The epidemics of heart failure (HF) represents a challenge for the National Health System: despite advances over the past 30 years, the prognosis for patients who are admitted to hospital with HF remains poor, with a 5 year mortality that is nearly 50%, worse than that for patients with breast or colon cancer. The incidence of HF is dramatically increasing at an unanticipated speed emphasizing the need for novel strategies aiming at the identification of the cause of this devastating disease.
In the last few years, the Department of Cardiovascular Sciences of Università Cattolica del Sacro Cuore – Policlinico A. Gemelli, directed by Prof. Filippo Crea, contributed with original research programs in this field. Therefore, the Department has joined the European consortium that designed the clinical trial BAMI (The Effect of intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells on All Cause Mortality in Acute Myocardial Infarction ), and it will conduct the study as a coordinating center for Italy and European leading center for substudies.
Moreover, as the population continues to age, the demand for costly, age-associated health care will increase rapidly, since elderly individuals are at highest risk for HF. The European program "Horizon 2020: Health, demographic change and well-being" indicated the development of new therapeutic strategies that can bring a benefit in terms of survival and a reduction in the rate of hospitalization in patients with heart failure as an inescapable challenge. In recent years, therefore, regenerative medicine has been seen as a possible resource that can provide a convincing answer to this important socio-medical problem.
BAMI partners come from all over Europe and in Italy the poles are two: the coordinator for Italy the Catholic University of the Sacred Heart, and a second team comes from University of Pavia and Hospital “San Matteo” and it is led by Massimiliano Gnecchi.
What is the state of the art in the study of the consequences of myocardial infarction? We talked with Domenico D'Amario from the Catholic University team. “According to recent statistics,” says D'Amario, “in the United States each minute a person dies due to heart diseases. They are now the first cause of death in the western countries, and the estimates predict that costs to treat them will rise in the next 10 years by 120%.”
However, although the problem is becoming more and more important, “no current therapeutic option is focusing on answering the basic question: how to protect the surviving myocardium and possibly regenerate the part of the heart damaged by a heart attack, reversing the resultant dysfunction and ventricular remodeling,” D’Amario says.
In the setting of myocardial infarction, the immediate reopening of acutely occluded coronary arteries via primary angioplasty (PPCI) is the treatment of choice to salvage the ischemic myocardium. However, the sudden re-initiation of blood flow, can lead to a local acute inflammatory response with further endothelial and myocardial damage.
The BAMI project will try establishing the therapeutic value of this approach to stem cell therapy. In detail, the aim of BAMI is using trans-coronary infusion of bone marrow-derived progenitor cells to reduce the mortality rate by 25% and the re-hospitalisation rate by 15%.
In Europe, the entire clinical trial will involve 3000 patients suffering from myocardial infarction, 125 of which will be treated in Italy between the Policlinico A. Gemelli and Policlinico San Matteo. “Patients with successful acute reperfusion therapy within 24 hours of symptom onset and left ventricular ejection dysfunction assessed by quantitative echocardiography 3 to 6 days after reperfusion therapy” explains D'Amario. They will be randomized to the best hospital treatment or treated with the same state of the art therapy plus intracoronary infusions of adult autologous cells from the bone marrow. The recruitment will start in April in Italy and it will last 3 years. After this period, patients will be followed for other 2 years.
“The BAMI trial is the first and unique large scale clinical trial to test if bone marrow derived progenitor cells can lead to a significant reduction in all-cause mortality. If this is the case, we can use this new powerful tool in all patients affected by ischemic heart disease,” concludes D'Amario.
