Safety and Tolerability of MA09-hRPE Cells in Patients With Stargardt's Macular Dystrophy(SMD)

CHA Biotech

Status and phase

Completed

Phase 1

Conditions

Stargardt's Macular Dystrophy

Treatments

Biological: MA09-hRPE

Study type

Interventional

Funder types

Industry

Identifiers

CHA_CTP_0903

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of RPE cellular therapy in patients with SMD

Full description

to evaluate the safety and tolerability of RPE cellular therapy in patients with SMD
to evaluate the preliminary efficacy of MA09-hPRE in patients with SMD

Enrollment

3 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult male or female over 20 years of age.
Clinical diagnosis of advanced SMD.
The visual acuity of the eye to receive the transplant will be no better than hand movement.
The visual acuity of the eye that is not to receive the transplant will be no better than 24 (20/320) Early Treatment of Diabetic Retinopathy Study (ETDRS) letters.

Exclusion criteria

History of malignancy.
History of myocardial infarction in previous 12 months.
History of diabetes mellitus.
Any immunodeficiency.
Any current immunosuppressive therapy other than intermittent or low dose cortico steroids.
Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
Current participation in any other clinical trial.
Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration.
Any other sight-threatening ocular disease.
Any chronic ocular medications. Any history of retinal vascular disease (compromised blood-retinal barrier). Glaucoma. Uveitis or other intraocular inflammatory disease. Significant lens opacities or other media opacity. Ocular lens removal within previous 3 months