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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036539
Receipt No. 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 2019/05/23

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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)
i) 1st series:Patients whose HLA haplotype is unmatched with iPS cell line established from HLA homozygous donor of Japanese most frequent haplotype provided by CiRA
ii) 2nd series:According to the number of uncontrollable rejection up to the second case in the intermediate evaluation:
a. In the event of 0 cases of rejection; patients with unmatched HLA haplotype
b. In the event of 1 cases of rejection; patients with unmatched HLA haplotype
c. In the event of 2 cases of rejection; patients with matched HLA haplotype

3) 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
3) Medical history of allergy to animal (cattle, pigs, or rodent animal)
4) Test positive for Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency Virus, or Adult T-cell Leukemia Virus
5) Malignant tumor within 5 years before registration, or doubtful malignant tumor
6) Glaucoma with uncontrollable IOP
7) Diabetes with uncontrollable glycemic control
8) Pregnant/lactating women, might be pregnant women; wish to become pregnant women
9) Another study participant within 16 weeks before iCEPS transplantation, planning to participate in another trial during this trial
10) Unsuitable for entry in this trial judged by principal investigator or sub-investigators
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 06-6879-3456
Email 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 06-6879-3456
Homepage URL
Email ips_cornea@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Osaka University Graduate School of Medicine
Institute
Department

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
Tel 06-6210-8293
Email 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 Open public recruiting
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 09 Month 30 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
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041628

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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