Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Age-Related Macular Degeneration (AMD)
Trial ID or NCT#
The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of unilateral subretinal transplantation of HuCNS-SC cells in subjects with geographic atrophy secondary to age-related macular degeneration.
Phase I/II Study of the Safety and Preliminary Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
- - Diagnosis of age-related macular degeneration with geographic atrophy (GA) - Only patients with a specific degree and extent of GA will be eligible - Subjects with best-corrected visual acuity (BCVA) of less than or equal to 20/400 in the Study Eye will be enrolled in Cohort I. Subjects with BCVA of 20/320 to 20/100 in the Study Eye will be enrolled in Cohort II - No prior or current choroidal neovascularization in either eye - Must have adequate care-giver support and access to medical care in the local community - Able to provide written informed consent prior to any study related procedures - Agree to comply in good faith with all conditions of the study and to attend all required study visits
- - Prior vitreal or retinal surgery - Glaucoma - Atrophic macular disease of any other cause - Diabetic retinopathy or diabetic macular edema in either eye - Previous organ, tissue or bone marrow transplantation - Previous participation in a gene transfer or a cell transplant trial - Autoimmune disease - Allergy to tacrolimus, mycophenolate mofetil (MMF), scopolamine, Cyclogyl, Moxifloxacin, or Gatifloxacin - Current or prior malignancy (or is on chemotherapy)
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