Status:
COMPLETED
Bone Marrow Stem Cell Infusion Following a Heart Attack
Lead Sponsor:
Minneapolis Heart Institute Foundation
Collaborating Sponsors:
Allina Health System
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
21+ years
Phase:
PHASE1
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). Ste...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00268307
Start Date
December 1 2005
End Date
September 1 2010
Last Update
December 5 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407