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

Status: Terminated

Conditions: Age-Related Macular Degeneration; Geographic Atrophy

Treatments: Biological: Human Central Nervous System Stem Cells

Study type: Observational

Funder types: Industry

Identifiers

NCT02137915

CL-N02-AMD

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 51+ years old

Volunteers: No Healthy Volunteers

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