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Keep this study
Lead
StemCells, Inc.
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.
Age
50–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
