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

Phase 2

Terminated

• Conditions: Heart Attack; NSTEMI
• Interventions: Biological: AMI MultiStem cells; Other: Sham

• Registration Number: NCT02277613
• Lead Sponsor: Healios K.K.

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 available

Study Timeline

• Study First Submitted: 2014-10-24
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-29
• Study Start: 2015-12
• Primary Completion: 2019-06
• Study Completion: 2020-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMI MultiStem cells	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.
Sham	Sham	Sham procedure using Micro-Infusion Catheter in coronary artery without injection.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	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	Day 120	To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects

Secondary Outcome Measures

Name	Time	Method
To assess the incidence of Major Adverse Cardiovascular Events (MACE)	Day 365	To compare the incidence of MACE between AMI MultiStem therapy treated subjects and Sham treated subjects
Incidence and severity of adverse events	Day 365	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	Day 365	To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects