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

NCT ID: NCT02749734

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-12-31

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).

Conditions

Macular Degeneration; Stargardt's Macular Dystrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hESC-RPE

Subretinal transplantation of Human embryo stem cell derived retinal pigment epitheliums

Group Type: EXPERIMENTAL

Subretinal transplantation

Intervention Type: PROCEDURE

Transplant hESC-RPE into subretinal space of patients with macular degeneration

Interventions

Subretinal transplantation

Transplant hESC-RPE into subretinal space of patients with macular degeneration

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

ZhengQin Yin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Southwest Hospital

Chongqing, Chongqing Municipality, China

Countries

China

References

Lv YX, Li QY, Duan P, Zhang MF, Liu B, Li SY, Zhao TT, Wang H, Liu Y, Yin ZQ. Safe CNV removal is crucial for successful hESC-RPE transplantation in wet age-related macular degeneration. Stem Cell Reports. 2025 Mar 11;20(3):102424. doi: 10.1016/j.stemcr.2025.102424. Epub 2025 Feb 27.

Reference Type: DERIVED

PMID: 40020685 (View on PubMed)

Other Identifiers

2013CB967002

Identifier Type: -

Identifier Source: org_study_id