Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases

Army Medical University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Stargardt's Macular Dystrophy

Macular Degeneration

Treatments

Procedure: Subretinal transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02749734

2013CB967002

Details and patient eligibility

About

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).

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.