It is never too late for cardiac repair stem cell administration for chronic ischaemic heart infarction (SCACIHI)

Abstract

BACKGROUND: myocardial infarction is a leading cause of death in humans around the world. Acute infarction leaves a print in heart walls (scar) that chronifies evolving to heart failure and probably death. This pathological mechanism accounts for million deaths just in Europe every year. Despite all medical advances and new strategies for treating acute and chronic infarction, there’s still a huge amount of morbility and mortality associated with infarction sequales. Regenerative Cardiac Medicine has emerged as an interesting concurrent therapy that could lead to healing and heart functionality improvement post infarction. Stem cell therapy has increased the therapeutic armamentarium in the figth against ischemic heart disease. Fort he past 20 years lots of studies and different products have emerged and demostrated safety profiles on clinical trials. On the other hand, none of them has managed to excel and accomplish clearly positive results, improving functionality, morbidity and mortality of these patients. Searching of the perfect solution it’s still going on and advances on the field have been positive so far. HYPOTHESES AND OBJECTIVES: cardiac resident cells have emerged as a promising product for ischemical patients. Interesting cardioprotective, immunoregulatory, and cardioregenerative properties have been demonstrated for human cardiac stem cells. They have already proved safety on “in vitro” and phase I and II clinical trials so medical community are looking forward to see safety and efficacy of this therapy on the clinical field. Our objective is to asses possible beneficial effects for chronic ischemical patients and to bring out possible short and long term side effects. DESIGN AND METHODS: this protocol has been designed as a prospective, double-blind, 2:1 randomized, controlled, and multicenter clinical trial that will evaluate safety, feasibility, and efficacy of intramyocardial delivery of allogeneic human cardiac stem cell in 150 patients with chronic myocardial infarction. We will divide the sample randomly in two comparable groups and study cardiac stem cells effect on treated group. A follow-up of 12 months will be performed to all patients, control and experimental group, with safety (serious adverse effects, MACE, death from any cause and cardiovascular death), clinical (complete blood analisis, NT-proBNP, PCR, inmunlogical assays, NYHA functional class, 6-min walking tests and Quality of life), ECO (and Doppler) and MRI parameters (Scar size, heart functionality and edema)