Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
Not provided
Not provided
Not provided
Not provided
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 of patients to treat dry age-related macular degeneration(dry-AMD). Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the safety and efficacy of RPE transplants to treat dry AMD.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| retinal pigment epithelium transplantation | Experimental | transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD). |
|
| 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 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:Early treatment of diabetic retinopathy eye chart (ETDRs) | Visual function measure: change in visual acuity | 12 months |
| Efficacy:Best corrected visual acuity(BCVA) | Visual function measure: change in visual acuity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Zhengzhou university | Recruiting | Zhengzhou | Henan | 450052 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open Label
Not provided
| 12 months |
| Efficacy:Optical coherent tomography (OCT) | Visual function measure | 12 months |
| Efficacy:fundus autofluorescence | Transplant and host retina integrity and survival | 12 months |
| Efficacy:vision inspection | Changes of judgment after transplantation of patient's visual field | 12 months |