Not provided
Not provided
Not provided
Not provided
Insufficient recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| King's College London | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Enriched CD133+, bone marrow-derived, autologous progenitor cells for this trial will be infused in the coronary arteries |
|
| 2 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD133+ infusion | Other | Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | at 6 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jozef Bartunek, MD | OLVZ Aalst | Study Chair |
| Jonathan Hill, MD | King's College London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVZ Aalst | Aalst | 9400 | Belgium | |||
| CHU ST-Pierre |
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo infusion | Other | Buffered normal saline will be infused in the coronary artery during an angiography. |
|
| 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. | 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. | prior to the infusion |
| Brussels |
| Belgium |
| HĂ´pital Cardiologique | Lille | France |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| King's College University Hospital | London | United Kingdom |