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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Acute Myocardial Infarction
Unfortunately contact details are not available for this trial.
Primary Contact Details
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).
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Other : CD133+ infusion, Other : placebo infusion

Study Arm Groups : 1, 2

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
20 Years - 75 Years
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
Trial Location(s)
London
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Belgium, France, Netherlands, United Kingdom
Scientific Title
A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
EudraCT Number
Not available for this trial
Funder(s)
  • King's College London
Other Study ID Numbers
SELECT-AMI
Sponsor(s)
Jozef Bartunek
Key Dates

Recruitment Start Date

Sep 2007

Recruitment End Date

Dec 2011

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

13 Sep 2007

Last Updated

21 Apr 2015