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
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
- Heart Attack
- NSTEMI
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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