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The purpose of this study was to determine the safety and therapeutic effect of sub-retinal transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in patients with macular degeneration diseases, and explore new treatment modalities for macular degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hESC-RPE | Experimental | Subretinal transplantation of Human embryo stem cell derived retinal pigment epitheliums |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subretinal transplantation | Procedure | Transplant hESC-RPE into subretinal space of patients with macular degeneration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-Related Adverse Events [Safety and Tolerability] | Patients with Treatment-Related Adverse Events caused by local rejection of implanted cells or systemic immunosuppression treatment | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize | Visual acuity is reflected by number of ETDR letters participants can recognize | up to 12 months |
| Visual Field as examined by Static perimetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital | Chongqing | Chongqing Municipality | 400038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40020685 | Derived | Lv YX, Li QY, Duan P, Zhang MF, Liu B, Li SY, Zhao TT, Wang H, Liu Y, Yin ZQ. Safe CNV removal is crucial for successful hESC-RPE transplantation in wet age-related macular degeneration. Stem Cell Reports. 2025 Mar 11;20(3):102424. doi: 10.1016/j.stemcr.2025.102424. Epub 2025 Feb 27. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 18, 2024 | |
| Unrelease | Sep 22, 2024 | |
| Release | Sep 22, 2024 |
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Area and sensitivity of visual field are detected by Static perimetry
| up to 12 months |
| Flash Electroretinogram (FERG) | Retinal electrophysiological function is tested by FERG | up to 12 months |
| Amplitude and Latency of Flash Visual Evoked Potentials (FVEP) | Optic nerve function as assessed by FVEP | up to 12 months |
| Multifocal Electroretinogram (MFERG) | Local retinal function as assessed by MFERG | up to 12 months |
| Unrelease | Sep 29, 2024 |
| Release | Sep 29, 2024 |
| Reset | Nov 21, 2024 |
| Release | Jan 5, 2025 |
| Reset | Jan 31, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 18, 2024 | Sep 22, 2024 | |||
| Sep 22, 2024 | Sep 29, 2024 | |||
| Sep 29, 2024 | Nov 21, 2024 | |||
| Jan 5, 2025 | Jan 31, 2025 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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