Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction
NCT ID: NCT00313339
Last Updated: 2013-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2006-03-31
2013-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Control Group
A concurrent group meeting eligibility criteria but not receiving CD34+cells will be evaluated similar to the study group to assess the extent, if any, of significant improvement in cardiac perfusion/function without the CD34+cell product infusion.
No interventions assigned to this group
Treatment Group
Intra-coronary infusion of an autologous bone marrow derived CD34+ stem cell product.
Intra-coronary infusion
In our study there will be four dosing cohorts (5, 10, 20 and 30 x 106) of CD34+ cells.
Interventions
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Intra-coronary infusion
In our study there will be four dosing cohorts (5, 10, 20 and 30 x 106) of CD34+ cells.
Eligibility Criteria
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Inclusion Criteria
* Acute ST elevation myocardial infarction meeting ACC/AHA criteria, with symptoms of chest pain within 3 days of admission. Criteria include (ST elevation \> 1mm in limb leads or 2 mm in two or more precordial leads and increased levels of troponin, CPK MB or both)
* NYHA heart failure class of I, II or III
Exclusion Criteria
* History of sustained chest pain unrelieved by nitrates, occurring 4 or more days before revascularization.
* Patients who fail to re-perfuse the infarct related coronary artery or have successful stent placement
18 Years
75 Years
ALL
No
Sponsors
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Texas Heart Institute
OTHER
Emory University
OTHER
Responsible Party
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Arshed A. Quyyumi
Professor
Principal Investigators
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ARSHED A QUYYUMI, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University
Atlanta, Georgia, United States
Countries
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References
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Quyyumi AA, Waller EK, Murrow J, Esteves F, Galt J, Oshinski J, Lerakis S, Sher S, Vaughan D, Perin E, Willerson J, Kereiakes D, Gersh BJ, Gregory D, Werner A, Moss T, Chan WS, Preti R, Pecora AL. CD34(+) cell infusion after ST elevation myocardial infarction is associated with improved perfusion and is dose dependent. Am Heart J. 2011 Jan;161(1):98-105. doi: 10.1016/j.ahj.2010.09.025.
Murrow J, Esteves F, Galt J, Chen J, Garcia E, Lin J, Lerakis S, Sher S, Khan Pohlel F, Waller EK, Vaughan D, Perin E, Willerson J, Kereiakes D, Preti R, Pecora AL, Quyyumi AA. Characterization of mechanical dyssynchrony measured by gated single photon emission computed tomography phase analysis after acute ST-elevation myocardial infarction. J Nucl Cardiol. 2011 Oct;18(5):912-9. doi: 10.1007/s12350-011-9414-8. Epub 2011 Jun 30.
Other Identifiers
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FDA IND 12584
Identifier Type: -
Identifier Source: secondary_id
0076-2006
Identifier Type: -
Identifier Source: org_study_id