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Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
Not Recruiting
Trial ID: NCT02467634
Purpose
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with
bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.
Official Title
A Phase II Proof-of-Concept Study of the Safety and Efficacy of 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 and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)
Eligibility
Inclusion Criteria:
- GA associated with AMD in both eyes. Total area of GA determined by fundus
autofluorescence.
- BCVA of 20/320 or better in each eye at screening assessment
Exclusion Criteria:
- Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or
fluorescein angiography as determined by the investigator or the reading center.
- Retinal or macular disease of any other cause in either eye.
- Diagnosis of glaucoma in either eye.
- Uncontrolled intraocular pressure in either eye
- Compromised renal function defined as eGFR <60mL/min and urine protein-to-creatinine
ration >0.3 is spot urine collection.
- History of or active autoimmune disease.
- Previous organ, tissue or bone marrow transplantation.
- Seropositive for HIV, hepatitis B or C, or CMV IgM
Intervention(s):
biological: HuCNS-SC sub-retinal transplantation
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305