Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2026-04-04 @ 12:09 PM
Study NCT ID:
NCT00480961
Status:
UNKNOWN
Last Update Posted:
2007-06-01
First Post:
2007-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy
Sponsor:
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischemic etiology. Cellular implantation will take place during off-pump revascularization surgery or during an ad hoc procedure using a mini-thoracotomy access.
Detailed Description:
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients. Secondary target: determine clinical effects of grafted cells on remodeling pathology.
Study Oversight
Has Oversight DMC:
True
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?: