Clinical trial NCT00268307: Bone Marrow Stem Cell Infusion Following a Heart Attack
Official title: Cellular Transplantation of Autologous Bone Marrow-Derived Stem Cells Following Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myocardial Infarction
Keywords: Cell therapy
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
Collaborators: name: Allina Health System
First posted: 2005-12-22
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety as measured by holter monitor, laboratory assessments, and cardiac MRI
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
Study officials:
affiliation: Minneapolis Heart Institute
name: Jay Traverse, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.