Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
- Conditions
- Stargardt's Macular DystrophyMacular Degeneration
- Interventions
- Procedure: Subretinal transplantation
- Registration Number
- NCT02749734
- Lead Sponsor
- Southwest Hospital, China
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- Aging from 18 to 75 years
- must have signed informed consent
- At least one visually impaired eye caused by macular degeneration diseases
- Can not be effectively treated with conventional therapies
- Best corrected visual acuity scores between 19 and 73 letter in ETDRs (early treatment diabetic retinopathy ) eye chart , including 19 and 73 (or the equivalent of Snellen eyesight from 20/400 to 20/40)
- Visual loss caused by macular degeneration diseases
- Eyes with concomitant diseases which will interfere the visual improvement of the study
- Active intraocular inflammation regardless of the grade of severity
- Active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, ophthalmia)
- History of uveitis
- Severe cataract, glaucoma, retinal blood vessels occlusion, retinal detachment, macular hole, vitreous-macula traction
- Iris neovascularization
- Patients who have only one functioning eye, or the best corrected vision of untreated eye scores less than 24 letters in ETDRS chart(corresponding to 20/320 in Snellen chart)
- History of intraocular surgery
- Severe systemic diseases: Stroke, coronary heart disease, angina pectoris, renal insufficiency needing dialysis
- Allergic to sodium fluorescein
- Uncontrolled hypertension (systolic pressure>140mmHg,or diastolic pressure>90mmHg)
- Coagulative function disorder
- System administration of drugs that are toxic to lens, retina, or optic nerve like hydroxychloroquine, phenothiazine, ethambutol, tamoxifen, etc.
- Involved in other clinical trials of any medicine within 1 month (or within 5 half-life periods)
- Have maternity plan in 6 months
- In pregnancy or lactation period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description hESC-RPE Subretinal transplantation Subretinal transplantation of Human embryo stem cell derived retinal pigment epitheliums
- Primary Outcome Measures
Name Time Method Number of participants with Treatment-Related Adverse Events [Safety and Tolerability] up to 12 months Patients with Treatment-Related Adverse Events caused by local rejection of implanted cells or systemic immunosuppression treatment
- Secondary Outcome Measures
Name Time Method Flash Electroretinogram (FERG) up to 12 months Retinal electrophysiological function is tested by FERG
Visual Field as examined by Static perimetry up to 12 months Area and sensitivity of visual field are detected by Static perimetry
Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize up to 12 months Visual acuity is reflected by number of ETDR letters participants can recognize
Amplitude and Latency of Flash Visual Evoked Potentials (FVEP) up to 12 months Optic nerve function as assessed by FVEP
Multifocal Electroretinogram (MFERG) up to 12 months Local retinal function as assessed by MFERG
Trial Locations
- Locations (1)
Southwest Hospital
🇨🇳Chongqing, Chongqing, China