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Intracoronary Infusion of Bone Marrow Mononuclear Cells in Patients With Previous Myocardial Infarction.

NCT01454323 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-06-30

No results posted yet for this study

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 assessed the evolution of left ventricular function in patients to the monitoring against their own basal condition.

Included patients will be studied in the following conditions:

* Basal condition: defined as the immediately preceding to the administration of cell therapy treatment.
* Monitoring Condition 1: three months after drug administration of cell therapy. Includes non-invasive methods of exploration of ventricular function.
* Monitoring Condition 2: six months after administration of treatment. Includes the same methods of exploration of ventricular function practised in the basal condition, including cardiac catheterism as well as non invasive methods.
* Monitoring Condition 3: twelve months after administration of the cell therapy drug. Includes non-invasive methods of exploration of ventricular function.

The trial hypothesis we propose consists of mononuclear cells of bone marrow providing progenitor cells with regenerative capacity and also secreting several angiogenic factors, and their implantation into ischemic tissues should contribute with both elements to the angiogenesis and tissue regeneration with myocardial functional recovery

Conditions

  • Chronic Myocardial Ischemia

Interventions

OTHER

Bone marrow mononuclear cells

Intracoronary infusion of autologous bone marrow-derived mononuclear cells

Sponsors & Collaborators

  • Iniciativa Andaluza en Terapias Avanzadas

    collaborator OTHER

  • Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

    lead OTHER

Principal Investigators

  • Jose Suarez de lezo, MD, PhD · University Hospital Reina Sofía, Córdoba.

  • Inmaculada Herrera, MD, PhD · University Hospital Reina Sofía, Córdoba.

  • Miguel Ángel Romero, MD · University Hospital Reina Sofía, Córdoba.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01454323 on ClinicalTrials.gov