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| Name | Class |
|---|---|
| Beijing Tongren Hospital | OTHER |
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Early Phase I Study of the Safety and Preliminary Efficacy of Human primary Retinal Pigment Epithelial (HuRPE) Cells Subretinal Transplantation in Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA) Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose group | Experimental | 300,000 HuRPE cells |
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| middle dose group | Experimental | 500,000 HuRPE cells |
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| high dose group | Experimental | 1,000,000 HuRPE cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human primary Retinal Pigment Epithelial (HuRPE) cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| best-corrected visual acuity (BCVA) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingxue Zhang, Dr | Contact | 86-18610772626 | jingxuezh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ningli Wang | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D057130 | Leber Congenital Amaurosis |
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D058499 | Retinal Dystrophies |
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| ID | Term |
|---|---|
| D002452 | Cell Count |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D012162 |
| Retinal Degeneration |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |