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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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1 July 2024 |
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Main ID: |
JPRN-jRCT2033210163 |
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Date of registration:
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23/06/2021 |
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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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A phase I/II study of human induced Pluripotent Stem (iPS) cell-derived cardiomyocyte spheroids in patients with severe heart failure, secondary to ischemic heart disease, undergoing coronary artery bypass grafting
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Scientific title:
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A phase I/II study of human induced Pluripotent Stem (iPS) cell-derived cardiomyocyte spheroids in patients with severe heart failure, secondary to ischemic heart disease, undergoing coronary artery bypass grafting - LAPiS Study |
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Date of first enrolment:
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23/06/2021 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCT2033210163 |
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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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1-2
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Contacts
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Name:
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Takehiko
Kaneko |
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Address:
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1-2-3, Shibaura, Minato-ku Tokyo
105-0023
Tokyo
Japan |
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Telephone:
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+81-3-6380-1068 |
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Email:
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chiken@heartseed.jp |
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Affiliation:
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Heartseed Inc. |
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Name:
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Toiawase
madoguchi |
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Address:
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1-2-3, Shibaura, Minato-ku Tokyo
160-0023
Tokyo
Japan |
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Telephone:
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+81-3-6380-1068 |
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Email:
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chiken@heartseed.jp |
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Affiliation:
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Heartseed Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with ischemic heart disease undergoing CABG
Patients with resting left ventricular ejection fraction (from 0.15 to 0.40) based on institutional assessment on either screening cardiac MRI or echocardiographic assessment
New York Heart Association Class II, III or IV
Exclusion criteria: Patients who are candidates for cardiovascular surgery other than CABG (such as valvular heart surgery)
Patients with the following complications
Pulmonary hypertension, hypertension, diabetes, liver dysfunction, liver dysfunction, gait disturbance, active infection, active bleeding
Age minimum:
>= 20age old
Age maximum:
<= 80age old
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Heart failure with ischemic heart disease
Ischemic heart disease, Heart Failure, Coronary artery bypass grafting (CABG)
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Intervention(s)
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During CABG with median sternotomy, human induced Pluripotent Stem (iPS) cell-derived cardiomyocyte spheroids are transplanted to anterior, lateral, posterior and inferior using spheroid transplantation needle.
Dose; 50 million or 150 million cells / body.
After transplantation, subject take Immunosuppressant (taclolims, MMF and steroid).
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Primary Outcome(s)
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Safety
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Secondary Outcome(s)
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Heart function
QOL
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Source(s) of Monetary Support
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Ethics review
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Status: Approval
Approval date: 12/04/2021
Contact:
chiken@tmghig.jp
Tokyo Metropolitan Geriatric Medical Center Institutional Review Board
+81-3-3964-1141
chiken@tmghig.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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