Miocardiopatía dilatada de origen idiopático Idiopathic Dilated Cardiomyopathy MedDRA version: 9.1 Level: LLT Classification code 10059868 Term: Non-ischemic dilated cardiomyopathy
Conditions
Interventions
Product Name: Bone marrow mononuclear cells
Product Code: BMMNC
Pharmaceutical Form: Injection*
Sponsors
AININCAR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed of established of Idiopathic Dilated Cardiomyopathy 2) Left ventricular ejection fraction=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Dilated Cardiomyopathy of alcoholic or toxic origin 2) Patients older than 80 years 3) Miocarditis 4) Need for resinchronization 5) Being included in the waiting list for heart transplant 6) Pregnancy 7) Patients with any hematological disease 8) Patients with any other systemic disorder 9) Patients with any malignant or premalignat disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aim of the trial is to determine whether the intracoronary infusion of autologous bone marrow-derived stem cells is associated with improved ventricular function in patients with idiopathic dilated cardiomyopathy;Secondary Objective: We will try to correlate the level of the improvement in ventricular function with the cell content and the biological characteristics of the infused marrow.;Primary end point(s): 1) Improvement of the Left Ventricular function at the follow-up (6 months and 12 months) measured by angiography, magnetic nuclear resonance, echocardiography and treadmill direct oxygen comsumption 2) Improvement of the NYHA functional grade and quality of life | — |
Countries
Spain
Outcome results
None listed