A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction

A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction

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).

Inclusion Criteria:

• Primary PCI for acute STEMI between 2-24 hours after onset of chest pain.
• ST-segment elevation >=2mm in >=3 adjacent leads.
• Presence of severe hypokinesia and/or akinesia in >=2 adjacent segments on echocardiogram at 48-72 hrs after primary PCI.
• Age between 20 and 75 years.

Exclusion Criteria:

• Pregnant or lactating.
• Prior history of myocardial infarction before index event.
• Decompensated congestive heart failure.
• Pre-existent LV dysfunction (EF <45% prior to admission)
• Cardiomyopathy.
• Previous cardiac surgery.
• Congenital heart disorder.
• Serum creatinine >200 Mmol/L.
• Presence of permanent pacemaker or implantable defibrillator.
• Contraindication to bone marrow aspiration.
• History of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma and/or cervical carcinoma.
• Sustained or inducible VT >48 hours post primary PCI.
• Three vessel coronary artery disease necessitating intervention within 4 months.
• Immune compromise including chronic human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
• Presence of chronic systemic inflammatory disorders.
• Previous autologous or allogeneic bone marrow or peripheral stem cell transplant or prior solid organ transplantation.
• Low hemoglobin, white blood cell, absolute neutrophil and/or platelet count.
• Any condition associated with a life expectancy of less than 6 months.
• Participation in unrelated research involving investigational pharmacological agent(s) 30 days before planned dosing.
• Current alcohol or drug abuse.
• Inability to provide written informed consent.