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| Name | Class |
|---|---|
| Beijing Tongren Hospital | OTHER |
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This project intends to transplant a clinical level human embryonic stem cells derived retinal pigment epithelium into subretinal space to treat eetinitis pigmentosa(RP) diseases. Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the efficacy and safety 0f RPE transplants to treat RP disease.
This project intends to transplant a clinical level human embryonic stem cells derived retinal pigment epithelium into subretinal space to treat eetinitis pigmentosa(RP) diseases. Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the efficacy and safety 0f RPE transplants to treat RP disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| retinal pigment epitheliums transplantation | Experimental | Transplant clinical-grade hESC derived retinal pigment epitheliums into subretinal of patients with retinitis pigmentosa.The dosage is 150000. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retinal pigment epitheliums transplantation | Biological | Subretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and serious adverse events occurred within 1 year after transplantation | The occurrence of adverse events (AE), severe adverse events (SAE), treatment-related adverse events (TEAE), and clinically significant vital signs during the study period. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of visual function | The changes of BCVA and EDTRS were observed one year after surgery. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhou Qi, Doctor | Institute of Zoology, Chinese Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospitol,Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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