Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00313339
Status:
COMPLETED
Last Update Posted:
2013-11-18
First Post:
2006-04-10
Brief Title:
Intra-coronary Infusion of Bone Marrow Derived Autologous CD34 Selected Cells in Patients With Acute Myocardial Infarction
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
AMORCYTE MYOCARDIAL REPAIR STUDY- A Phase I Trial of Intra-coronary Infusion of Bone Marrow Derived Autologous CD34 Selected Cells in Patients With Acute Myocardial Infarction AMRS
Status:
COMPLETED
Status Verified Date:
2013-11
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:
AMR-1
Brief Summary:
Following a Heart attack the acute loss of heart muscle cells results in a cascade of events causing an immediate decrease in cardiac function that has the potential to persist long term Despite revascularization of the infarct related artery circulation and appropriate medical management to minimize the stresses on the heart walls a significant percentage of patients experience permanent cardiac dysfunction and consequently remain at an increased life-time risk of experiencing adverse cardiac events including death
There is a great potential for stem cell therapy using a variety of cell precursors particularly hematopoieticto contribute to new blood vessel formation and possibly limited heart muscle formation and muscle preservation in the myocardial infarct zone The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies
Therefore we propose to evaluate the safety and efficacy of a CD34 selected stem cell product AMR-001 administered through the infarct related coronary artery 6 to 9 days after successful infarct related artery stent placement
The primary objective of the study is to determine the feasibility and safety of prospectively identifying patients at risk for clinically significant cardiac dysfunction following a myocardial infarction and the ability to isolate and infuse via the affected coronary circulation an autologous bone marrow derived CD34 cell product at four dose levels
The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion A concurrent patient group meeting eligibility but not receiving CD34 cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function without CD34cell infusion
There is a great potential for stem cell therapy using a variety of cell precursors particularly hematopoieticto contribute to new blood vessel formation and possibly limited heart muscle formation and muscle preservation in the myocardial infarct zone The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies
Therefore we propose to evaluate the safety and efficacy of a CD34 selected stem cell product AMR-001 administered through the infarct related coronary artery 6 to 9 days after successful infarct related artery stent placement
The primary objective of the study is to determine the feasibility and safety of prospectively identifying patients at risk for clinically significant cardiac dysfunction following a myocardial infarction and the ability to isolate and infuse via the affected coronary circulation an autologous bone marrow derived CD34 cell product at four dose levels
The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion A concurrent patient group meeting eligibility but not receiving CD34 cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function without CD34cell infusion
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FDA IND 12584 | None | None | None |