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Recruitment status Completed
Unique ID issued by UMIN UMIN000011929
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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/
Email hirami@fbri.org

Sponsor
Institute RIKEN
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013279


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