A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction (SELECT-AMI)

Jozef Bartunek

Status: Terminated

Conditions: Acute Myocardial Infarction

Treatments: Other: placebo infusion; Other: CD133+ infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00529932

SELECT-AMI

Details and patient eligibility

About

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).

Enrollment: 19 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

19 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Enriched CD133+, bone marrow-derived, autologous progenitor cells for this trial will be infused in the coronary arteries

Treatment:

Other: CD133+ infusion

2

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo infusion