Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-30 @ 1:31 PM
Study NCT ID:
NCT00975234
Status:
TERMINATED
Last Update Posted:
2012-06-08
First Post:
2009-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment With Autologous Skeletal Myoblasts
Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: