NCT07192211

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
36mo left

Started Sep 2025

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Sep 2025Mar 2029

First Submitted

Initial submission to the registry

August 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

August 28, 2025

Last Update Submit

September 23, 2025

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Time to the first occurrence of the cardiovascular events

    2 years

Secondary Outcomes (9)

  • Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography

    2years

  • Late Gadolinium Enhancement (LGE) in Cardiac MRI scan

    2 years

  • Left Ventricular Remodeling in Cardiac MRI scan & Echocardiography

    2 years

  • 6-minute walk distance

    2 years

  • New York Heart Association

    2 years

  • +4 more secondary outcomes

Study Arms (2)

Mesenchymal stem cell

EXPERIMENTAL
Biological: Mesenchymal stem cell

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

Mesenchymal stem cellBIOLOGICAL

ADR-002K administration

Mesenchymal stem cell
PlaceboBIOLOGICAL

Placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Shigeru Miyagawa, profesor

    Osaka University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumito Okawa, Study Director

CONTACT

81-3-6832-6014R-regenerative_medicine@rohto.co.jp

Toshiyuki Osawa

CONTACT

81-6-6447-8610R-regenerative_medicine@rohto.co.jp

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 25, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

March 31, 2029

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share