Intracoronary infusion of autologous mononuclear bone marrow cells or peripheral mononuclear blood cells after primary percutaneous coronary intervention: rationale and design of the HEBE trial--a prospective, multicenter, randomized trial.

BACKGROUND: Recently, several preliminary reports have demonstrated that cell transplantation after acute myocardial infarction in humans is safe and leads to better preserved left ventricular function and improved myocardial perfusion and coronary flow reserve.

METHODS: The HEBE trial is a multicenter, prospective, randomized, 3-arm open trial with blinded evaluation of end points. Patients with acute large myocardial infarction treated with primary percutaneous coronary intervention (PCI) will undergo magnetic resonance imaging (MRI) and echocardiography. A total of 200 patients are randomized to treatment with (1) intracoronary infusion of autologous mononuclear bone marrow cells, (2) intracoronary infusion of peripheral mononuclear blood cells, or (3) standard therapy. Mononuclear cells are isolated from bone marrow aspirate or venous blood by density gradient centrifugation. Within 7 days after PCI and within 24 hours after bone marrow aspiration or blood collection, a catheterization for intracoronary infusion of the mononuclear cells in the infarct-related artery is performed. In all patients, follow-up will be obtained at 1, 4, and 12 months. MRI and catheterization are repeated at 4 months, and all images are analyzed by a core laboratory blinded to randomization. The primary end point of the study is the change in regional myocardial function in dysfunctional segments at 4 months relative to baseline, based on segmental analysis as measured by MRI.

IMPLICATIONS: If intracoronary infusion of autologous mononuclear bone marrow cells or peripheral mononuclear blood cells is proven to be beneficial after primary PCI; it could be a valuable tool in preventing heart failure-related morbidity and mortality after myocardial infarction.