NCT02277613

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2015

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

3.5 years

First QC Date

October 24, 2014

Last Update Submit

July 21, 2021

Conditions

Heart AttackNSTEMI

Keywords

stem cells

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • To assess the effects of AMI MultiStem therapy on cardiac function

    Day 365

  • To assess the incidence of Major Adverse Cardiovascular Events (MACE)

    Day 365

  • Incidence and severity of adverse events

    Day 365

Study Arms (2)

AMI MultiStem cells

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Other: Sham

Interventions

AMI MultiStem cellsBIOLOGICAL

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

AMI MultiStem cells
ShamOTHER

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

Sham

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Huntsville, Alabama, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Clearwater, Florida, United States

Location

Unknown Facility

Gainesville, Florida, United States

Location

Unknown Facility

Tampa, Florida, 33614, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Akron, Ohio, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

MeSH Terms

Conditions

Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Marc Penn, MD

    Summa Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2014

First Posted

October 29, 2014

Study Start

December 1, 2015

Primary Completion

June 1, 2019

Study Completion

January 1, 2020

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

US(11)