Viewing Study NCT00260338



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Last Modification Date: 2024-10-26 @ 9:21 AM
Study NCT ID: NCT00260338
Status: COMPLETED
Last Update Posted: 2013-05-31
First Post: 2005-11-29

Brief Title: Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
Sponsor: Rigshospitalet Denmark
Organization: Rigshospitalet Denmark

Study Overview

Official Title: Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
Status: COMPLETED
Status Verified Date: 2013-05
Last Known Status: None
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: Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue

The aim of the study is in a phase III safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia
Detailed Description: Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue

The aim of the study is in a phase III safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia

4o patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cellsClinical and objective evaluations will be performed at baseline and during 12 months follow-up

Study Oversight

Has Oversight DMC: None
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?: None