Treatment With Autologous Skeletal Myoblasts

Old Myocardial Infarction Clinical Trial

Official title:

Phase II, Randomised, Controlled Study of Treatment With Revascularisation Surgery With or Without Injection of Autologous Skeletal Myoblasts in Patients With Old Myocardial Infarction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00975234
• Other study ID #: Mio/Reg/Quirur/Aleatorizado
• Status: Terminated
• Phase: Phase 2
• First received: September 10, 2009
• Last updated: June 7, 2012
• Start date: May 2009
• Est. completion date: January 2010

Study information

• Verified date: June 2012
• 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 to determine the benefit of autologous skeletal myoblast injection in patients with old myocardial infarction and ventricular dysfunction versus conventional revascularisation therapy.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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.

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:
• Intra-lesion injection of autologous skeletal myoblasts
Intra-lesion injection
• Revascularisation
Revascularisation surgery

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital Clínico Universitario de Salamanca	Salamanca
Spain	Hospital Clínico Universitario de Santiago	Santiago de Compostela	Galicia
Spain	Hospital La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Fina Biotech

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoints will be evaluate the ejection fraction and wall motion score index measured by M-mode and echocardiography 12 months after surgery.		12 months after surgery	No
Secondary	Secondary efficacy endpoints are viability, perfusion and thickening and incidence of cardiac arrhythmias.		12 month after surgery	Yes