMI study will involve 21 partners in 11 European countries.  The results will be announced in five years and is designed to test whether stem cell therapy will save lives.

Globally, more than 17m* people died from cardiovascular diseases last year – more than from any other cause. This landmark trial is being led by Professor Anthony Mathur and colleagues from Barts and the London NHS Trust and Queen Mary, University of London NIHR Cardiovascular Biomedical Research Unit.   

Trial Chief Co-ordinator, Professor Mathur, said:  “This is the biggest and most comprehensive trials of its kind in the world.”   

“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.”

Three thousand patients will have their own stem cells taken from their bone marrow and injected into their heart within five days of suffering a heart attack.

Professor Mathur said: “This study will determine if adult stem cells can save lives in heart attack patients across Europe.”

Professor John Martin (University College London) a partner in the trials said:   “This trial brings together a powerful partnership of European doctors and scientists to solve a fundamental problem of importance to all people.  It will give an answer about whether adult multi-potential stem cells in their natural environment can treat human disease.”

The new BAMI trial is much larger in size and scope, building on their previous work in this field.

The BAMI project has been funded by the European Union Seventh Framework Programme for Research and Innovation (FP7).

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Notes to Editors:

1.) Interview requests should be directed to Angela Boon in the Barts and The London Press Office on 0207 480 4843 or email:  angela.boon@bartsandthelondon.nhs.uk
2) The full project title is ‘The effect of intracoronary reinfusion of bone marrow-derived mononuclear cells (BM-MNC) on all-cause mortality in acute myocardial infarction.’ (Project Acronym: BAMI)
3)* Cardiovascular diseases are the world’s largest killers, claiming 17.3 million lives a year. Risk factors for heart disease and stroke include raised blood pressure, cholesterol and glucose levels, smoking, inadequate intake of fruit and vegetables, overweight, obesity and physical inactivity. World Health Organisation, Sep ‘11
4.) The 21 partners in BAMI are QMUL, Assistance Publique Hopitaux de Paris, Katholieke Universiteit Leuven, Johann Wolfgang Goethe Universitaet Frankfurt Am Main, Institut Catala de la Salut, EURAM Ltd, University College London t2cure GmbH, Cardiovascular Research Center Aalst VZW, Medizinische Hochschule Hannover, Fakultni Nemocnice BRNO (University Hospital BRNO), Region Hovedstaden (Rigshospitalet University Hospital Copenhagen), Universita Cattolica del Sacro Cuore (Catholic University of Rome), King’s College Hospital NHS Trust, Śląski Uniwersytet Medyczny w Katowicach  (Medical University of Silesia), Universitaet Rostock (Rostock University), Cardio3 BioSciences S.A, Itä-Suomen yliopisto (University of Finland), Oslo Universitetssykehus Hf (Oslo University Hospital), Servicio Madrileno de Salud, The University of Exeter
5) Existing heart stem cell trials at The London Chest
The REGENERATE (Heart Stem Cell) Trial at Barts and The London NHS Trust runs for four years and is made up of three randomised-controlled studies:
•    The REGENERATE-IHD Study involves 300 patients with heart failure caused by ischaemic heart disease (IHD) or a previous heart attack. Patients are randomised into three groups. The first group receive injections of G-CSF, a growth factor that stimulates bone marrow, once a day for five consecutive days. Those in the second and third group receive these injections and undergo a procedure to have stem cells extracted from bone marrow in their hip. These cells are ‘purified’ in the Trust’s stem cell laboratory to separate them from serum also found in bone marrow. Within the second group, half of patients have their stem cells injected into their major coronary arteries via a catheter in a minimally invasive operation while the other half have their serum injected into their major coronary arteries. Within the third group, half will have their stem cells injected directly into their heart muscle while the other half will have their serum injected directly into their heart muscle.
•    The REGENERATE-DCM Study involves 200 patients with heart failure caused by idiopathic dilated cardiomyopathy (DCM). Patients are randomised into two groups. The first group receive injections of G-CSF in their arm once a day for five consecutive days. The second group receive these injections and undergo a procedure to have stem cells extracted from their bone marrow in their hip. These cells are ‘purified’ in the Trust’s stem cell laboratory to separate them from serum also found in bone marrow. Within the second group, half will have their stem cells injected into their major coronary arteries via a catheter while the other half will have their serum injected into their major coronary arteries.
•    The REGENERATE-AMI Study involves 100 patients with recent acute myocardial infarction (AMI) or heart attack. Patients have stem cells extracted from bone marrow in their hip shortly after undergoing a primary or emergency angioplasty to clear the blockage that triggered their heart attack. These cells are purified in the Trust’s stem cell laboratory to separate them from serum also found in bone marrow. Half of patients will have their stem cells injected directly into their major coronary arteries via a catheter while the other half will have their serum injected into their major coronary arteries.

Heart Cells Foundation
The Heart Cells Foundation is a registered charity (No. 1101727). It was set up in January 2004 to raise money to fund research into stem cells for the treatment of heart disease. Its trustees are Jenifer Rosenberg, Professor Anthony Mathur (advisor), Professor Martin Rothman, Professor John Martin, Sir Bernard Rix, Mrya Waiman, Stephen Sampson and Stephen James.  
 
Additional information

Barts and The London NHS Trust
Barts and The London NHS Trust is one of Britain’s top teaching hospital trusts. Over 500,000 people from the City, East London and further afield are treated at the Trust every year. The Trust is made up of three hospitals - Barts in the City, The Royal London in Whitechapel and The London Chest Hospital in Bethnal Green.

Queen Mary, University of London
Queen Mary, University of London is one of the UK’s leading research-focused higher education institutions with some 16,000 students and postgraduate students.

Amongst the largest of the colleges of the University of London, Queen Mary’s 3,000 staff deliver world-class degree programmes and research across three faculties: Science and Engineering; Humanities and Social Sciences and the School of Medicine and Dentistry.

One of the rising stars in the UK higher education, Queen Mary was ranked 11th nationally in the last Research Assessment Exercise, and was rated as one of the world’s elite universities in the 2010 Times Higher Education’s Top 200 World University Rankings (120th place).

The College has a strong international reputation with around 23 per cent of students coming from over 130 countries.

Queen Mary has an annual turnover of £300m, research income worth £70m, and a yearly impact on the UK economy of over £750m.

Queen Mary, as a member of the 1994 Group of research-focused universities, has made a strategic commitment to the highest quality of research, but also to the best possible educational, cultural and social experience for its students. The College is unique among London’s universities in being able to offer a completely integrated residential campus, with a 2,000-bed award-winning Student Village on its Mile End campus.