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

Terminated

• Conditions: Geographic Atrophy; Age-Related Macular Degeneration

• Registration Number: NCT02137915
• Lead Sponsor: StemCells, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency and types of serious adverse events	At each of 11 visits over a period of 48 months

Secondary Outcome Measures

Name	Time	Method
Frequency and types of adverse events	At each of 11 visits over a period of 48 months

Trial Locations

Locations (1)

Retina Foundation of the Southwest; 🇺🇸 Dallas, Texas, United States