Coronary Artery Disease Clinical Trial
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)
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 hematopoietic,)to 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 CD34+cell infusion.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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