A Phase 2 interventional study of AMI MultiStem cells and Sham in Heart Attack and NSTEMI, sponsored by Healios K.K.. Terminated at 11 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by Healios K.K. · Phase 2, Interventional, and Treatment
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).
Exclusion Criteria:
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 procedure using Micro-Infusion Catheter in coronary artery without injection.
Other: Sham
AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
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
Time frame: 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
Time frame: Day 120
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
Time frame: Day 365
To assess the incidence of Major Adverse Cardiovascular Events (MACE)
To compare the incidence of MACE between AMI MultiStem therapy treated subjects and Sham treated subjects
Time frame: Day 365
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
Time frame: Day 365
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Healios K.K.