Safety and Tolerability of MA09-hRPE Cells in Patients With Stargardt's Macular Dystrophy(SMD) (NCT01625559) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability of MA09-hRPE Cells in Patients With Stargardt's Macular Dystrophy(SMD)
South Korea3 participantsStarted 2012-09
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of RPE cellular therapy in patients with SMD
Who can participate
Age range20 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:
* 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