To determine the efficacy of intracoronary infusion of bone marrow mononuclear cells in patients with autologous chronic coronary occlusion previously revascularized with stents in terms of improvement of ventricular function determined by magnetic resonance image.

Phase 1

• Conditions: Chronic coronary occlusion; MedDRA version: 14.1Level: PTClassification code 10011086Term: Coronary artery occlusionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000915-26-ES
• Lead Sponsor: FUNDACIÓN PROGRESO Y SALUD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-09
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. - Patients of both sexes with atherosclerotic coronary disease and chronic occlusions older than 3 months that has been achieved successful recanalization, medicated stents implanted, and where it persists despite ventricular dysfunction.
2.-Age between 18 and 80 years.
2. - The baseline ventricular function recanalization catheterization (performed approximately 3 months earlier) should be less than 45% ejection fraction.
3. - In the magnetic resonance image performed at 3 months of recanalization, the ejection fraction of the patient should remain below 45%.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. - Patients with chronic occlusion recanalizadas not successful.
2. - Patients with improvement of ejection fraction to values ??above 45% at 3 months after recanalization ..
3. - Positive serology for HIV, HCV or HBV.
4. - Coexistence of other serious systemic diseases or contraindications to dual antiplatelet therapy (clopidogrel and aspirin).
5. - Coexistence of any blood disease.
6. - Pregnant women, lactating, or of childbearing potential not using effective contraception.
7. - Patients who are currently participating or have completed their participation in a clinical trial in a period of less than three months.
8. - Patients with malignant or pre-malignant.
9. - Patients who can not perform a magnetic resonance device being metallic carrier (prosthesis, defibrillators, pacemakers etc.).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified