Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction

Phase 2

Terminated

• Conditions: Old Myocardial Infarction
• Interventions: Procedure: Cardiac revascularization; Procedure: Percutaneous autologous myoblast implantation

• Registration Number: NCT00908622
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

The purpose of this study is compare the improvement in global and regional cardiac function measured by echocardiography and magnetic resonance in patients with old myocardial infarction subject to cardiac catheterisation with percutaneous endocavity implantation of autologous myoblasts.

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. In the last few years, new treatments have been developed for the acute phase of myocardial infarction.We have managed to slow down disease progression with these new treatments, but it continues to the development of end stage heart failure. This study tries to determine the benefit of cell cardiomyoplasty with autologous myoblasts in patients with old MI.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2009-05-25
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-10
• Last Update Posted: 2015-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients with diagnosis of myocardial infarction, absence of viability.
• Ejection fraction under 40% or 45% in symptomatic patients
• Aged from 30-80 years old.
• Negative pregnancy test (women of childbearing age)
• Informed consent granted

Exclusion Criteria

• Prior history of tachycardia or ventricular fibrillation (except in the acute phase of MI).
• Myocardial infarction with more than 10 years of evolution.
• Patients positive for HIV, HBV or HCB.
• Patients with organ dysfunction: liver and kidney function
• History of cancer 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No cells	Cardiac revascularization	Percutaneous culture medium without cells implantation
Skeletal myoblasts	Percutaneous autologous myoblast implantation	Percutaneous autologous myoblast implantation

Primary Outcome Measures

Name	Time	Method
Ejection fraction and wall motion score index measured with M-mode and echocardiography	12 months after surgery

Secondary Outcome Measures

Name	Time	Method
Ejection fraction measured with echocardiography in the ITT population	12 month after surgery
Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population	12 month after surgery
Viability measured with echocardigraphy and magnetic resonance in the ITT population	12 month after surgery
Incidence of cardiac arrythmias in the ITT population	12 month after surgery

Trial Locations

Locations (2)

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain