UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036539 |
|---|---|
| Receipt number | R000041628 |
| Scientific Title | First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency |
| Date of disclosure of the study information | 2019/05/23 |
| Last modified on | 2023/05/27 13:31:49 |
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Basic information
Public title
First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency
Acronym
First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency
Scientific Title
First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency
Scientific Title:Acronym
First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency
Region
| Japan |
Condition
Condition
limbal stem-cell deficiency
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this clinical research are to evaluate the safety as well as the feasibility and efficacy of transplantation of iPS derived corneal epithelial cell sheet (iCEPS) for LSCD patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety:
Adverse events
Key secondary outcomes
Efficacy:
1) LSCD staging
2) corneal epithelial defect
3) subjective symptom
4) visual acuity
5) QOL
6) corneal opacity
7) corneal neovascularization
8) symblepharon
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Transplantation of iPS derived corneal epithelial cell sheet (iCEPS)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Limbal stem-cell deficiency patients who have been classified as LSCD Stage IIB, IIC, or III
2)Aged 20 years old and over, and written informed consent has been obtained from the patient.
Key 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
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Kohji |
| Middle name | |
| Last name | Nishida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3451
ips_cornea@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Soma |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3451
Homepage URL
ips_cornea@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The First Certified Special Committee for Regenerative Medicine, Osaka University
Address
4F Center of Medical Innovation and Translational Research, 2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8293
nintei@dmi.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041628
