Clinical trial phase IIb multicenter, double-blind, randomized, placebo-controlled trial evaluating the efficacy of intracoronary infusion of autologous adult mononuclear bone marrow unexpanded on functional recovery in patients with dilated cardiomyopathy of idiopathic origin and heart failure.

简要总结

主要结局

次要结局

• EFFICACY - PATIENT. Changes in the following parameters: Clinical evaluation and determination of NYHA functional class; Determination of BNP or NT fragment; Full echocardiogram; Assessment of functional capacity by exercise test without measurement of oxygen consumption; And cardiac catheterization.
• EFFICACY - PATIENT. Evolution time from the diagnosis of idiopathic MD to the inclusion of the patient in the clinical trial.
• EFFICACY - PATIENT. The degree of clinical improvement based on the absence of major cardiac events (MACE) during follow-up (severe arrhythmias, all cause death, cardiac death, cardiac hospitalization, inclusion in heart transplantation waiting list).
• EFFICACY - PATIENT. The presence or absence of symptoms or arrhythmias and clinical functional degree. To this end, patients will be followed closely from a clinical point of view, with frequent telephone calls and periodic hospital check-ups on an outpatient basis.
• EFFICACY - Laboratory of the cellular therapy medicinal product: Automatic cell counting to determine the total cellularity infused; Determination of the cellular composition in terms of the content of immature progenitors, endothelial line progenitors, mesenchymal line progenitors, expression of adhesion molecules, contamination of red blood cells in the cellular content and expression of the various membrane markers; Functional analysis of the chemotactic capacity of the infused cells.
• SAFETY. Adverse events and Laboratory determinations: Cellular therapy medicinal product (microbiological cultivation) and Analytical determinations of blood count, plasma coagulation study and biochemistry on the patient.