Clinical trial NCT00908622: Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction
Official title: Phase II, Blind, Controlled, Randomised Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Old Myocardial Infarction
Keywords: Percutaneous implantation of autologous myoblasts
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Finabiotech
First posted: 2009-05-27
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ejection fraction and wall motion score index measured with M-mode and echocardiography
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population
timeFrame: 12 month after surgery
measure: Viability measured with echocardigraphy and magnetic resonance in the ITT population
timeFrame: 12 month after surgery
measure: Incidence of cardiac arrythmias in the ITT population
timeFrame: 12 month after surgery
measure: Ejection fraction measured with echocardiography in the ITT population
timeFrame: 12 month after surgery
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
Study officials:
affiliation: Clínica Universidad de Navarra
name: Felipe Prósper, MD, Ph.D.
role: STUDY_DIRECTOR
References: