Status:
COMPLETED
Intracoronary Infusion of Bone Marrow Mononuclear Cells in Patients With Previous Myocardial Infarction.
Lead Sponsor:
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Collaborating Sponsors:
Iniciativa Andaluza en Terapias Avanzadas
Conditions:
Chronic Myocardial Ischemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Phase II clinical trial which will include all patients diagnosed with chronic anterior myocardial infarction (more than 6 months from the acute phase and the complete revascularization in which it is...
Detailed Description
This is an uncontrolled study in which the efficacy of the cell therapy drug is measured by comparing the variables of ventricular function after treatment to the basal condition prior to its applicat...
Eligibility Criteria
Inclusion
- Aged between 18 and 80 years.
- Patients diagnosed with Chronic anterior myocardial infarction (more than 6 months from the acute episode) with symptoms and / or signs of heart failure.
- Left ventricular ejection fraction (LVEF)\<45% and distensibility changes.
- Complete revascularization performed at least 6 months before infusion cells.
Exclusion
- Patients in active waiting list for heart transplantation..
- Treatable patients with resynchronization.
- Patients over 80 years
- Coexistence of other serious systemic diseases.
- Active infection, HIV, Hepatitis B or Hepatitis C.
- Patients with malignant or pre-malignant tumours.
- Coexistence of any haematological disease.
- Pregnant women, in breastfeeding period, or in childbearing potential age who are not using effective contraception.
- Patients who are currently participating or have completed their participation in a clinical trial in a period of less than three months.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01454323
Start Date
December 1 2010
End Date
February 1 2015
Last Update
June 30 2015
Active Locations (1)
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1
University Hospital Reina Sofía
Córdoba, Spain, Spain, 14004