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

Primary Purpose

Heart Attack, NSTEMI

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AMI MultiStem cells
Sham
Sponsored by
Athersys, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Attack focused on measuring stem cells

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

AMI MultiStem cells

Sham

Arm Description

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.

Sham procedure using Micro-Infusion Catheter in coronary artery without injection.

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events
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
To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects

Secondary Outcome Measures

To assess the effects of AMI MultiStem therapy on cardiac function
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)
To compare the incidence of MACE between AMI MultiStem therapy treated subjects and Sham treated subjects
Incidence and severity of adverse events
To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects

Full Information

First Posted
October 24, 2014
Last Updated
July 21, 2021
Sponsor
Athersys, Inc
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02277613
Brief Title
A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
Acronym
MI-NSTEMI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Study Start Date
December 2015 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Athersys, Inc
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Attack, NSTEMI
Keywords
stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMI MultiStem cells
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
Intervention Type
Biological
Intervention Name(s)
AMI MultiStem cells
Intervention Description
AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events
Description
To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects
Time Frame
30 days
Title
To assess the effects of AMI MultiStem therapy on cardiac function
Description
To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects
Time Frame
Day 120
Secondary Outcome Measure Information:
Title
To assess the effects of AMI MultiStem therapy on cardiac function
Description
To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects
Time Frame
Day 365
Title
To assess the incidence of Major Adverse Cardiovascular Events (MACE)
Description
To compare the incidence of MACE between AMI MultiStem therapy treated subjects and Sham treated subjects
Time Frame
Day 365
Title
Incidence and severity of adverse events
Description
To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects
Time Frame
Day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Penn, MD
Organizational Affiliation
Summa Health System
Official's Role
Principal Investigator
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Huntsville
State/Province
Alabama
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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