Clinical trial NCT01454323: Intracoronary Infusion of Bone Marrow Mononuclear Cells in Patients With Previous Myocardial Infarction.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Myocardial Ischemia
Keywords: Chronic Myocardial Ischemia
Cell therapy
Bone marrow mononuclear cells
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Iniciativa Andaluza en Terapias Avanzadas
First posted: 2011-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

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 36 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 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.

Primary outcomes:
measure: Change from baseline in left ventricular ejection fraction (LVEF)
timeFrame: 3, 6 and 12 months after intervention
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 12 months
measure: Functional grade of the New York Heart Association (NYHA)
timeFrame: 3,6 and 12 months
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: University Hospital Reina Sofía
Study officials:
affiliation: University Hospital Reina Sofía, Córdoba.
name: Jose Suarez de lezo, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital Reina Sofía, Córdoba.
name: Inmaculada Herrera, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital Reina Sofía, Córdoba.
name: Miguel Ángel Romero, MD
role: PRINCIPAL_INVESTIGATOR
References: