None listed
Conditions
Brief summary
Our proposed research protocol involves patients presenting an acute myocardial infarction with left ventricular dysfunction. It is a phase II, prospective, randomized, 2 arms, double-blind, placebo-controlled clinical trial recruiting 40 patients to test the safety, feasibility and the functional effect of the intracoronary administration of a selected population of Autologous bone marrow CD133+ cells as compared to placebo. Following a successful primary or rescue percutaneous intervention (PCI) for an acute myocardial infarct (MI), patients are eligible for inclusion in this study if the following criteria are fulfilled: age between 30 and 75 years, chest pain for more than 30 minutes and less than 24 hours, ST segment elevation >1 mm in 2 consecutive leads in the limb leads or >2 mm in the precordial leads and an increase in CK or CKMB. Patients need to be < 7 days of admission for their acute ST elevation myocardial infarction, have successful stenting of the culprit stenosis with a normal thrombolysis in myocardial infarction (TIMI) flow, a reference lumen >3mm, single vessel disease, an LVEF <50 and >25%, regional wall motion abnormalities (moderate to severe hypokinesia, akinesia, dyskinesia) in at least 2 adjacent segments on the resting Echocardiography obtained within 48 hours after the acute event, clinically and hemodynamically stable over the last 12 hours. A total of 40 patients in the participating center will be recruited.
Interventions
Early in the morning, bone marrow harvest under local analgesia, up to 100 ml, this takes approximately 60 minutes. Cell processing in the CEll therapy laboratory: CD133+ stem cells purification using the CliniMACS system from Miltenyi Biotech Inc. Later in the same day, and withing 24hrs from bone marrow harvest: intracoronary injection of autologous CD133+ selected stem cells, up to 10 millions cells. This procedure requires percutaneous intervention, requires approximately 60 to 90 minutes.
Sponsors
Miltenyi Biotech Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
acute ST-elevation myocardial infarct successfully reperfused by means of coronary stent implantation and demonstrated a substantial persistent LV dysfunction defined by a LVEF <50% but >25% on echocardiography obtained within 48 hours after the successful reperfusion therapy.
Exclusion criteria
known previous myocardial infarct, cardiogenic shock, chronic cardiomyopathy, liver disease, renal failure, concomitant disease with a life expectancy of less than 1 year, alcohol or drug dependency, contraindication for bone marrow (BM) aspiration, blood transfusion in the previous 24 hours, hematopoietic disease, chronic inflammatory disease, malignancy, stroke in the previous 3 months or transient ischemic attack in the previous 24 hours.
Outcome results
None listed