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

NCT02277613 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-07-22

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Healios K.K.

    lead INDUSTRY

Principal Investigators

  • Marc Penn, MD · Summa Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2019-06-30
Completion
2020-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02277613 on ClinicalTrials.gov