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

Phase II, Blind, Controlled, Randomised Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00908622

Acronym

PERCUTANEO

Enrollment

Registered

2009-05-27

Start date

2007-03-31

Completion date

2012-06-30

Last updated

2015-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Old Myocardial Infarction

Keywords

Percutaneous implantation of autologous myoblasts

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.

Interventions

PROCEDUREPercutaneous autologous myoblast implantation

Endocavity implantation of autologous myoblasts

PROCEDURECardiac revascularization

Cardiac revascularization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Ejection fraction measured with echocardiography in the ITT population	12 month after surgery

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026