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

Acute Myocardial Infarction Clinical Trial

— SELECT-AMI  

Official title:

A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00529932
• Other study ID #: SELECT-AMI
• Status: Terminated
• Phase: N/A
• First received: September 13, 2007
• Last updated: April 21, 2015
• Start date: September 2007
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: Onze Lieve Vrouw Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Other:
• CD133+ infusion
Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).
• placebo infusion
Buffered normal saline will be infused in the coronary artery during an angiography.

Locations

Country	Name	City	State
Belgium	OLVZ Aalst	Aalst
Belgium	CHU ST-Pierre	Brussels
France	Hôpital Cardiologique	Lille
Netherlands	Catharina Ziekenhuis	Eindhoven
United Kingdom	King's College University Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Jozef Bartunek	King's College London

Countries where clinical trial is conducted

Belgium,  France,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure.		At all follow up's	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No