BAMI
The effect of intracoronary reinfusion of bone marrow-derived mononuclear cells (BM-MNC) on all-cause mortality in acute myocardial infarction
| Coordinatore | QUEEN MARY UNIVERSITY OF LONDON
Organization address
address: 327 MILE END ROAD contact info |
| Nazionalità Coordinatore | United Kingdom [UK] |
| Sito del progetto | http://www.bami-fp7.eu/ |
| Totale costo | 7˙840˙661 € |
| EC contributo | 5˙993˙083 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2011-two-stage |
| Funding Scheme | CP-FP |
| Anno di inizio | 2011 |
| Periodo (anno-mese-giorno) | 2011-11-01 - 2016-10-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
QUEEN MARY UNIVERSITY OF LONDON
Organization address
address: 327 MILE END ROAD contact info |
UK (LONDON) | coordinator | 1˙968˙222.00 |
| 2 |
KLINIKUM DER JOHANN WOLFGANG VON GOETHE UNIVERSITAET
Organization address
address: Theodor Stern Kai 7 contact info |
DE (FRANKFURT AM MAIN) | participant | 1˙143˙904.40 |
| 3 |
SERVICIO MADRILENO DE SALUD
Organization address
address: PLAZA CARLOS TRIAS BERTRAN 7 contact info |
ES (MADRID) | participant | 540˙710.60 |
| 4 |
KATHOLIEKE UNIVERSITEIT LEUVEN
Organization address
address: Oude Markt 13 contact info |
BE (LEUVEN) | participant | 476˙995.20 |
| 5 |
EURAM LIMITED
Organization address
address: "Tower House, Lucy Tower Street" contact info |
UK (LINCOLN) | participant | 257˙300.00 |
| 6 |
UNIVERSITA CATTOLICA DEL SACRO CUORE
Organization address
address: Largo Agostino Gemelli 1 contact info |
IT (MILANO) | participant | 205˙270.05 |
| 7 |
CARDIO3 BIOSCIENCES SA
Organization address
address: RUE EDOUARD BELIN 12 contact info |
BE (MONT SAINT GUIBERT) | participant | 185˙836.88 |
| 8 |
T2CURE GMBH
Organization address
address: KENNEDYALLEE 93 contact info |
DE (FRANKFURT AM MAIN) | participant | 163˙955.23 |
| 9 |
INSTITUT CATALA DE LA SALUT
Organization address
address: GRAN VIA DE LES CORTS CATALANES 587 contact info |
ES (BARCELONA) | participant | 154˙191.92 |
| 10 |
FAKULTNI NEMOCNICE BRNO
Organization address
address: JIHLAVSKA 20 contact info |
CZ (BRNO) | participant | 151˙882.62 |
| 11 |
KING'S COLLEGE HOSPITAL NHS TRUST
Organization address
address: DENMARK HILL 1 contact info |
UK (LONDON) | participant | 138˙265.48 |
| 12 |
REGION HOVEDSTADEN
Organization address
address: KONGENS VAENGE 2 contact info |
DK (HILLEROD) | participant | 136˙776.16 |
| 13 |
Nome Ente NON disponibile
Organization address
address: YLIOPISTONRANTA 1 E contact info |
FI (Kuopio) | participant | 113˙136.90 |
| 14 |
CARDIOVASCULAR RESEARCH CENTER AALST VZW
Organization address
address: MOORSELBAAN 164 contact info |
BE (AALST) | participant | 111˙275.00 |
| 15 |
?l?ski Uniwersytet Medyczny w Katowicach
Organization address
address: Poniatowskiego 15 contact info |
PL (Katowice) | participant | 110˙190.74 |
| 16 |
THE UNIVERSITY OF EXETER
Organization address
address: Northcote House, The Queen's Drive contact info |
UK (EXETER) | participant | 71˙478.40 |
| 17 |
MEDIZINISCHE HOCHSCHULE HANNOVER
Organization address
address: Carl-Neuberg-Strasse 1 contact info |
DE (HANNOVER) | participant | 22˙464.12 |
| 18 |
UNIVERSITY COLLEGE LONDON
Organization address
address: GOWER STREET contact info |
UK (LONDON) | participant | 21˙384.89 |
| 19 |
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Organization address
address: 3 Avenue Victoria contact info |
FR (PARIS) | participant | 19˙842.43 |
| 20 |
JOHANN WOLFGANG GOETHE UNIVERSITAET FRANKFURT AM MAIN
Organization address
address: GRUNEBURGPLATZ 1 contact info |
DE (FRANKFURT AM MAIN) | participant | 0.00 |
| 21 |
OSLO UNIVERSITETSSYKEHUS HF
Organization address
address: FORSKNINGSVEIEN 2B contact info |
NO (OSLO) | participant | 0.00 |
| 22 |
UNIVERSITAET ROSTOCK
Organization address
address: UNIVERSITATSPLATZ 1 contact info |
DE (ROSTOCK) | participant | 0.00 |
Mappa
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Obiettivo del progetto (Objective)
'Although the long term prognosis of patients suffering acute myocardial infarction (AMI) has improved since the introduction of reperfusion therapies and primary angioplasty, the 1 year mortality of patients with AMI and resultant left ventricular systolic dysfunction (LVSD) is still as high as 13%. A major reason for the high morbidity and mortality is that the heart has an inadequate regenerative response to the myocardial necrosis sustained following AMI; cell death from the ischaemic damage can lead to progressive ventricular dilation and dysfunction through the processes of vascular remodelling. Despite the use of full conventional treatment, including ACE inhibitors, beta-blockers, aldosterone inhibitors and diuretics, yearly mortality rates of patients with post-infarction heart failure are still in the range of 13 % and rehospitalisation for worsening of heart failure occurs at a yearly rate of 6–8%.
Clinical data now exists supporting the concept that autologous bone marrow derived cells can restore cardiac function following AMI. We plan to advance this research in the BAMI project and will: • Develop a standardised method of bone marrow cell collection • Develop a standardised method of optimising reparative potential of bone marrow derived cells • Standardise bone marrow preparation procedure so that it can be universally applied • Standardise method of bone marrow cell delivery post AMI • Conduct the first large scale all course mortality clinical trial to test if the product and delivery method mentioned above can lead to a 25% reduction in mortality end-point at 2 years
Our project will establish the therapeutic value of this approach to stem cell therapy. Success will demonstrate that transcoronary infusion of bone marrow-derived progenitor cells is safe and will reduce the mortality rate by 25% and reduce the rehospitalisation rate by 15%.'
Introduzione (Teaser)
A European consortium is testing the efficacy of a cell therapy approach for the treatment of acute myocardial infarction (AMI).
Descrizione progetto (Article)
Following AMI, the necrosed area of the heart displays a limited regenerative response. Although long term prognosis has improved with the introduction of reperfusion therapies, in certain cases mortality can be high.
Over the past decade a number of studies have demonstrated the clinical efficacy of administering autologous bone marrow derived mononuclear cells (BM-MNC) after an AMI. The EU-funded http://www.bami-fp7.eu/ (BAMI) (The effect of intracoronary reinfusion of bone marrow-derived mononuclear cells (BM-MNC) on all-cause mortality in acute myocardial infarction) project wants to establish whether BM-MNC therapy is more beneficial than standard reperfusion therapy.
The consortium is conducting a Phase III multi-national, randomised and controlled study to demonstrate that an intracoronary infusion of autologous BM-MNC is superior compared to optimal reperfusion therapy alone. So far partners have compared different methods for bone marrow processing to deliver the desired mononuclear cell fraction. The optimal method for BM-MNC preparation has been further standardised so that it could be delivered in hospitals across the EU.
In addition, scientists have selected the best route for BM-MNC delivery. In the context of AMI, intracoronary infusion is usually employed to administer the cells since it is supported by evidence and safety data. The technique entails balloon angioplasty and cell infusion through an over-the-wire (OTW) balloon. The clinical trial will take place in eight participating countries with an additional 12 active satellite sites across Europe, which have recruited a total of 84 patients so far.
Taken together, the BAMI study will provide solid evidence on the efficacy of BM-MNC therapy in patients undergoing primary angioplasty. Considering the economic losses incurred from patient sick leave or incapacity to work due to chronic disease, an improved therapeutic intervention should reduce hospitalisation and mortality rates.