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 |
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
Transplantation of autologous iPSC derived RPE cell sheet in subject with exudative AMD
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
Transplantation of autologous iPSC derived RPE cell sheet in subject with exudative AMD
Japan |
Exudative age related macular degeneration
Ophthalmology |
Others
NO
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
Safety
Exploratory
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
Interventional
Parallel
Non-randomized
Open -no one is blinded
Uncontrolled
2
Treatment
Device,equipment | Maneuver | Other |
The size of the RPE sheet used in the first 3 cases will be 1.3 mm x 3 mm
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.
50 | years-old | <= |
Not applicable |
Male and Female
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
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
6
1st name | |
Middle name | |
Last name | Masayo Takahashi |
RIKEN
Laboratory for Retinal Regeneration
2-2-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo
078-306-3305
retinalab@cdb.riken.jp
1st name | |
Middle name | |
Last name | Yasuhiko Hirami |
Kobe City Medical Center General Hospital
Department of Ophthalmology
2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo
078-302-4321
http://www.riken-ibri.jp/AMD/
hirami@fbri.org
RIKEN
AMED
MHLW
Japanese Governmental office
Japan
Foundation for Biomedical Research and Innovation
Kobe City Medical Center general Hospital
NO
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)
2013 | Year | 10 | Month | 02 | Day |
Partially published
https://www.nejm.org/doi/full/10.1056/NEJMoa1608368
1
Completed
2013 | Year | 07 | Month | 29 | Day |
2013 | Year | 07 | Month | 29 | Day |
2013 | Year | 10 | Month | 02 | Day |
2019 | Year | 02 | Month | 28 | Day |
The trial was halted after two patients because of Japan's Regenerative Medicine Law of 2014
2013 | Year | 10 | Month | 01 | Day |
2019 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013279