Exploratory Study of ADR-002K for Heart Failure Patients... | NCT07192211

Studies
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG

NCT07192211

Sponsor

Rohto Pharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Jun 9, 2026Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

Ischemic Heart Disease

Interventions

Mesenchymal stem cell
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 28, 2026Actual

Primary Completion Date

Sep 30, 2028Estimated

Completion Date

Mar 31, 2029Estimated

First Submitted Date

Aug 28, 2025

First Submission Date that Met QC Criteria

Sep 23, 2025

First Posted Date

Sep 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2026

Last Update Posted Date

Jun 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mesenchymal stem cell	Experimental		Biological: Mesenchymal stem cell
Placebo	Placebo Comparator		Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mesenchymal stem cell	Biological	ADR-002K administration	Mesenchymal stem cell

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to the first occurrence of the cardiovascular events		2 years

Secondary Outcomes

Measure	Description	Time Frame
Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography	Changes of LVEF in 2years after ADR-002K administration	2years
Late Gadolinium Enhancement (LGE) in Cardiac MRI scan

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sumito Okawa, Study Director	Contact	81-3-6832-6014		R-regenerative_medicine@rohto.co.jp
Toshiyuki Osawa	Contact	81-6-6447-8610		R-regenerative_medicine@rohto.co.jp

Overall Officials

Name	Affiliation	Role
Shigeru Miyagawa, profesor	Osaka University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Osaka Hospital	Recruiting	Osaka	Suita	5650871	Japan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided