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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-UMIN000036539 |
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Date of registration:
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23/05/2019 |
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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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First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency
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Scientific title:
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First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency - First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency |
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Date of first enrolment:
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2019/05/23 |
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Target sample size:
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4 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041628 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase I
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kohji
Nishida |
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Address:
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2-2, Yamada-oka, Suita, Osaka
Japan |
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Telephone:
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06-6879-3451 |
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Email:
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ips_cornea@ophthal.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicine Department of Ophthalmology |
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Name:
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Takeshi
Soma |
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Address:
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2-2, Yamada-oka, Suita, Osaka
565-0871
Japan |
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Telephone:
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06-6879-3451 |
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Email:
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ips_cornea@ophthal.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicine Department of Ophthalmology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Contraindication to antimicrobials, steroid drugs, and anesthetics used in the trial 2) Allergy to antibiotics of penicillin, streptomycin, or animal (cattle, pigs, or rodent animal) 3) Test positive for Hepatitis B virus, Hepatitis C virus or Human Immunodeficiency Virus
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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limbal stem-cell deficiency
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Intervention(s)
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Transplantation of iPS derived corneal epithelial cell sheet (iCEPS)
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Primary Outcome(s)
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Safety: Adverse events
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Secondary Outcome(s)
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Efficacy: 1) LSCD staging 2) corneal epithelial defect 3) subjective symptom 4) visual acuity 5) QOL 6) corneal opacity 7) corneal neovascularization 8) symblepharon
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Source(s) of Monetary Support
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Japan Agency for Medical Research and Development (AMED)
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Ethics review
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Status: YES
Approval date: 10/01/2019
Contact:
nintei@dmi.med.osaka-u.ac.jp
The First Certified Special Committee for Regenerative Medicine, Osaka University
06-6210-8293
nintei@dmi.med.osaka-u.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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13/12/2021 |
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URL:
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