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

Heart Attack Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02277613
• Other study ID #: B02-02
• Secondary ID: 1R44HL117572-01A
• Status: Terminated
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: January 2020

Study information

• Verified date: July 2021
• Source: Athersys, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: January 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Attack
• Infarction
• Myocardial Infarction
• NSTEMI

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Athersys, Inc	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Primary	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	Day 120
Secondary	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	Day 365
Secondary	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	Day 365
Secondary	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	Day 365