Bone Marrow Stem Cell Infusion Following a Heart Attack

Minneapolis Heart Institute Foundation

Status and phase

Completed

Phase 1

Conditions

Acute Myocardial Infarction

Treatments

Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT00268307

opt001

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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