Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
30 participants
INTERVENTIONAL
2018-08-01
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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low dose group
300,000 HuRPE cells
Human primary Retinal Pigment Epithelial (HuRPE) cells
HuRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be administered into the subretinal space of experimental eye through a standard surgical approach.
middle dose group
500,000 HuRPE cells
Human primary Retinal Pigment Epithelial (HuRPE) cells
HuRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be administered into the subretinal space of experimental eye through a standard surgical approach.
high dose group
1,000,000 HuRPE cells
Human primary Retinal Pigment Epithelial (HuRPE) cells
HuRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be administered into the subretinal space of experimental eye through a standard surgical approach.
Interventions
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Human primary Retinal Pigment Epithelial (HuRPE) cells
HuRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be administered into the subretinal space of experimental eye through a standard surgical approach.
Eligibility Criteria
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Inclusion Criteria
2. Experimental eye with best-corrected visual acuity (BCVA) of no more than 35 letters or visual field of less than 10 degree;
3. Patient understand and sign the consent form.
Exclusion Criteria
2. Blood biochemistry is abnormal (ALT／AST\>1.5; creatinine\>1.3mg/dL)
3. Experimental eye has optic nerve atrophy caused by glaucoma
4. Experimental eye has retinal detachment, or has received retinal detachment surgery.
5. Patients with uveitis and other endophthalmitis
6. Patients with other ocular disease affecting vision.
7. Patients have participated in clinical study of ocular or systemic drug use in recent 6 months.
8. Patients with medical history of malignant cancer (except resected basal cell carcinoma and squamous-cell carcinoma).
9. Patients with medical history of myocardial infarction
10. Patient with diabetes
11. Patient with Parkinson disease or Alzheimer's disease
12. Patients are under the treatment of immunosuppressive agent (except intermittent, low-dose corticosteroid treatment).
13. Patients with other medical conditions that restricts the compliance and safety of patients, or affects experimental results.
18 Years
70 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Eyecure Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ningli Wang
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital
Locations
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Beijing Tongren Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TR-RPE-RP/LCA
Identifier Type: -
Identifier Source: org_study_id
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