ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
Phase I Trial of ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
1 other identifier
interventional
6
1 country
1
Brief Summary
Ischemic cardiomyopathy undergoing coronary artery bypass surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2019
1 active site
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 Start
First participant enrolled
November 27, 2019
CompletedFirst Submitted
Initial submission to the registry
December 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedJanuary 5, 2021
January 1, 2021
1.4 years
December 9, 2020
January 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants with Adverse event
Safety assessment related to adverse events and this product
26 weeks
Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery
Efficacy (Exploratory)
26 weeks
Number of complication associated with drug administration method
Feasibility of drug administration method
26 weeks
Study Arms (2)
Group of subjects undergoing cell transplantation
EXPERIMENTALGroup of subjects undergoing sham operation
SHAM COMPARATORInterventions
ADR-002K administration
Eligibility Criteria
You may qualify if:
- Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG
- Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent
- Others
You may not qualify if:
- Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure
- Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator
- Others
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Osaka Universitylead
- Rohto Pharmaceutical Co., Ltd.collaborator
Study Sites (1)
Osaka University Hospital
Suita, Osaka, 5650871, Japan
Related Publications (1)
Kawamura T, Yoshioka D, Kawamura A, Misumi Y, Taguchi T, Mori D, Saito S, Yamauchi T, Hata H, Miyagawa S. Safety and therapeutic potential of allogeneic adipose-derived stem cell spray transplantation in ischemic cardiomyopathy: a phase I clinical trial. J Transl Med. 2024 Dec 2;22(1):1091. doi: 10.1186/s12967-024-05816-1.
PMID: 39623426DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Daisuke Mori, Ph.D
Osaka University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
December 9, 2020
First Posted
January 5, 2021
Study Start
November 27, 2019
Primary Completion
April 30, 2021
Study Completion
October 31, 2021
Last Updated
January 5, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share