Treatment With Autologous Skeletal Myoblasts

NCT ID: NCT00975234

Last Updated: 2012-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-01-31

Brief Summary

The purpose of this study is to determine the benefit of autologous skeletal myoblast injection in patients with old myocardial infarction and ventricular dysfunction versus conventional revascularisation therapy.

Detailed Description

Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. Depending on the area affected by the scar, infarction can lead to a progressive and irreversible decline in cardiac function, giving way to heart failure (HF) syndrome. The molecular basis of congestive heart failure is the absence of cardiac stem cells capable of regenerating cardiac muscle. In the skeletal muscle, there are cells located beneath the basal membrane with are capable of regenerating muscle fibres; they are known as myoblasts. There are several studies with autologous myoblasts, either by direct administration during surgery or percutaneously, which could distinguish between the effect of revascularisation surgery and that of the myoblast injection. The objective of this study is compare improvement in global and regional cardiac function in patients with old MI obtained by aortocoronary bypass surgery with intracardiac administration of autologous skeletal myoblasts versus standard aortocoronary bypass surgery treatment.

Conditions

Old Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Skeletal myoblasts

Patients who are receiving skeletal myoblasts

Group Type: EXPERIMENTAL

Intra-lesion injection of autologous skeletal myoblasts

Intervention Type: PROCEDURE

Intra-lesion injection

Revascularisation

Intervention Type: PROCEDURE

Revascularisation surgery

Placebo

Revascularisation surgery

Group Type: PLACEBO_COMPARATOR

Revascularisation

Intervention Type: PROCEDURE

Revascularisation surgery

Interventions

Intra-lesion injection of autologous skeletal myoblasts

Intra-lesion injection

Intervention Type: PROCEDURE

Revascularisation

Revascularisation surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with a diagnosis of coronary disease obtained by coronary angiography who require conventional aortocoronary bypass surgery.
• History of myocardial infarction with evidence of regional akinesis (or dyskinesia) for more than 4 weeks and less than 10 years.
• Ejection fraction from 25% to 45%.
• Evidence of no regional viability by dobutamine echocardiography.
• Aged from 30-80 years old.
• Negative serology to HIV, HBV and HCV.
• Patients without organ dysfunction.
• Negative pregnancy test (women of childbearing age).
• Informed consent granted.

Exclusion Criteria

• History of myocardial infarction in the 4 weeks prior to the inclusion in the study.
• Prior history of tachycardia or ventricular fibrillation (except in patients with DAI device).
• History of cancer (except basocellular carcinoma) or prior treatment with chemotherapy.
• The patient should not suffer from any concomitant severe and/or uncontrolled medical condition.
• Patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol.
• Pregnant or beast feeding women.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fina Biotech

UNKNOWN

Sponsor Role: collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felipe Prósper, MD, PhD

Role: STUDY_DIRECTOR

Clinica Universidad de Navarra

Locations

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Galicia, Spain

Hospital Gregorio Marañón

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, Salamanca, Spain

Hospital La Fe

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

Mio/Reg/Quirur/Aleatorizado

Identifier Type: -

Identifier Source: org_study_id