May. 10, 2021 |
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Aug. 02, 2024 |
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jRCT2033210078 |
Phase I investigator-initiated study of the safety of MTC001 in patients with chronic ischemic heart failure |
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Phase I study of MTC001 in patients with chronic ischemic heart failure |
Machino Takeshi |
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University of Tsukuba Hospital |
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2-1-1, Amakubo, Tsukuba-shi, Ibaraki, 305-8576, Japan |
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+81-29-853-3143 |
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machino@md.tsukuba.ac.jp |
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Hashimoto Koichi |
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University of Tsukuba |
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2-1-1, Amakubo, Tsukuba-shi, Ibaraki, 305-8576, Japan |
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+81-29-853-3326 |
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koichi.hashimoto@md.tsukuba.ac.jp |
Suspended |
June. 01, 2021 |
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July. 25, 2022 | ||
6 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1)Patients diagnosed with heart failure with old myocardial infarction as the underlying disease. |
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1)Diabetic patients who have difficulty controlling their condition (HbA1c over 8.5%). |
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20age 0month 0week old over | ||
85age 0month 0week old not | ||
Both |
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Patients with chronic ischemic heart failure who are not eligible for left ventricular assist device |
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Myocardial biopsy. |
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Heart Failure, Chronic heart failure |
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catheter |
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D006333 |
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D057785 |
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<Safety evaluation> |
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<Tolerability evaluation> |
Metcela Inc. | |
Applicable |
Japan Agency for Medical Research and Development | |
Not applicable |
University of Tsukuba Hospital Institutional Review Board | |
2-1-1, Amakubo, Tsukuba-shi, Ibaraki | |
+81-29-853-3914 |
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chiken@un.tsukuba.ac.jp | |
Approval | |
Mar. 09, 2021 |
none |