Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
- Conditions
- Age-Related Macular Degeneration
- Registration Number
- NCT02467634
- Lead Sponsor
- StemCells, Inc.
- Brief Summary
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.
- Detailed Description
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method GA area based on fundus autofluorescence 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Retina Associates Southwest, PC
🇺🇸Tucson, Arizona, United States
Retina Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Retinal Diagnostic Center
🇺🇸Campbell, California, United States
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
Rush University Med Ctr.
🇺🇸Chicago, Illinois, United States
William Beaumont Health System
🇺🇸Royal Oak, Michigan, United States
New York Eye and Ear Infirmary
🇺🇸New York, New York, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Retina Foundation of the Southwest
🇺🇸Dallas, Texas, United States
Scroll for more (1 remaining)Retina Associates Southwest, PC🇺🇸Tucson, Arizona, United States