An interventional study of CD133+ infusion and placebo infusion in Acute Myocardial Infarction, sponsored by Jozef Bartunek. Terminated at 5 sites in 4 countries. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-22.
Sponsored by Jozef Bartunek · Not applicable, Interventional, and Treatment
An international, multi-centre, double-blind, randomised, placebo-controlled clinical trial with central core lab analyses to determine the safety of intra-coronary infusion of enriched CD133+, bone marrow-derived, autologous progenitor cells in patients 5-10 days after acute percutaneous coronary revascularization (primary PCI) for ST-segment elevation myocardial infarction (STEMI).
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 19 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →This is the only study on the registry with Jozef Bartunek as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enriched CD133+, bone marrow-derived, autologous progenitor cells for this trial will be infused in the coronary arteries
Other: CD133+ infusion
Control group patients will receive 3 injections of 0.3 mL each of buffered normal saline (the vehicle used for cell suspension) into comparable vessels. Subjects will have an identical intra-coronary injection procedure to those randomized to autologous CD133+ progenitor cell injections.
Other: placebo infusion
Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).
Buffered normal saline will be infused in the coronary artery during an angiography.
PRIMARY SAFETY ENDPOINT Comparison of progression in coronary atherosclerosis burden proximal and distal to the stented segment of the infarct-related artery in treated and control groups.
Time frame: at 6 months post-infusion
PRIMARY EFFICACY ENDPOINT Comparison of changes in myocardial thickening in non-viable akinetic / hypokinetic LV wall segments as determined by cardiac magnetic resonance imaging (cMRI) in treated and control groups.
Time frame: at 6 and 24 months
SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure.
Time frame: At all follow up's
SECONDARY EFFICACY ENDPOINTS (a) Changes in % global LV ejection fraction (EF) compared with baseline as determined by cMRI and echocardiography pre- and post-cell infusion subsequent to primary PCI.
Time frame: at all follow up's
SECONDARY EFFICACY ENDPOINTS (b)Assessment of epicardial resistance and microvascular resistance, index of myocardial resistance and absolute coronary blood flow measurements in the infarct related artery.
Time frame: at 6 months follow up
SECONDARY EFFICACY ENDPOINTS (c) The feasibility of the CliniMACS® Reagent System to yield 5x106 CD133+ cells from 100-150 ml of autologous bone marrow.
Time frame: prior to the infusion
This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.