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

July 21, 2021 updated by: Athersys, Inc

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Huntsville, Alabama, United States
    • California
      • Los Angeles, California, United States
    • Florida
      • Clearwater, Florida, United States
      • Gainesville, Florida, United States
      • Tampa, Florida, United States, 33614
    • Michigan
      • Detroit, Michigan, United States
    • Ohio
      • Akron, Ohio, United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: AMI MultiStem cells
AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.
Sham Comparator: Sham
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
Other: Sham
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days
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
Day 120

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 365
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
Day 365
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
Day 365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Athersys, Inc

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Marc Penn, MD, SUMMA Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

October 24, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 29, 2014

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B02-02
  • 1R44HL117572-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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