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

Old Myocardial Infarction Clinical Trial

— PERCUTANEO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00908622
• Other study ID #: MIO/REG/PERCUTÁNEO
• Status: Terminated
• Phase: Phase 2
• First received: May 25, 2009
• Last updated: September 10, 2015
• Start date: March 2007
• Est. completion date: June 2012

Study information

• Verified date: September 2015
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Old Myocardial Infarction

Intervention

Procedure:
• Percutaneous autologous myoblast implantation
Endocavity implantation of autologous myoblasts
• Cardiac revascularization
Cardiac revascularization

Locations

Country	Name	City	State
Spain	Hospital Gregorio Marañón	Madrid
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Finabiotech

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ejection fraction and wall motion score index measured with M-mode and echocardiography		12 months after surgery	No
Secondary	Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population		12 month after surgery	Yes
Secondary	Viability measured with echocardigraphy and magnetic resonance in the ITT population		12 month after surgery	No
Secondary	Incidence of cardiac arrythmias in the ITT population		12 month after surgery	No
Secondary	Ejection fraction measured with echocardiography in the ITT population		12 month after surgery	No