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

This study is currently recruiting participants.
Verified December 2012 by Fundación Pública Andaluza Progreso y Salud
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01454323
First received: October 12, 2011
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Chronic Myocardial Ischemia
Other: Bone marrow mononuclear cells
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial on the Effect of Intracoronary Infusion of Bone Marrow Mononuclear Cells on Functional Recovery in Patients With Myocardial Chronic Back and Severely Depressed Left Ventricular Function.

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Change from baseline in left ventricular ejection fraction (LVEF) [ Time Frame: 3, 6 and 12 months after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Functional grade of the New York Heart Association (NYHA) [ Time Frame: 3,6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Dose of bone marrow mononuclear cells: 5-7 x 108 total cells
Other: Bone marrow mononuclear cells
Intracoronary infusion of autologous bone marrow-derived mononuclear cells

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 application

The total number of patients to be studied 20. The study population will correspond to male and female patients with chronic anterior myocardial infarction (more than 6 months after the acute episode) and ventricular dysfunction. It is expected 24 months of inclusion and one year follow up

Patients will receive in a concomitant way the drug treatment established by the good practice, so it would certainly be possible that some improvement occurs due to drug treatment.

It will be studied the patient population of both genders aged between 18 and 80 years diagnosed with Chronic anterior myocardial infarction (more than 6 months after the acute phase and the complete revascularization).

Objectives of the study:

  • Main objective: To determine the efficacy of intracoronary injection of adult stem cells from autologous bone marrow in patients with chronic anterior myocardial infarction in terms of improvement of ventricular function, determined by hemodynamic, echocardiographic and New York Heart Association (NYHA) functional class criteria, resulting in an improvement of heart failure symptoms and quality of life's patient.
  • Secondary objectives:

    1. To investigate the basic cellular mechanisms underlying the myocardial regeneration process through correlation between hemodynamic criteria for the ventricular function improvement and the biologicals corresponding to the composition and the functionality of the infused cells.
    2. To analyze clinical, hemodynamic and biologicals factors able to influence favorably to a greater degree of functional recovery after regenerative treatment in chronic myocardial infarction.
    3. To design, in view of the results obtained, suitable protocol for the application of cell therapy to treat patients with old anterior infarction, both in terms of the ideal characteristics of medullary graft as in terms of those patients more likely to be beneficiaries of it, in order to establish a definitive strategy of including cell therapy in the standard treatment of this disease in the near future provided that the results indicate it so.

The primary variable is the improvement in ventricular function monitoring under angiographic and echocardiographic parameters.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged between 18 and 80 years.
  2. Patients diagnosed with Chronic anterior myocardial infarction (more than 6 months from the acute episode) with symptoms and / or signs of heart failure.
  3. Left ventricular ejection fraction (LVEF)<45% and distensibility changes.
  4. Complete revascularization performed at least 6 months before infusion cells.

Exclusion Criteria:

  1. Patients in active waiting list for heart transplantation..
  2. Treatable patients with resynchronization.
  3. Patients over 80 years
  4. Coexistence of other serious systemic diseases.
  5. Active infection, HIV, Hepatitis B or Hepatitis C.
  6. Patients with malignant or pre-malignant tumours.
  7. Coexistence of any haematological disease.
  8. Pregnant women, in breastfeeding period, or in childbearing potential age who are not using effective contraception.
  9. Patients who are currently participating or have completed their participation in a clinical trial in a period of less than three months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454323

Contacts
Contact: Ana Cardesa 0034 955019040 ana.cardesa@juntadeandalucia.es

Locations
Spain
University Hospital Reina Sofía Recruiting
Cordoba, Spain, 14004
Contact: Miguel Romero, MD,PhD       mromero@grupocorpal.com   
Principal Investigator: Miguel Romero, MD, PhD         
Sub-Investigator: Jose Suarez de Lezo, MD,PhD         
Sub-Investigator: Manuel Pan, MD, PhD         
Sub-Investigator: Inmaculada Herrera, MD, PhD         
Sub-Investigator: Djorge Pavlovic, MD,PhD         
Sub-Investigator: Soledad Ojeda, MD,PhD         
Sub-Investigator: Javier Suarez de Lezo, MD,PhD         
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
Study Chair: Jose Suarez de lezo, MD, PhD University Hospital Reina Sofía, Córdoba.
Study Chair: Inmaculada Herrera, MD, PhD University Hospital Reina Sofía, Córdoba.
Principal Investigator: Miguel Ángel Romero, MD University Hospital Reina Sofía, Córdoba.
  More Information

Additional Information:
No publications provided

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01454323     History of Changes
Other Study ID Numbers: CMMo/CIC/2009, 2009-016599-66
Study First Received: October 12, 2011
Last Updated: December 17, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundación Pública Andaluza Progreso y Salud:
Chronic Myocardial Ischemia
Cell therapy
Bone marrow mononuclear cells

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014