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

NCT ID: NCT00529932

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-12-31

Brief Summary

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).

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

CD133+ infusion

Intervention Type: OTHER

Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).

2

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.

Group Type: PLACEBO_COMPARATOR

placebo infusion

Intervention Type: OTHER

Buffered normal saline will be infused in the coronary artery during an angiography.

Interventions

CD133+ infusion

Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).

Intervention Type: OTHER

placebo infusion

Buffered normal saline will be infused in the coronary artery during an angiography.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Jozef Bartunek

OTHER

Sponsor Role: lead

Responsible Party

Jozef Bartunek

Jozef Bartunek

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jozef Bartunek, MD

Role: STUDY_CHAIR

OLVZ Aalst

Jonathan Hill, MD

Role: STUDY_CHAIR

King's College London

Locations

OLVZ Aalst

Aalst, , Belgium

CHU ST-Pierre

Brussels, , Belgium

Hôpital Cardiologique

Lille, , France

Catharina Ziekenhuis

Eindhoven, , Netherlands

King's College University Hospital

London, , United Kingdom

Countries

Belgium; France; Netherlands; United Kingdom

Other Identifiers

SELECT-AMI

Identifier Type: -

Identifier Source: org_study_id