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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Heart Attack, NSTEMI

In brief

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).

Key facts

Study ID

NCT02277613

Run by

Healios K.K.

People needed

34

Starts

2015-12-01

Expected to finish

2020-01-01

Last updated by the study team

2021-07-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Clearwater, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Detroit, Michigan, United States
• Study site — Akron, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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