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| Name | Class |
|---|---|
| Beijing Tongren Hospital | OTHER |
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This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space of patients to treat dry age-related macular degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants to treat dry AMD.
This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space to treat age-related macular degeneration(AMD).
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 of RPE transplants to treat AMD disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| retinal pigment epithelium transplantation | Experimental | Subretinal transplantation of human embryonic stem cell derived retinal pigment epitheliums. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| retinal pigment epithelium transplantation | Biological | Transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD). |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerance of transplantation | The safety and tolerance of transplantation of clinical grade hESC-derived RPE will be considered safe: no above moderate adverse events or severe adverse events which related to transplantation of retinal pigment epithelial cells ; Cells without infectious; No tumorigenicity. Through the clinical signs of subjects and laboratory examination to judge the tolerance, integrity, repellency of RPE cells, and monitoring the presence of local or systemic infection, and presence of metastatic tumor cells. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:Early treatment of diabetic retinopathy eye chart (ETDRs) | Visual function measure: change in visual acuity | one year |
| Efficacy:Best corrected visual acuity(BCVA) | Visual function measure: change in visual acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Liu, Doctor | Contact | +86-01064807858 | wangliu@ioz.ac.cn | |
| Hao Jie, Doctor | Contact | +86-01062558737 | haojie@ioz.ac.cn |
| 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 | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 26, 2023 | |
| Reset | Feb 15, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 26, 2023 | Feb 15, 2024 |
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Open Label
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| one year |
| Efficacy:Optical coherent tomography (OCT) | Transplant and host retina integrity and survival | one year |
| Efficacy:fundus autofluorescence | Transplant and host retina integrity and survival | one year |