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.

Clinical Trial Phase III single-center, open-label efficacy of intracoronary infusion of bone marrow mononuclear cells in patients with occlusion Autologous chronic coronary revascularization and ventricular dysfunction previously

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000915-26-ES

Enrollment

Registered

2013-04-09

Start date

2013-09-17

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic coronary occlusion MedDRA version: 14.1 Level: PT Classification code 10011086 Term: Coronary artery occlusion System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: Células Mononucleadas de Médula Ósea Autóloga Pharmaceutical Form: Solution for infusion INN or Proposed INN: NA CAS Number: NA Current Sponsor code: NA Other descriptive name: Mononucle

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.).

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 1. - To design, in view of the results obtained, a protocol best suited for the treatment of chronic coronary occlusion. 2. - To study the changes in the functional status of these patients. 3 - Analysis of potential cardiac events during follow-up (death, myocardial infarction, repeat revascularization). 4. - Study of changes in global and segmental function of the left ventricle through the study of myocardial deformation dimensional speckle tracking echocardiography (EST2D) and three-dimensional echocardiography comparatively amongst patients and between groups;Primary end point(s): The primary endpoint will be the change in ejection fraction measured by magnetic resonance image between inclusion and at 6 months follow-up;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 1. - To design, in view of the results obtained, a protocol best suited for the treatment of chronic coronary occlusion. 2. - To study the changes in the functional status of these patients. 3 - Analysis of potential cardiac events during follow-up (death, myocardial infarction, repeat revascularization). 4. - Study of changes in global and segmental function of the left ventricle through the study of myocardial deformation dimensional speckle tracking echocardiography (EST2D) and three-dimensional echocardiography comparatively amongst patients and between groups;Primary end point(s): The primary endpoint will be the change in ejection fraction measured by magnetic resonance image between inclusion and at 6 months follow-up;Timepoint(s) of evaluation of this end point: Not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Grade Changes NYHA functional comparatively between groups. 2. Possible cardiac events during follow-up (death, myocardial infarction, repeat revascularization). 3. Need for hospitalization or major arrhythmias. It will assess the presence or absence of symptoms or arrhythmias during the 6 month follow-up. To do this, patients will be followed from the clinical point of view so close, with frequent phone calls and periodic revisions of an outpatient hospital. 4. Changes in global function and left ventricular segmental by studying myocardial deformation dimensional speckle tracking echocardiography (EST2D) and three-dimensional echocardiography in a comparison between the conditions for monitoring in each patient and between groups.;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Secondary end point(s): 1. Grade Changes NYHA functional comparatively between groups. 2. Possible cardiac events during follow-up (death, myocardial infarction, repeat revascularization). 3. Need for hospitalization or major arrhythmias. It will assess the presence or absence of symptoms or arrhythmias during the 6 month follow-up. To do this, patients will be followed from the clinical point of view so close, with frequent phone calls and periodic revisions of an outpatient hospital. 4. Changes in global function and left ventricular segmental by studying myocardial deformation dimensional speckle tracking echocardiography (EST2D) and three-dimensional echocardiography in a comparison between the conditions for monitoring in each patient and between groups.;Timepoint(s) of evaluation of this end point: Not applicable

—

Countries

Spain

Contacts

Public ContactAna Cardesa Gil

FUNDACIÓN PROGRESO Y SALUD

ana.cardesa@juntadeandalucia.es0034955019040

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026