ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
NCT ID: NCT04695522
Last Updated: 2021-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
6 participants
INTERVENTIONAL
2019-11-27
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group of subjects undergoing cell transplantation
ADR-002K administration
ADR-002K administration
Group of subjects undergoing sham operation
ADR-002K administration
ADR-002K administration
Interventions
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ADR-002K administration
ADR-002K administration
Eligibility Criteria
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Inclusion Criteria
2. Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent
3. Others
Exclusion Criteria
2. Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator
3. Others
20 Years
80 Years
ALL
No
Sponsors
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Rohto Pharmaceutical Co., Ltd.
INDUSTRY
Osaka University
OTHER
Responsible Party
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Daisuke Mori
Assistant professor
Principal Investigators
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Daisuke Mori, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Osaka University Hospital
Locations
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Osaka University Hospital
Suita, Osaka, Japan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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CVSR0006
Identifier Type: -
Identifier Source: org_study_id
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