Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-29 @ 6:38 PM
Study NCT ID:
NCT01666132
Status:
TERMINATED
Last Update Posted:
2015-08-20
First Post:
2011-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease
Sponsor:
Cardiocentro Ticino
Organization:
Study Overview
Official Title:
METHOD - Phase I/II Study of Intramyocardial Injection of Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the slow recruitment process and the progress of newer cell types we decided to stop the trial after the phase 1 (after 10 patients included)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients with chronic ischemic heart disease and LVEF \< 40%. The primary objective is to determine whether the administration of the cells improves recovery of the left ventricular function. Secondary objective is the finding of clinical or paraclinical parameters to predict potential benefits of the treatment (basing on MRI characteristics such as size, transmurality of the myocardial infarction and peri-lesional ischemia).
In the first part of the study 10 patients are treated without control group. This phase serves as feasibility and safety part of the study.
In the first part of the study 10 patients are treated without control group. This phase serves as feasibility and safety part of the study.
Detailed Description:
None
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?: