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Sponsors and Collaborators: |
Minneapolis Heart Institute Foundation Abbott Northwestern Hospital |
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Information provided by: | Minneapolis Heart Institute Foundation |
ClinicalTrials.gov Identifier: | NCT00268307 |
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.
Condition | Intervention | Phase |
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Acute Myocardial Infarction |
Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Cellular Transplantation of Autologous Bone Marrow-Derived Stem Cells Following Myocardial Infarction |
Estimated Enrollment: | 60 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jay Traverse, MD | 612.863.3900 | trave004@umn.edu |
Contact: Beth C Jorgenson, MA, RN | 612.863.7485 | beth.jorgenson@allina.com |
United States, Minnesota | |
Minneapolis Heart Institute Foundation | Recruiting |
Minneapolis, Minnesota, United States, 55407 | |
Principal Investigator: Jay Traverse, MD |
Principal Investigator: | Jay Traverse, MD | Minneapolis Heart Institute |
Responsible Party: | Minneapolis Heart Institute ( Jay Traverse, MD ) |
Study ID Numbers: | opt001 |
Study First Received: | December 20, 2005 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00268307 |
Health Authority: | United States: Food and Drug Administration |
Cell therapy |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |