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

UMIN ID: UMIN000011929

Registered date:02/10/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Exudative age related macular degeneration
• Date of first enrollment: 2013/10/02
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: 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 inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: RIKEN
• Secondary Sponsor: Foundation for Biomedical Research and Innovation Kobe City Medical Center general Hospital
• Source(s) of Monetary Support: AMED MHLW