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

Stopped early

Conditions studied: Age-Related Macular Degeneration, Geographic Atrophy

In brief

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.

Key facts

Study ID

NCT02137915

Run by

StemCells, Inc.

People needed

8

Starts

2014-04-01

Expected to finish

2016-05-01

Last updated by the study team

2016-06-02

Who can join

Age: 51 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Retina Foundation of the Southwest — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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