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| Name | Class |
|---|---|
| Allina Health System | OTHER |
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The goal of this study is to determine the safety of giving a patient's own bone marrow-derived stem cells delivered with a catheter (tube) into the coronary arteries (blood vessels of the heart). Stem cells are simple cells produced by the bone marrow that can develop into many types of cells. It is possible that these cells will decrease the size of damage caused to the heart from a heart attack and increase the pumping efficiency of the heart; which can be decreased due to a heart attack. The stem cells will be taken from bone marrow and then given back into the heart vessels.
This protocol will test the hypothesis that an intracoronary infusion of autologous, unfractionated, bone marrow mononuclear cells will attenuate infarct size and improve left-ventricular function in 60 patients following an acute anterior myocardial infarction who have undergone successful revascularization with PTCA/stenting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell therapy | Experimental | Intracoronary, one time infusion of autologous, unfractionated bone marrow mononuclear cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous, Unfractionated Bone Marrow Mononuclear Cells | Drug | Intracoronary infusion of Autologous, Unfractionated Bone Marrow Mononuclear Cells. Dose is 100,000,000 cells. One time infusion over 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by holter monitor, laboratory assessments, and cardiac MRI | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of left ventricular function as assessed by serial measurements of infarct size and LV function by cardiac MRI in the active treatment group versus placebo. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Traverse, MD | Minneapolis Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20826249 | Result | Traverse JH, McKenna DH, Harvey K, Jorgenso BC, Olson RE, Bostrom N, Kadidlo D, Lesser JR, Jagadeesan V, Garberich R, Henry TD. Results of a phase 1, randomized, double-blind, placebo-controlled trial of bone marrow mononuclear stem cell administration in patients following ST-elevation myocardial infarction. Am Heart J. 2010 Sep;160(3):428-34. doi: 10.1016/j.ahj.2010.06.009. |
| Label | URL |
|---|---|
| click here for more information on this study | View source |
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