Retinitis pigmentosa
Conditions
Interventions
subretinal transplantation of allogenic iPSC-retinal sheets (up to 3 pieces)
Sponsors
Hirami Yasuhiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) clinically diagnosed as retinitis pigmentosa based on the diagnostic criteria of the designated intractable disease 2) 20 years of age or older 3) Severity grade IV by severity classification guideline under the diagnostic criteria of the designated intractable disease (corrected visual acuity less than 0.2) 4) MD values less than -30dB by Humphrey visual field test 5) Capable of understanding the documents of the research context and of informed consent and is able to provide a written informed consent
Exclusion criteria
Exclusion criteria: 1) Ocular infection 2) Glaucoma with poorly controlled intraocular pressure 3) The affected eye was received intraocular surgeries other than cataract surgery within 3 months 4) Any of bilirubin level, albumin level, and prothrombin time is outside the normal range as a criterion for liver function. 5) Either creatinine level or eGFR (estimated glomerular filtration rate) is outside the normal range as a standard for renal function. 6) B hepatitis virus, C hepatitis virus, human immunodeficiency virus, adult T-cell leukemia virus, cases of syphilis-positive 7) Unable to quit anti-coagulants or anti-platelet medication 8) Malignant carcinoma or its history in the past 3 years 9) Family history of hereditary tumors 10) Allergic to fluorescein or indocyanine green angiography 11) Possible pregnancy or breastfeeding, or with the partner having a wish for pregnancy 12) Enrolled in another clinical study in the past 1 month 13) Judged inadequate by the principal investigator and coresearchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Increase in retinal thickness after subretinal transplantation of allogenic iPSC-retinal sheets 2) Safety of allogenic iPSC-retinal sheets iPSC-retinal sheets (safety of cell processing product and presence or absence of immune rejection or unexpected graft proliferation) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety of therapeutic procedure of subretinal transplantation of allogenic iPSC-retinal sheets 2) Efficacy of therapeutic procedure of subretinal transplantation of allogenic iPSC-retinal sheets (visual function and quality of life assessment) | — |
Countries
Japan
Contacts
Public ContactShigeki Yamasaki
Kobe City Eye Hospital
Outcome results
None listed