Age-Related Macular Degeneration, Geographic Atrophy
Conditions
Keywords
AMD
Brief summary
This study is being done to determine the long-term safety and possible benefits of transplanted Human Central Nervous System Stem Cells (HuCNS-SC) for patients with Geographic Atrophy of Age-Related Macular Degeneration. This long-term follow-up study is limited to those individuals who received a transplant of HuCNS-SC cells into one of their eyes as part of the CL-N01-AMD study. No additional study product will be given in this 4-year long-term follow-up study.
Interventions
BIOLOGICALHuman Central Nervous System Stem Cells
Sponsors
StemCells, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
51 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have completed Study CL-N01-AMD * Must be 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
* Inability to comply with study procedures or visits * Since enrolling in Study CL-N01-AMD, have entered, or are about to enter another investigational study that, in the opinion of the Principal Investigator (PI), might confound study interpretation. * Received off-study immunosuppressive agents in the lead-in study or are receiving any immunosuppressive agents since completing the lead-in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and types of serious adverse events | At each of 11 visits over a period of 48 months |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and types of adverse events | At each of 11 visits over a period of 48 months |
Countries
United States
Outcome results
None listed