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A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction (MI-NSTEMI)

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ClinicalTrials.gov Identifier: NCT02277613
Recruitment Status : Recruiting
First Posted : October 29, 2014
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Athersys, Inc

Tracking Information
First Submitted Date  ICMJE October 24, 2014
First Posted Date  ICMJE October 29, 2014
Last Update Posted Date February 5, 2018
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
  • Incidence and severity of adverse events [ Time Frame: 30 days ]
    To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects
  • To assess the effects of AMI MultiStem therapy on cardiac function [ Time Frame: Day 120 ]
    To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
Incidence and severity of adverse events [ Time Frame: 30 days ]
To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects
Change History Complete list of historical versions of study NCT02277613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
  • To assess the effects of AMI MultiStem therapy on cardiac function [ Time Frame: Day 365 ]
    To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects
  • To assess the incidence of Major Adverse Cardiovascular Events (MACE) [ Time Frame: Day 365 ]
    To compare the incidence of MACE between AMI MultiStem therapy treated subjects and Sham treated subjects
  • Incidence and severity of adverse events [ Time Frame: Day 365 ]
    To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • To assess the effects of AMI MultiStem therapy on cardiac function [ Time Frame: Day 120 ]
    To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects
  • To assess the effects of AMI MultiStem therapy on cardiac function [ Time Frame: Day 365 ]
    To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects
  • To assess the incidence of Major Adverse Cardiovascular Events (MACE) [ Time Frame: Day 365 ]
    To compare the incidence of MACE between AMI MultiStem therapy treated subjects and Sham treated subjects
  • Incidence and severity of adverse events [ Time Frame: Day 365 ]
    To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
Official Title  ICMJE A Phase 2 Prospective, Randomized, Double-blind, Sham-controlled, Parallel-group, Multi-center Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
Brief Summary This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Attack
  • NSTEMI
Intervention  ICMJE
  • Biological: AMI MultiStem cells
    AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.
  • Other: Sham
    Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
Study Arms  ICMJE
  • Experimental: AMI MultiStem cells
    AMI MultiStem cells is a cell therapy medicinal product originating from adherent stem cells taken from the bone marrow of a non-related donor and expanded ex vivo.
    Intervention: Biological: AMI MultiStem cells
  • Sham Comparator: Sham
    Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
    Intervention: Other: Sham
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects of either gender, 18-85 years of age, inclusive
  • Diagnosis of non-ST elevation myocardial infarction (NSTEMI)
  • Left Ventricular Ejection Fraction (LVEF) between ≥ 25 and ≤ 45%

Exclusion Criteria:

  • Previous Coronary Artery Bypass Graft (CABG)
  • Previous autologous, allogeneic bone marrow or peripheral stem cell transplant
  • Previous solid organ transplant
  • Anticipated need for additional planned coronary revascularization procedure(s)
  • Hemodynamic instability
  • Mechanical complications of the index acute myocardial infarction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anthony Ting, PhD 216-431-9900 tting@athersys.com
Contact: Cheryl Graveen, BS 216-269-4880 cgraveen@athersys.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02277613
Other Study ID Numbers  ICMJE B02-02
1R44HL117572-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Athersys, Inc
Study Sponsor  ICMJE Athersys, Inc
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Marc Penn, MD Summa Health System
PRS Account Athersys, Inc
Verification Date February 2018

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