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Bone Marrow Stem Cell Infusion Following a Heart Attack

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: NCT00268307
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : December 5, 2013
Allina Health System
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells Phase 1

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cellular Transplantation of Autologous Bone Marrow-Derived Stem Cells Following Myocardial Infarction
Study Start Date : December 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Cell therapy
Intracoronary, one time infusion of autologous, unfractionated bone marrow mononuclear cells.
Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells
Intracoronary infusion of Autologous, Unfractionated Bone Marrow Mononuclear Cells. Dose is 100,000,000 cells. One time infusion over 20 minutes.

Primary Outcome Measures :
  1. Safety as measured by holter monitor, laboratory assessments, and cardiac MRI [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients age at least 21 years of age
  • Patients with an acute anterior myocardial infarction limited to the proximal or mid-LAD with an artery diameter of at least 2.5 mm.
  • Ability to undergo cell therapy procedure within 2 to 7 days following acute MI and PTCA/stenting.
  • Ejection fraction following reperfusion with PTCA/stenting is between 30% and 50% as assessed by left-ventriculography or echocardiography.
  • Consent to protocol and agree to comply with all follow-up visits and studies.

Exclusion Criteria:

  • History of sustained ventricular arrhythmias not related to their acute myocardial infarction who do not have an ICD.
  • Require coronary artery bypass surgery or percutaneous revascularization due to the presence of residual coronary stenosis > 70% luminal obstruction in the non-infarct related vessel.
  • History of malignancy within the past 5 years excluding non-melanoma skin cancer or cervical cancer in-situ.
  • History of anemia (Hb < 9.0 mg/dl).
  • History of thrombocytosis.
  • PT or PTT greater than the upper limits of normal.
  • Life expectancy less than one year.
  • Patients on chronic dialysis.
  • History of untreated alcohol or drug abuse.
  • Currently enrolled in another Investigational drug or device trial.
  • History of stroke or TIA within the past 6 months.
  • History of severe valvular heart disease (aortic valve area < 1.0 cm2 or > 3+ mitral regurgitation.
  • Pregnancy
  • Subjects who are HIV, hepatitis B or C positive.
  • Patients with active inflammatory or autoimmune disease on chronic immunosuppressive therapy.
  • Contraindications to cardiac MRI

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): NCT00268307

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United States, Minnesota
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Allina Health System
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Principal Investigator: Jay Traverse, MD Minneapolis Heart Institute

Additional Information:
Publications of Results:
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Responsible Party: Minneapolis Heart Institute Foundation Identifier: NCT00268307     History of Changes
Other Study ID Numbers: opt001
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: December 2013
Keywords provided by Minneapolis Heart Institute Foundation:
Cell therapy
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases