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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02749734
• Other study ID #: 2013CB967002
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: January 7, 2016
• Last updated: January 29, 2018
• Start date: May 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Stargardt's Macular Dystrophy

Intervention

Procedure:
• Subretinal transplantation
Transplant hESC-RPE into subretinal space of patients with macular degeneration

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]	Patients with Treatment-Related Adverse Events caused by local rejection of implanted cells or systemic immunosuppression treatment	up to 12 months
Secondary	Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize	Visual acuity is reflected by number of ETDR letters participants can recognize	up to 12 months
Secondary	Visual Field as examined by Static perimetry	Area and sensitivity of visual field are detected by Static perimetry	up to 12 months
Secondary	Flash Electroretinogram (FERG)	Retinal electrophysiological function is tested by FERG	up to 12 months
Secondary	Amplitude and Latency of Flash Visual Evoked Potentials (FVEP)	Optic nerve function as assessed by FVEP	up to 12 months
Secondary	Multifocal Electroretinogram (MFERG)	Local retinal function as assessed by MFERG	up to 12 months