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.
Full Title of Study: “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”
- Study Type: Interventional
- Study Design
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: May 2016
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.
- Biological: HuCNS-SC sub-retinal transplantation
- HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD
Arms, Groups and Cohorts
- Experimental: HuCNS-SC
- HuCNS-SC sub-retinal transplantation
Clinical Trial Outcome Measures
- GA area based on fundus autofluorescence
- Time Frame: 12 months
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: 90 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- StemCells, Inc.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Joel Naor, MD, Study Chair, StemCells, Inc.
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