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Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Age-Related Macular Degeneration (AMD)
Not Recruiting
Trial ID: NCT01632527
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
Stanford Investigator(s)
Theodore Leng, MD, FACS
Associate Professor of Ophthalmology (Ophthalmology Research/Clinical Trials) and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (MSD)
Eligibility
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)
Intervention(s):
drug: HuCNS-SC cells
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lorella Cabael
650-498-4486