Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350766
Status:
TERMINATED
Last Update Posted:
2017-03-30
First Post:
2006-07-10
Brief Title:
Cell Therapy in Myocardial Infarction
Sponsor:
Ministry of Health Brazil
Organization:
Ministry of Health Brazil
Study Overview
Official Title:
Multicenter Prospective Randomized Double Blind Trial of Bone Marrow Mononuclear Cells Transplantation Through Intracoronary Injection in Patients With Acute Myocardial Infarction
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment rate and consequent financial exhaustion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMRTCC
Brief Summary:
The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction STEMI
Detailed Description:
This study protocol describes a randomized double blind clinical trial which main purpose is to evaluate the effect of the autologous bone marrow mononuclear cell ABMMC implant in 300 Brazilian patients with ST elevation acute myocardial infarction STEMI
Double blind study design was chosen for this trial based on several phase I and II safety trials of intracoronary autologous bone marrow stem cells transplantation already published The study coordinator committee supported by the Brazilian Health Ministry therefore has proposed a phase III trial with the purpose of proving the efficacy of this kind of therapy for a population with a high risk of developing heart failure and of death by cardiovascular cause
Thus in this protocol we propose a prospective double blind controlled and randomized trial to evaluate the effect of ABMMC transplantation through intracoronary infusion on systolic left ventricle LV function The main hypothesis of this trial is that patients submitted to autologous bone marrow stem cell implant after 6 months follow up will present a 5 relative increase of the ejection fraction EF comparing to control group
Double blind study design was chosen for this trial based on several phase I and II safety trials of intracoronary autologous bone marrow stem cells transplantation already published The study coordinator committee supported by the Brazilian Health Ministry therefore has proposed a phase III trial with the purpose of proving the efficacy of this kind of therapy for a population with a high risk of developing heart failure and of death by cardiovascular cause
Thus in this protocol we propose a prospective double blind controlled and randomized trial to evaluate the effect of ABMMC transplantation through intracoronary infusion on systolic left ventricle LV function The main hypothesis of this trial is that patients submitted to autologous bone marrow stem cell implant after 6 months follow up will present a 5 relative increase of the ejection fraction EF comparing to control group
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