Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00400959
Status:
COMPLETED
Last Update Posted:
2006-11-17
First Post:
2006-11-14
Brief Title:
CD133 Autologous Cells After Myocardial Infarction
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Intracoronary Injection of CD133 Autologous Hematopoietic Cells After Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2006-11
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:
TITLE Intracoronary injection of CD133 autologous hematopoietic cells after myocardial infarction
TRIAL DESIGN Pilot phase III parallel group study with an untreated control group
SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction AMI TARGET POPULATION Patients pts with AMI treated with Primary Coronary Angioplasty PTCA with successful recanalization but unsuccessful reperfusion myocardial blush MB grade 0 or 1 and less than 70 ST segment elevation resolution STeR see Poli et al Circulation 2002
OBJECTIVES Primary
1 To evaluate the safety of intracoronary injection of CD133 cells from autologous bone marrow ABM and mobilized peripheral blood MPB in the target population
2 To evaluate the efficacy of the selective injection of CD133 cells from ABM and MPB in the culprit vessel of the target population on regional and global contractile function and on perfusion and metabolism of the infarcted area depending on cell dose and comparing to controls
Secondary
3 To evaluate the disease-related morbility of the target population
TRIAL DESIGN Pilot phase III parallel group study with an untreated control group
SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction AMI TARGET POPULATION Patients pts with AMI treated with Primary Coronary Angioplasty PTCA with successful recanalization but unsuccessful reperfusion myocardial blush MB grade 0 or 1 and less than 70 ST segment elevation resolution STeR see Poli et al Circulation 2002
OBJECTIVES Primary
1 To evaluate the safety of intracoronary injection of CD133 cells from autologous bone marrow ABM and mobilized peripheral blood MPB in the target population
2 To evaluate the efficacy of the selective injection of CD133 cells from ABM and MPB in the culprit vessel of the target population on regional and global contractile function and on perfusion and metabolism of the infarcted area depending on cell dose and comparing to controls
Secondary
3 To evaluate the disease-related morbility of the target population
Detailed Description:
None
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