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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-jRCT2053190081 |
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Date of registration:
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11/12/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for ischemic cardiomyopathy
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Scientific title:
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Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for ischemic cardiomyopathy |
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Date of first enrolment:
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10/01/2020 |
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Target sample size:
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10 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCT2053190081 |
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Study type:
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Interventional |
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Study design:
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single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
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Phase:
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1
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Contacts
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Name:
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Shigeru
Miyagawa |
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Address:
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2-15, Yamadaoka, Suita, Osaka
565-0871
Osaka
Japan |
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Telephone:
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+81-6-6879-3154 |
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Email:
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saisentan@tissue.med.osaka-u.ac.jp |
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Affiliation:
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Osaka university hospital |
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Name:
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Takuji
Kawamura |
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Address:
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2-15, Yamadaoka, Suita, Osaka
565-0871
Osaka
Japan |
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Telephone:
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+81-6-6879-3154 |
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Email:
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saisentan@tissue.med.osaka-u.ac.jp |
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Affiliation:
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Osaka university hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) Ischemic cardiomyopathy
2) NYHA class III, IV
3) Patients who can not expect symptomatic improvement with standard treatment for target disease. To be recognized by the third party committee with experts.
4) Ejection fraction <= 35%
Exclusion criteria: 1) Autoimmune disease
2) Allergic or hypersensitive to the immunosuppressant
3) Severe infection
4) Persistent shock due to worsening heart failure
5) Irreversible organ failure other than heart
6) Maignancy
7) Pregnancy
8) Alcoholic or drug addiction in recent six months
9) Allergies or hypersensitivity to animals from which raw materials used
10) Severe pulmonary hypertension
Age minimum:
>= 20age old
Age maximum:
Not applicable
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ischemic cardiomyopathy
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D017202
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Intervention(s)
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D017690
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Human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation
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Primary Outcome(s)
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Number of patients with improved LVEF compared with preoperative at 26 weeks after transplantation
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Secondary Outcome(s)
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1) Number of responders at 26 and 52 weeks after transplantation
2) Evaluation of the following changes before 26 and 52 weeks after transplantation
(1) LVEF
(2) Left ventricular remodeling
(3) Severity of heart failure
(4) Rejections
(5) Others
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Source(s) of Monetary Support
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Cuorips Inc.
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Ethics review
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Status: Approval
Approval date: 28/09/2019
Contact:
jim-chiken@hp-crc.med.osaka-u.ac.jp
Instisutional review board of Osaka university hospital
+81-6-6210-8290
jim-chiken@hp-crc.med.osaka-u.ac.jp
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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