Education and Training
Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Age-Related Macular Degeneration (AMD)
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.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: HuCNS-SC cells
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)
Ages Eligible for Study
50 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lorella Cabael
650-498-4486
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