Long-Term Follow-up Safety Study of Human Central Nervous System Stem Cells in Subjects With Geographic Atrophy of Age-Related Macular Degeneration

StemCells, Inc.8 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Interventions

Human Central Nervous System Stem CellsBIOLOGICAL

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Frequency and types of serious adverse events

Time frame: At each of 11 visits over a period of 48 months

Secondary Outcomes

Frequency and types of adverse events