Ischemic Heart DiseasePhase 2NCT07192211
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG
A Phase 2 study testing Mesenchymal stem cell in people with Ischemic Heart Disease, run by Rohto Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Mesenchymal stem cell
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- 28 Apr 2026to 31 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients clinically diagnosed with chronic heart failure due to ischemic heart disease who undergo CABG
- Patients with an LVEF of less than 40% as determined by the cardiac ultrasound at the screening examination.
- Others
Who cannot join
- Patients who have a combination of cardiovascular disease such as severe organic valvular disease.
- Patients who have developed acute coronary syndrome within 3 months prior to obtaining consent.
- Others
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
The University of Osaka Hospital
Osaka, Suita, 5650871
081-6-6879-5111, jim-chiken@hp-crc.med.osaka-u.ac.jp
About this study
Official title: Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo Coronary Artery Bypass Surgery
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.
Read the detailed description
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.
- Conditions
- Ischemic Heart Disease
- Being tested
- Mesenchymal stem cell, Placebo
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellBiological
ADR-002K administration
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell | Experimental | Not described Receives: Biological: Mesenchymal stem cell |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first occurrence of the cardiovascular events
Measured: 2 years
Secondary outcomes (9)
Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography
Changes of LVEF in 2years after ADR-002K administration
Measured: 2years
Late Gadolinium Enhancement (LGE) in Cardiac MRI scan
Changes of LGE in the 2years after ADR-002K administration
Measured: 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
Measured: 2 years
6-minute walk distance
Changes of 6-minute walk distance in 2 years after ADR-002K administration
Measured: 2 years
New York Heart Association Symptoms
Changes of New York Heart Association in 2 years after ADR-002K administration
Measured: 2 years
The Kansas City Cardiomyopathy Questionnaire（KCCQ)
Changes of KCCQ scores in 2 years after ADR-002K administration
Measured: 2 years
Minesota Living With Heart Failure Questinanaire（MLHFQ）
Changes of MLHFQ scores in 2 years after ADR-002K administration
Measured: 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
Measured: 2 years
Adverse Events
Number and rate of adverse events related to this product
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start28 Apr 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rohto Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeru Miyagawa, profesor, Principal investigator, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192211
- Sponsor's protocol ID
- ADR-002K-0223
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT07192211
- Acronym / sponsor ID
- ADR-002K-0223
- Conditions
- Ischemic Heart Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rohto Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell | Experimental | Biological: Mesenchymal stem cell |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients clinically diagnosed with chronic heart failure due to ischemic heart disease who undergo CABG
- Patients with an LVEF of less than 40% as determined by the cardiac ultrasound at the screening examination.
- Others
Key exclusion criteria (3 listed)
- Patients who have a combination of cardiovascular disease such as severe organic valvular disease.
- Patients who have developed acute coronary syndrome within 3 months prior to obtaining consent.
- Others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stem cellADR-002K administration | Biological | Mesenchymal stem cell |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Time to the first occurrence of the cardiovascular events
Time frame: 2 years
9 secondary outcomes
Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography
Time frame: 2years
Late Gadolinium Enhancement (LGE) in Cardiac MRI scan
Time frame: 2 years
Left Ventricular Remodeling in Cardiac MRI scan & Echocardiography
Time frame: 2 years
6-minute walk distance
Time frame: 2 years
New York Heart Association Symptoms
Time frame: 2 years
The Kansas City Cardiomyopathy Questionnaire（KCCQ)
Time frame: 2 years
Minesota Living With Heart Failure Questinanaire（MLHFQ）
Time frame: 2 years
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Time frame: 2 years
Adverse Events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shigeru Miyagawa, profesor principal investigator
Osaka University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal stem cell in people with Ischemic Heart Disease, run by Rohto Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sumito Okawa, Study Director (81-3-6832-6014, R-regenerative_medicine@rohto.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the first occurrence of the cardiovascular events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.