UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026003 |
|---|---|
| Receipt number | R000029894 |
| Scientific Title | A Study of transplantation of allogenic induced pluripotent stem cell (iPSC) derived retinal pigment epithelium (RPE) cell suspension in subjects with neovascular age related macular degeneration |
| Date of disclosure of the study information | 2017/02/06 |
| Last modified on | 2021/01/03 21:41:53 |
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Basic information
Public title
A Study of transplantation of allogenic induced pluripotent stem cell (iPSC) derived retinal pigment epithelium (RPE) cell suspension in subjects with neovascular age related macular degeneration
Acronym
Transplantation of allogenic iPSC derived RPE cell suspension in subject with neovascular AMD
Scientific Title
A Study of transplantation of allogenic induced pluripotent stem cell (iPSC) derived retinal pigment epithelium (RPE) cell suspension in subjects with neovascular age related macular degeneration
Scientific Title:Acronym
Transplantation of allogenic iPSC derived RPE cell suspension in subject with neovascular AMD
Region
| Japan |
Condition
Condition
Neovascular age related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objectives of this clinical study are to evaluate the safety as well as the feasibility and visual function efficacy of transplantation of RPE cells differentiated from allogenic iPS cells induced from the peripheral blood of 6 HLA locus homozygous donor for HLA haplotype matched subjects with neovascular AMD.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The safety of the investigational treatment: the presence or absence, severity and frequency of each of the following adverse events (AE) due to the iPS cell-derived RPE cell transplantation surgery.
[Adverse events associated with the iPSC-derived RPE cells]
1. Graft failure, immune rejection
2. Excessive proliferation or tumorigenesis by the graft cells
[Adverse events associated with the transplantation surgery or its procedure]
1. Retinal, choroidal or vitreous hemorrhage
2. Retinal detachment
Key secondary outcomes
(1) Safety
The severity and frequency of AEs other than those described above and are associated with iPSC derived RPE cells.
The severity and frequency of AEs other than those described above and are associated with the transplantation surgery or its procedure.
The severity, frequency, and type of all AEs (based on the CTCAE v4.0-JCOG) other than those described above.
(2) Efficacy
- Foveal retinal thickness, subretinal fluid, retinal edema by OCT.
- Retinal sensitivity accessed by multi-local ERG and microperimetry .
- Visual acuity.
- The dye leakage of CNV by fluorescence angiography
- The interval period until next treatment of anti-VEGF drugs because of the recurrence of CNV and the anti-VEGF drug treatment times during 1 year from the RPE cell transplantation.
- Change in QOL.
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
Subretinal transplantation of allogenic iPSC derived RPE cells
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) At least one eye has been diagnosed with wet AMD (including PCV and RAP)
2) Men and women 50 years of age and more, 85 years of age and less
3) Presence of subfoveal lesions of any of CNV, fibrotic scar, RPE atrophy or RPE tear without surgically removable lesions
4) Corrected visual acuity not less than hand motion and less than 0.3
5) The eye has relapse or incomplete resolution of exudative changes after receiving at least one additional anti-VEGF agent following 3 injections of induction therapy (total of at least 4 injections) or anti-VEGF agent is considered ineffective for exudative changes.
6) With or without dye leakage by fluorescein angiography
7) Well understood and written informed consent has been obtained from the patient.
8) Matched with HLA haplotype A*24:02-C*12:02-B*52:01-DRB1*15:02-DQB1*06:01-DPB1*09:01
Key exclusion criteria
(1)-4) applicable only in subject eye)
1) Ocular infection
2) Other retinal disease (diabetic retinopathy, hypertensive retinopathy, vascular occlusion, etc.)
3) Optic nerve atrophy
4) Glaucoma with poorly controled intraocular pressure
5) Severe liver dysfunction (AST/ALT 100 IU/L or higher)
6) Severe renal impairment that require dialysis
7) Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency Virus, Adult T-cell Leukemia Virus, cases of Syphilis-positive
8) Allergic to bovine serum or antibiotics (penicillin, streptomycin)
9) Unable to quit anti-coagulants or anti-platelet medication
10) Malignant carcinoma (except for carcinoma in situ) or its history in the past 3 years
11) Allergic to fluorescein or indocyanine green angiography
12) Possible pregnancy or with the partner having a wish for pregnancy
13) Enrolled in another clinical study in the past 1 month
14) Judged unsuitable for study participation by the principal investigator or co-investigators
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Kurimoto |
Organization
Kobe City Eye Hospital
Division name
Department of Ophthalmology
Zip code
650-0047
Address
2-1-8, Manatojima-minamimachi, Chuo-ku, Kobe Japan
TEL
078-381-9876
ykurimoto@mac.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Shibatani |
Organization
Kobe City Eye Hospital
Division name
Research Center
Zip code
650-0047
Address
2-1-8, Manatojima-minamimachi, Chuo-ku, Kobe Japan
TEL
078-381-9876
Homepage URL
e_kenkyujimu@kcho.jp
Sponsor or person
Institute
Kobe City Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
1.Osaka University Hospital
2.Center for iPS Cell Research and Application
3.RIKEN
Name of secondary funder(s)
IRB Contact (For public release)
Organization
-
Address
-
Tel
-
-
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
神戸市立医療センター中央市民病院（兵庫県）
国立大学法人大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/9/7/2217
Number of participants that the trial has enrolled
5
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
| 2017 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 20 | 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 | 02 | Month | 04 | Day |
Last modified on
| 2021 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029894
