UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028324 |
|---|---|
| Receipt number | R000032417 |
| Scientific Title | Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection |
| Date of disclosure of the study information | 2017/07/21 |
| Last modified on | 2024/10/15 16:36:34 |
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Basic information
Public title
Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Acronym
Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Scientific Title
Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Scientific Title:Acronym
Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Region
| Japan |
Condition
Condition
bullous keratopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy and the safety of human cultured corneal endothelial cell transplantation with 3 different volume of cells
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Corneal Endothelial Cell Density > 1000 cells/mm^2 (12W)
Key secondary outcomes
Corneal Endothelial Cell Density > 1000 cells/mm^2 (52W)
Corneal Thickness < 630 micro meter and no corneal epithelial edema(12, 52W)
Improvement of visual acuity (12, 52W)
Improvement of VFQ-25 (12, 52W)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Low volume of cells
Interventions/Control_2
Middle volume of cells
Interventions/Control_3
High volume of cells
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
BSCVA under 0.5
corneal endothelial cell density unmeasurable or under 500cells per mm^2
Corneal thickness over 630 micro meter with corneal epithelial edema
Key exclusion criteria
corneal infection
pregnant
uncontrolable glaucoma
uncontrolable diabetes
drug hypersensitivity
autoimmune disease
under another trial
cancer patient
heart disease
difficult-to-prone maintain
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Kinoshita |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Frontier Medical Science and Technology for Ophthalmology
Zip code
6028566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5772
chcec@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Prefectural University of Medicine
Division name
Department for Medical Innovation and Translational Medical Science
Zip code
6028566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5308
Homepage URL
http://www.ophth.kpu-m.ac.jp/research/kakumaku/cyunyu/
chcec@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Department of Frontier Medical Science and Technology for Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KPUM IRB
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
Tel
075-251-5873
chikenjm@koto.kpu-m.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
京都府立医科大学附属病院（京都府） / University Hospital Kyoto Prefectural University of Medicine
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10384-024-01123-w
Number of participants that the trial has enrolled
15
Results
The primary endpoint was achieving a CEC density of 1000 cells/mm2 or more at 24 weeks post-cHCEC transplant in 4 cases (80%) of high dose group. The secondary endpoint for corneal thickness and best corrected visual acuity was achieving in all cases.
Results date posted
| 2024 | Year | 10 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cell transplantations were conducted to 5 patients of each 3 group (low, medium, high). Mean age was 74.3+-11.9, male/female ratio was 8/7, the number of transplanted eyes was 6 for right, and 9 for left. Disease subtypes were 5 FECD, 5 PBK and PEX-BK, 4 PBK and LI-BK and 1 PBK.
Participant flow
The transplantations underwent at University Hospital Kyoto Prefectural University of Medicine for 13 cases, Kyoto University Hospital for 1 case, National Center for Geriatrics and Gerontology for 1 case.
Adverse events
Adverse events detected more than 2 cases were observed before 24 weeks postinjection as follows: 5 cases of eye pain, 2 cases of eyelid edema, 2 cases of lacrimation increased and 2 cases of intraocular pressure increased. Serious adverse events were observed in 2 cases. 1 case developed gastric cancer and papillary thyroid cancer before 24 weeks postinjection, and the other case suffered femoral neck fracture between 24 weeks and 52 weeks postinjection.
Outcome measures
The primary endpoint was achieving a CEC density of 1000 cells/mm2 or more at 24 weeks post-cHCEC transplant in 4 cases (80%) of high dose group. The secondary endpoint for corneal thickness and best corrected visual acuity was achieving in all cases.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032417
