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

NCT00529932 | Terminated DMC

• 1 other identifier: SELECT-AMI
• Study Type: interventional
• Target: 19
• Locations: 4 countries
• Sites: 5

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

Keywords

Acute Myocardial Infarction; Celltherapy; Bone Marrow

Outcome Measures

Primary Outcomes (2)

• PRIMARY SAFETY ENDPOINT Comparison of progression in coronary atherosclerosis burden proximal and distal to the stented segment of the infarct-related artery in treated and control groups.

  at 6 months post-infusion

• PRIMARY EFFICACY ENDPOINT Comparison of changes in myocardial thickening in non-viable akinetic / hypokinetic LV wall segments as determined by cardiac magnetic resonance imaging (cMRI) in treated and control groups.

  at 6 and 24 months

Secondary Outcomes (4)

• SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure.

  At all follow up's

• SECONDARY EFFICACY ENDPOINTS (a) Changes in % global LV ejection fraction (EF) compared with baseline as determined by cMRI and echocardiography pre- and post-cell infusion subsequent to primary PCI.

  at all follow up's

• SECONDARY EFFICACY ENDPOINTS (b)Assessment of epicardial resistance and microvascular resistance, index of myocardial resistance and absolute coronary blood flow measurements in the infarct related artery.

  at 6 months follow up

• SECONDARY EFFICACY ENDPOINTS (c) The feasibility of the CliniMACS® Reagent System to yield 5x106 CD133+ cells from 100-150 ml of autologous bone marrow.

  prior to the infusion

Study Arms (2)

1

ACTIVE COMPARATOR

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

Other: CD133+ infusion

2

PLACEBO COMPARATOR

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.

Other: placebo infusion

Interventions

CD133+ infusion OTHER

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

1

placebo infusion OTHER

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

2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jozef Bartunek: lead
• King's College London: collaborator

Study Sites (5)

OLVZ Aalst

Aalst, 9400, Belgium

Location

CHU ST-Pierre

Brussels, Belgium

Location

Hôpital Cardiologique

Lille, France

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

King's College University Hospital

London, United Kingdom

Location

Study Officials

• Jozef Bartunek, MD

  OLVZ Aalst

  STUDY CHAIR

• Jonathan Hill, MD

  King's College London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Jozef Bartunek

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 14, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

FR (1); GB (1); BE (2); NL (1)