Subretinal Transplantation of Retinal Pigment Epitheliums in Treatment of Age-related Macular Degeneration Diseases
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|ClinicalTrials.gov Identifier: NCT02755428|
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dry Age-related Macular Degeneration||Biological: retinal pigment epithelium transplantation||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Safety and Efficacy of Subretinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Age-related Macular Degeneration Diseases|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: retinal pigment epithelium transplantation
Subretinal transplantation of human embryonic stem cell derived retinal pigment epitheliums.
Biological: retinal pigment epithelium transplantation
Transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
- safety and tolerance of transplantation [ Time Frame: one year ]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.
- Efficacy:Early treatment of diabetic retinopathy eye chart (ETDRs) [ Time Frame: one year ]Visual function measure: change in visual acuity
- Efficacy：Best corrected visual acuity（BCVA） [ Time Frame: one year ]Visual function measure: change in visual acuity
- Efficacy：Optical coherent tomography (OCT) [ Time Frame: one year ]Transplant and host retina integrity and survival
- Efficacy：fundus autofluorescence [ Time Frame: one year ]Transplant and host retina integrity and survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755428
|Contact: Wang Liu, Doctorfirstname.lastname@example.org|
|Contact: Hao Jie, Doctoremail@example.com|
|Beijing Tongren Hospitol,Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Wei Wen bin, Doctor +86-01058265736 firstname.lastname@example.org|
|Contact: Yan Yan ni, Doctor +86-01058269804 email@example.com|
|Principal Investigator:||Zhou Qi, Doctor||Institute of zoology, Chinese Academy of Sciences|