Photo courtesy of euthman
The aim of this study is to determine the effects of CD133+ autologous stem cell
transplantation in and around asynergic non viable LV segments in patients with dilated
ischaemic heart disease undergoing left ventricular reshaping surgery and CABG.
The study is a single centre, randomised-controlled clinical trial in patients
undergoing left ventricular restoration surgery for dilated ischemic end-stage
heart failure. Participants and all members of the healthcare and research team
are blinded to the study allocation.
Eligible patients undergoing SVR surgery will be allocated to either:
- Intervention group: SVR surgery and transplantation of autologous CD133+;
- Control group: SVR surgery and 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.
Participant may enter study if ALL of the following apply:
- Previous myocardial infarction (with evidence of large surgically
excludible scar at cardiac MRI);
- Significant LV dilation (left ventricular end-systolic volume index [LVESVI] ≥80 ml/m2
and left ventricular ejection fraction ≤35%);
- NYHA class III/IV and one episode of CHF requiring medical attention;
- Elective left ventricular restoration surgery indicated;
- Patient aged 16 years or over and under 80 years old.
Participant may not enter study if ANY of the following apply:
- Severe acute renal failure requiring dialysis or serum creatinine ≥200 mmol/L;
- Debilitating neurological disease;
- Emergency operation for unstable angina;
- Previous cardiac surgery/sternotomy;
- Concomitant valve procedures;
- History of significant ventricular arrhythmias;
- History of pace-maker and/or defibrillator insertion;
- Right ventricular (RV) failure;
- Pulmonary hypertension >60 mm Hg (angiogram or Elixis)
- Known active infection;
- Chronic inflammatory disease;
- Contraindication for bone marrow aspiration;
- Female subjects of childbearing potential.
Ascione R, Guttridge M, Hamilton M, Reeves BC, Angelini GD