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The objective of this study is to compare subepicardial injection of enriched autologous CD 133 cells derived from bone marrow into infarcted myocardium with injection of placebo in patients having CABG following a recent STEMI. The primary outcome measure is the extent of change in regional wall thickening.
Study design
We propose a double-blind, randomised placebo controlled clinical trial in patients undergoing coronary surgery following a recent anterior STEMI. The trial will compare:
- Experimental intervention: injection of enriched autologous CD 133 stem cells derived from bone marrow, suspended in autologous plasma;
- Control intervention: injection of placebo, i.e. autologous plasma.
Patients will be assigned to the intervention or control group in a 1:1 ratio using blocked randomisation.
Inclusion criteria
- Recent (>10 days and <3 months) anterior STEMI who have not undergone primary angioplasty;
- Cardiac MRI documented anterior MI with a transmurality of ≥50% wall thickness in at least 1 segment of the LAD territory;
- Requirement for CABG alone to bypass stenoses or occlusions of the LAD territory and any other territory as dictated by baseline coronary angiography;
- Absence of LV dilatation (LV end systolic volume index <60 ml/m2);
- Patient aged 16 years or over and under 80 years old.
Exclusion criteria
- Presence of cardiogenic shock or presence of acute left and/or right-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema;
- Cardiac MRI documented MI transmurality of <50% wall thickness in all 7 segments of the LAD territory;
- Presence of LV dilatation (LV end systolic volume index >60 ml/m2) or ejection fraction <25%;
- Cardiomyopathy secondary to a reversible cause;
- Known active infection;
- Chronic inflammatory disease;
- Serum creatinine ≥200 mmol/L;
- Contraindication for bone marrow aspiration;
- Female subjects of childbearing potential;
- Emergency operation for unstable angina;
- History of pace-maker or defibrillator insertion;
- Undergoing other surgical procedure (cardiac or thoracic).
Principal investigators
- Ascione R
- Guttridge M
- Kenning-Kendall P
- Wilde P
- Reeves BC
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