Back to resultsADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
Primary Purpose
D017202
Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ADR-002K administration
Sponsored by
About this trial
This is an interventional treatment trial for D017202 focused on measuring Coronary artery bypass, Ischemic cardiomyopathy, Adipose-derived mesenchymal stem cells, Regenerative medicine, Spray method
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Osaka University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Group of subjects undergoing cell transplantation
Group of subjects undergoing sham operation
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with Adverse event
Safety assessment related to adverse events and this product
Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery
Efficacy (Exploratory)
Number of complication associated with drug administration method
Feasibility of drug administration method
Secondary Outcome Measures
Full Information
NCT ID
NCT04695522
First Posted
December 9, 2020
Last Updated
January 2, 2021
Sponsor
Osaka University
Collaborators
Rohto Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04695522
Brief Title
ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
Official Title
Phase I Trial of ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osaka University
Collaborators
Rohto Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Ischemic cardiomyopathy undergoing coronary artery bypass surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
D017202
Keywords
Coronary artery bypass, Ischemic cardiomyopathy, Adipose-derived mesenchymal stem cells, Regenerative medicine, Spray method
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group of subjects undergoing cell transplantation
Arm Type
Experimental
Arm Title
Group of subjects undergoing sham operation
Arm Type
Sham Comparator
Intervention Type
Biological
Intervention Name(s)
ADR-002K administration
Intervention Description
ADR-002K administration
Primary Outcome Measure Information:
Title
Number of participants with Adverse event
Description
Safety assessment related to adverse events and this product
Time Frame
26 weeks
Title
Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery
Description
Efficacy (Exploratory)
Time Frame
26 weeks
Title
Number of complication associated with drug administration method
Description
Feasibility of drug administration method
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daisuke Mori, Ph.D
Phone
+81-6-6879-3154
Email
daimolion@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Masao Sasai, Ph.D
Phone
+81-6-6879-3154
Email
sasai-masao@tissue.med.osaka-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daisuke Mori, Ph.D
Organizational Affiliation
Osaka University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
5650871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daisuke Mori, Ph.D
Phone
+81-6-6879-3154
Email
daimolion@gmail.com
First Name & Middle Initial & Last Name & Degree
Masao Sasai, Ph.D
Phone
+81-6-6105-5240
Email
sasai-masao@tissue.med.osaka-u.ac.jp
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
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