Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD

A Phase II Proof-of-Concept Study of the Safety and Efficacy of HUCNS-SC Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration

A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.

A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study.

Inclusion Criteria:

• GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence.
• BCVA of 20/320 or better in each eye at screening assessment

Exclusion Criteria:

• Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center.
• Retinal or macular disease of any other cause in either eye.
• Diagnosis of glaucoma in either eye.
• Uncontrolled intraocular pressure in either eye
• Compromised renal function defined as eGFR <60mL/min and urine protein-to-creatinine ration >0.3 is spot urine collection.
• History of or active autoimmune disease.
• Previous organ, tissue or bone marrow transplantation.
• Seropositive for HIV, hepatitis B or C, or CMV IgM