JPRN-jRCTa050200122
Active, not recruiting
Phase 1
allogeneic iPS cell-derived retinal pigmented epithelium (RPE) cell suspension for RPE impaired disease - aiPSC-RPE CS transplantation forRID
Kurimoto Yasuo0 sites50 target enrollmentStarted: January 28, 2021Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Kurimoto Yasuo
- Enrollment
- 50
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •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
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 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
Investigators
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