UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026003
Receipt No. 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 2017/10/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Yasuo Kurimoto
Organization Kobe City Medical Center General Hosital
Division name Department of Ophthalmology
Zip code
Address 2-1-1, Manatojima-minamimachi, Chuo-ku, Kobe Japan
TEL 078-302-4321
Email ykurimoto@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Utako Shirono
Organization Kobe City Medical Center General Hosital
Division name Clinical Trial Management Center
Zip code
Address 2-1-1, Manatojima-minamimachi, Chuo-ku, Kobe Japan
TEL 078-302-5489
Homepage URL http://chuo.kcho.jp/index.php
Email ts-cr@kcho.jp

Sponsor
Institute Department of Ophthalmology, Kobe City Medical Center General Hosital
Institute
Department

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
Email

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 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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 06 Day
Last follow-up date
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
2017 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029894

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.