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Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction (AMR-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00313339
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : November 18, 2013
Texas Heart Institute
Information provided by (Responsible Party):
Arshed A. Quyyumi, Emory University

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 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Coronary Artery Disease Drug: Intra-coronary infusion Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : March 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
No Intervention: 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.
Experimental: Treatment Group
Intra-coronary infusion of an autologous bone marrow derived CD34+ stem cell product.
Drug: Intra-coronary infusion
In our study there will be four dosing cohorts (5, 10, 20 and 30 x 106) of CD34+ cells.

Primary Outcome Measures :
  1. Cardiac function at 3 and 6 months follow-up will be compared to baseline measures obtained the day(s) before CD34+ cell product infusion. [ Time Frame: 3 & 6 Months ]

Secondary Outcome Measures :
  1. Perfusion of the infarct region at 6 months follow-up will be compared to baseline measures obtained the day(s) before CD34+ cell product infusion [ Time Frame: 6 Months ]
  2. An assessment will be performed to determine if a correlation exist between clinical outcome and cell content (CD34+) and/or in vitro colony growth (CFU-GM, CFU-GEMM, BFU-E) CXCR-4 mobility and CXCR-4 and/or VEGF surface antigen expression. [ Time Frame: Baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 - 75 years.
  • 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:

  • Patients who are not candidates for percutaneous intervention, conscious sedation, MRI, SPECT imaging or mini-bone marrow harvest
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00313339

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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30326
Sponsors and Collaborators
Emory University
Texas Heart Institute
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Principal Investigator: ARSHED A QUYYUMI, MD Emory University
Publications of Results:
Other Publications:
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Responsible Party: Arshed A. Quyyumi, Professor, Emory University Identifier: NCT00313339    
Other Study ID Numbers: 0076-2006
FDA IND 12584
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: November 18, 2013
Last Verified: November 2013
Keywords provided by Arshed A. Quyyumi, Emory University:
myocardial infarction
bone marrow
stem cells
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases