UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011929 |
|---|---|
| Receipt number | R000013279 |
| Scientific Title | A Study of transplantation of autologous induced pluripotent stem cell (iPSC) derived retinal pigment epithelium (RPE) cell sheet in subjects with exudative age related macular degeneration |
| Date of disclosure of the study information | 2013/10/02 |
| Last modified on | 2019/04/05 11:12:03 |
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Basic information
Public title
A Study of transplantation of autologous induced pluripotent stem cell (iPSC) derived retinal pigment epithelium (RPE) cell sheet in subjects with exudative age related macular degeneration
Acronym
Transplantation of autologous iPSC derived RPE cell sheet in subject with exudative AMD
Scientific Title
A Study of transplantation of autologous induced pluripotent stem cell (iPSC) derived retinal pigment epithelium (RPE) cell sheet in subjects with exudative age related macular degeneration
Scientific Title:Acronym
Transplantation of autologous iPSC derived RPE cell sheet in subject with exudative AMD
Region
| Japan |
Condition
Condition
Exudative age related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this trial of retinal pigment epithelium (RPE) replacement, the aim will be to evaluate the safety and feasibility/efficacy of treating subjects with exudative age-related macular degeneration (AMD) by transplanting autologous iPSC derived RPE sheets
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of the proposed treatment protocol: incidence and severity of adverse events related to the use of autologous iPSC derived RPE sheet.
<Adverse events related to iPSC derived RPE sheet>
1 Poor survival of the graft, immune rejection
2 Tumor formation
<Adverse events related to surgical procedure>
1. Retinal detachment, choroidal hemorrhage, vitreous hemorrhage
2 Retinal tear and retinal detachment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver | Other |
Interventions/Control_1
The size of the RPE sheet used in the first 3 cases will be 1.3 mm x 3 mm
Interventions/Control_2
In the 3 following cases, the use of RPE sheets of a larger size, or of in multiple number with the same size, will be allowed. In case of using multiple sheets, maximum of 3 sheets will be used.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis of exudative AMD including non-typical subtypes in at least one eye.
2) Male and female subjects aged 50 year and older at the time of acquired consent
3) Presence of subfoveal CNV, fibrotic scar, or RPE tear related to exudative AMD
4) The visual acuity of less than 0.3 but better than hand motion.
5) Treatment history of standard anti-VEGF therapy with limited effects such as poor response or persistent recurrence (minimum treatment with anti-VEGF induction therapy followed by at least one additional injection)
6) The mean Central 4-degree retinal sensitivity of less than 5 db on MicroPerimeter1 (MP-1) examination
7) Able to understand and willing to sign the informed consent
Key exclusion criteria
1) Presence of ocular infection
2) Presence of other retinal diseases such as diabetic retinopathy, hypertensive retinopathy, retinal vessel occlusions.
3) Presence of optic nerve atrophy
4) Presence of glaucoma of uncontrolled ocular pressure
5) Presence of significant hepatic failure (with either AST or ALT higher than 100 IU/L)
6) Presence of renal failure
7) Negative serum tests for human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) or syphilis.
8)No history of allergic reaction to antibiotics or bovine serum
9) No medical requirements for a continuous treatment of anti-coagulants or anti-platelets
10) Medically suitable for general anesthesia
11) No presence of or history of malignancy in past 5 years
12) No history of allergic reaction to ICG or Fluorescein
13) Pregnant females; breastfeeding females; and females of childbearing potential.
14) No participation in other clinical trials that involve the last one month before informed consent is obtained
15) Medically judged inadequate by the docters responsible for this study
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayo Takahashi |
Organization
RIKEN
Division name
Laboratory for Retinal Regeneration
Zip code
Address
2-2-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo
TEL
078-306-3305
retinalab@cdb.riken.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Hirami |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Ophthalmology
Zip code
Address
2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo
TEL
078-302-4321
Homepage URL
http://www.riken-ibri.jp/AMD/
hirami@fbri.org
Sponsor or person
Institute
RIKEN
Institute
Department
Personal name
Funding Source
Organization
AMED
MHLW
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Foundation for Biomedical Research and Innovation
Kobe City Medical Center general Hospital
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
先端医療センター病院（兵庫県）
理化学研究所 多細胞システム形成研究センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.nejm.org/doi/full/10.1056/NEJMoa1608368
Number of participants that the trial has enrolled
1
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
| 2013 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The trial was halted after two patients because of Japan's Regenerative Medicine Law of 2014
Management information
Registered date
| 2013 | Year | 10 | Month | 01 | Day |
Last modified on
| 2019 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013279
