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Safety study using allogenic iPSC-retinal sheets for patients with retinitis pigmentosa (iRERP)

Safety Study of allogenic hiPSC-retinas in Retinitis Pigmentosa (hiRERP)

Kurimoto Yasuo

Hirami Yasuhiko

Kobe City Eye Hospital

2-1-8 Minatojima-minamimachi, Chuo-ku, Kobe Hyogo

e_jrct@kcho.jp

Yamasaki Shigeki

Kobe City Eye Hospital

2-1-8 Minatojima-minamimachi, Chuo-ku, Kobe Hyogo

+81-78-381-9876

e_jrct@kcho.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

Retinitis pigmentosa

subretinal transplantation of allogenic iPSC-retinal sheets (up to 3 pieces)

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)

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)

Not Recruiting

+81-6-6210-8293

Feb. 10, 2020