A Phase 2 interventional study of Mesenchymal stem cell and Placebo in Ischemic Heart Disease, sponsored by Rohto Pharmaceutical Co., Ltd.. Recruiting at 1 site in Japan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Rohto Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
Among 30 studies in Myocardial Ischemia with a site in Japan — 4 open to participants now, 5 under way, none of them phase 3. Myocardial Ischemia · Japan.
Among the 30 studies in Myocardial Ischemia with a site in Japan, this one is the 17th largest by planned enrollment of the 22 interventional ones that give a count, is one of 2 that started in 2026, is the only one in phase 2, and was the 28th registered.
1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.
Browse Myocardial Ischemia studies →4 of the 30 studies in Myocardial Ischemia with a site in Japan are open now. Recruiting first, the newest first:
Heartseed Inc. · Sites in Japan
Ages 20–80
TCROSS Co., Ltd. · Sites in Japan
Ages 18+
Takeshi Morimoto · Sites in Japan
Ages 20+
A study can be open while its sites in Japan have not opened yet or have stopped. Only those recruiting at a site in Japan →
Of the 135 Myocardial Ischemia studies recruiting now, 92 (68%) set no upper age limit and 6 (4%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.
This study: 18 Years to 80 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.
30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 3 · Phase 3 2 · Phase 4 5
First in 2002; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 116 across 622 interventional studies indexed under Myocardial Ischemia.
Median enrollment 350 across the 22 interventional studies, 577 across the 8 observational. Of the 22 that completed or were terminated, 13 (59%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 30 have an industry lead sponsor. The 10 most frequent:
Rohto Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Rohto Pharmaceutical Co., Ltd. has 1 study filed under Myocardial Ischemia — fewer than ten, so there is no comparison to draw.
2 of the studies in Myocardial Ischemia with a site in Japan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07373353Abbott Medical DevicesA Clinical Evaluation of AMJ-401 | 2027-01-31 |
| NCT06436092TCROSS Co., Ltd.Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry) | 2027-05-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 30 studies in Myocardial Ischemia with a site in Japan, from their registry updates:
This tab as a report to print or save as PDF → With an account.
ADR-002K is administered to heart failure patients with ischemic heart disease who undergo coronary artery bypass surgery (CABG) to investigate its efficacy and safety.
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. ADR-002K (Adipose-derived mesenchymal stem cells) is administered to the surface of the heart in patients with ischemic heart disease who undergo CABG. The efficacy and safety of ADR-002K are evaluated until the last patient has completed the 2-year evaluation.
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.
Biological: Mesenchymal stem cell
Biological: Placebo
ADR-002K administration
Placebo
Time to the first occurrence of the cardiovascular events
Time frame: 2 years
Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography
Changes of LVEF in 2years after ADR-002K administration
Time frame: 2years
Late Gadolinium Enhancement (LGE) in Cardiac MRI scan
Changes of LGE in the 2years after ADR-002K administration
Time frame: 2 years
Left Ventricular Remodeling in Cardiac MRI scan & Echocardiography
Changes of Left Ventricular End-Systolic Volume Index, Left Ventricular End-Diastolic Volume Index, Left Ventricular End-Systolic Diameter, Left Ventricular End-Diastolic Diameter) in 2 years after ADR-002K administration
Time frame: 2 years
6-minute walk distance
Changes of 6-minute walk distance in 2 years after ADR-002K administration
Time frame: 2 years
New York Heart Association Symptoms
Changes of New York Heart Association in 2 years after ADR-002K administration
Time frame: 2 years
The Kansas City Cardiomyopathy Questionnaire（KCCQ)
Changes of KCCQ scores in 2 years after ADR-002K administration
Time frame: 2 years
Minesota Living With Heart Failure Questinanaire（MLHFQ）
Changes of MLHFQ scores in 2 years after ADR-002K administration
Time frame: 2 years
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Changes of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in 2 years after ADR-002K administration
Time frame: 2 years
Adverse Events
Number and rate of adverse events related to this product
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Sep 2028, 29 months after the start.
Of 16 phase 2 interventional studies under Myocardial Ischemia, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's planned 29 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Mesenchymal Stem Cell
Rohto Pharmaceutical Co., Ltd.