Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Age-Related Macular Degeneration (AMD)


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Trial ID: NCT01632527


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
Theodore Leng, MD, FACS

Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)


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

   - 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)


drug: HuCNS-SC cells


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lorella Cabael