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
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Among 45 studies in Non-ST Elevated Myocardial Infarction with a site in United States — 3 open to participants now, 10 under way, none of them phase 3. Non-ST Elevated Myocardial Infarction · United States.
Among the 45 studies in Non-ST Elevated Myocardial Infarction with a site in United States, this one is the 21st largest by enrollment of the 27 interventional ones that give a count, is one of 3 that started in 2015, is one of 3 in phase 2, and was the 15th registered.
284 studies on the registry are indexed under Non-ST Elevated Myocardial Infarction; 52 are open to participants now.
Browse Non-ST Elevated Myocardial Infarction studies →3 of the 45 studies in Non-ST Elevated Myocardial Infarction with a site in United States are open now. Recruiting first, the newest first:
University of South Florida · Sites in United States
Ages 18+
Baim Institute for Clinical Research · Sites in United States
Ages 18+
SB Technology, Inc. · Sites in United States
Ages 22+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 40 Non-ST Elevated Myocardial Infarction studies recruiting now, 34 (85%) set no upper age limit and 1 (3%) stops at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
45 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 34 is below the median of 244 across 146 interventional studies indexed under Non-ST Elevated Myocardial Infarction.
Median enrollment 500 across the 27 interventional studies, 406 across the 18 observational. Of the 31 that completed or were terminated, 15 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
19 of 45 have an industry lead sponsor. The 10 most frequent:
Healios K.K. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Healios K.K. has 1 study filed under Non-ST Elevated Myocardial Infarction — fewer than ten, so there is no comparison to draw.
4 of the studies in Non-ST Elevated Myocardial Infarction with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05800951Henry Ford Health SystemCan Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock | 2026-12-31 |
| NCT07822581SB Technology, Inc."Discovery2" Study of Using MCG at Emergency Departments | 2027-02-28 |
| NCT05284747AmgenEVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction | 2027-05-29 |
| NCT05946629M.A. Med Alliance S.A.SELUTION 4 De Novo Small Vessel IDE Trial | 2027-09 |
Add all 4 to your calendar (.ics) → With an account.
Among the 45 studies in Non-ST Elevated Myocardial Infarction with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
284 studies on the registry are indexed under Non-ST Elevated Myocardial Infarction; 52 are open to participants now.
This study's enrollment of 34 is below the median of 244 across 146 interventional studies indexed under Non-ST Elevated Myocardial Infarction.
Browse Non-ST Elevated Myocardial Infarction studies →Healios K.K. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Compared within Non-ST Elevated Myocardial Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myocardial Infarction. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Dec 2015 to primary completion in Jun 2019, 42 months.
How these figures are worked out, and which studies are left out of them.
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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Non-ST Elevated Myocardial Infarction →
Healios K.K.