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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02277613

Acronym

MI-NSTEMI

Enrollment

Registered

2014-10-29

Start date

2015-12-31

Completion date

2020-01-31

Last updated

2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Attack, NSTEMI

Keywords

stem cells

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).

Interventions

BIOLOGICALAMI MultiStem cells

AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.

OTHERSham

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026