Status:
TERMINATED
A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
Lead Sponsor:
Healios K.K.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Attack
NSTEMI
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT02277613
Start Date
December 1 2015
End Date
January 1 2020
Last Update
July 22 2021
Active Locations (11)
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1
Birmingham, Alabama, United States
2
Huntsville, Alabama, United States
3
Los Angeles, California, United States
4
Clearwater, Florida, United States