Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Ep… (NCT02749734) | Clinical Trial Compass
UnknownPhase 1/2
Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
China15 participantsStarted 2015-05
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, phe…
What they're measuring
1
Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]