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This project intends to perform autologous transplantation of induced pluripotent stem cell-derived retinal pigment epithelium (iPSC-RPE). The clinical-grade RPE will be transplanted into subretinal space to treat refractory age-related macular degeneration. The efficacy and safety of RPE transplants to treat macular degeneration will be monitored and analyzed with results from EDTRS, BCVA, OCT, ERG, microperimetry, and fluorescein angiography, before and after the treatment.
The investigators will generate iPSC lines from recruited participants and differentiate the iPSC into RPE. Autologous iPSC-derived RPE will be transplanted into participants eyes by subretinal injections. The safety and efficacy will be closely monitored and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving intervention | Experimental | Participants will receive autologous transplantation of induced pluripotent stem cell-derived retinal pigment epitheliums. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous iPSC-derived RPE | Biological | Autologous transplantation of iPSC-derived RPE |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety measure | Safety will be assessed by Adverse Events (AEs) of special interest in regards to the investigational product. This will include obtaining information about Serious Adverse Events (SAEs) that are neurologic, infectious, hematologic or fatal, any AE that causes the subject to withdraw from the study, any new diagnosis of an ocular or immune-mediated disorder, cancer (irrespective of prior history), ectopic or proliferative cell growth (RPE or non-RPE) with adverse clinical consequence, unexpected, clinically significant AE possibly related to the cell transplant procedure or the investigational product (autologous iPSC-RPE), pregnancy in a female subject or the partner of a male subject and pregnancy outcome. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) | Change in visual acuity will be measured by Early Treatment Diabetic Retinopathy Study (ETDRS) chart. | 12 months |
| Optical coherence tomography (OCT) imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohui Zhang | Contact | +0086-(010)58265915 | zhangxh711@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospitol,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100730 | China |
Detailed plan will be made based on institute regulations and funder policies. The investigators will adjust the plan case-by-case accordingly.
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D005128 | Eye Diseases |
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The number of patients with serious retinal detachment, retinal hemorrhage, and cystoid macular edema, and the change in target treatment areas.
| 12 months |
| Color and autofluorescence imaging | Change in target treatment areas. | 12 months |
| Fluorescein angiography | Change in target treatment areas. | 12 months |
| Fundus autofluorescence | Change in target treatment areas. | 12 months |
| Microperimetry | Exploratory evaluations for the change of retinal sensitivity from baseline in the region of interest. | 12 months |
| Electroretinography (ERG) | Exploratory evaluations for the change of retinal electrophysiology responses from baseline. | 12 months |