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

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ClinicalTrials.gov Identifier: NCT00529932
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : September 14, 2007
Last Update Posted : April 22, 2015
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Jozef Bartunek, Onze Lieve Vrouw Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2007
First Posted Date  ICMJE September 14, 2007
Last Update Posted Date April 22, 2015
Study Start Date  ICMJE September 2007
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2007)
  • 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. [ Time Frame: 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. [ Time Frame: at 6 and 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00529932 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2007)
  • SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: prior to the infusion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
Official Title  ICMJE A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • Other: CD133+ infusion
    Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).
  • Other: placebo infusion
    Buffered normal saline will be infused in the coronary artery during an angiography.
Study Arms  ICMJE
  • Active Comparator: 1
    Enriched CD133+, bone marrow-derived, autologous progenitor cells for this trial will be infused in the coronary arteries
    Intervention: Other: CD133+ infusion
  • Placebo Comparator: 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.
    Intervention: Other: placebo infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 21, 2015)
19
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2007)
60
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Netherlands,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00529932
Other Study ID Numbers  ICMJE SELECT-AMI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jozef Bartunek, Onze Lieve Vrouw Hospital
Study Sponsor  ICMJE Jozef Bartunek
Collaborators  ICMJE King's College London
Investigators  ICMJE
Study Chair: Jozef Bartunek, MD OLVZ Aalst
Study Chair: Jonathan Hill, MD King's College London
PRS Account Onze Lieve Vrouw Hospital
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP