A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction | Stopped
A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
SELECT-AMI
Trial Source

Health Conditions
  • Acute Myocardial Infarction
Stopped
Recruitment Status
NCT00529932
Primary Trial ID Number
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).
Primary Outcome Measures
  • 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 Outcome Measures
  • 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
Research Question
  • 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).
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
Belgium; France; Netherlands; United Kingdom
Participant Sex
Both
Participant Age Range
20 Years to 75 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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.
Participant Exclusion 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.
Interventions
Other; CD133+ infusion; Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).; [1]; Other; placebo infusion; Buffered normal saline will be infused in the coronary artery during an angiography.; [2]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
SELECT-AMI
Scientific Title
A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
Secondary Trial Identifying Number
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Website
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Study Funded By
Jozef Bartunek
Funder Type
Sorry, this information is not available
Study Sponsored By
Jozef Bartunek
Study Also Sponsored By
King's College London
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

13 Sep 2007

Last Updated

21 Apr 2015

Date Record Refreshed on UKCTG

31 Jul 2015