Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Age-Related Macular Degeneration (AMD)
Trial ID or NCT#
NCT01632527
Status
NOT RECRUITING
Purpose
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.
Official Title
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
Eligibility Criteria
Ages Eligible for Study: Older than 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- * 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
Exclusion Criteria:
- * 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)
Investigator(s)
Theodore Leng, MD, FACS
Ophthalmologist
Professor of Ophthalmology (Ophthalmology Research/Clinical Trials) and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (MSD)
Contact us to find out if this trial is right for you.
Contact
Lorella Cabael
650-498-4486
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