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.

Study design

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.

Inclusion criteria

Participant may enter study if ALL of the following apply:

• Previous anterior 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.

Exclusion criteria

Participant may not enter study if ANY of the following apply:

• Severe acute renal failure requiring dialysis or serum creatinine ≥200 mmol/L;
• Malignancy;
• 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.

Principal investigators

Ascione R, Guttridge M, Hamilton M, Reeves BC, Angelini GD

If you require any help, please contact:

Dr Jodi Taylor
Email: j.taylor@bristol.ac.uk
Tel: 0117 928 3398

Randomisation service provided by: Sealed Envelope™.com