臨床研究等提出・公開システム

allogeneic iPS cell-derived retinal pigmented epithelium (RPE) cell suspension for RPE impaired disease (aiPSC-RPE CS transplantation forRID)

Clinical Research of allogeneic iPSC-RPE cell suspension transplantation for RPE impaired disease (CR of aiPSC-RPE CS transplantation forRID)

Kurimoto Yasuo

Kurimoto Yasuo

Kobe City Eye Hospital

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

e_jrct@kcho.jp

Yamazaki 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 RPE impaired disease on the diagnostic criteria
2) male or female at 20 years of age or older
3) Window defect is observed by FAG.
4) collected visual acuity is less than 0.3 or less, or visual field measured with Goldman dynamic quantitative visual field (target: V-4) is within 20 degrees, or Estherman static quantitative visual field is 70 points or less.
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 antiplatelet medication
8) Malignant carcinoma or its history in the past 3 years, however, this does not exclude patients with a history of carcinoma in situ.
9) Family history of hereditary tumors
10) Patients with contraindications for contrast agents, such as fluorescein or indocyanine green, antibacterial agents, steroids, immunosuppressants or anesthetics used in this clinical study
11) May be pregnant during lactation or lactation. The patient or partner is planning a pregnancy.
12) Participating in clinical studies involving other clinical trials or interventions within 1 month before obtaining consent or at the present time.
13) Judged inadequate by the principal investigator and coresearchers
14) When the case review meeting determines that it is "unsuitable".

Both

RPE impaired disease

subretinal transplantation of human allogenic iPSC-RPE cell suspension (up to 50 micro L involving 250 thousand cells

Reduction of window defect area (RPE abnormal lesion) by engraftment of transplanted allogeneic iPS cell-derived RPE cells

1) Effectiveness of allogeneic iPS cell-derived RPE cell transplantation (visual function/QOL)
2) Search for indicators of visual function evaluation for allogeneic iPS cell-derived RPE cell transplantation
3) Safety of transplantation of allogeneic iPS cell-derived RPE cells

Not Recruiting

+81-6-6210-8293

Nov. 12, 2020

Yes

To share clinical data obtained from cases attended to the clinical research with NRMD that has been anonymized clinical research plan after the end of the clinical research.

none