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

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Trial ID: NCT02137915

Purpose

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.

Official Title

Long-Term Follow-up Study of the Phase I/II Safety and Preliminary Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration

Stanford Investigator(s)

Theodore Leng, MD, FACS
Theodore Leng, MD, FACS

Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)

Eligibility


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

Intervention(s):

biological: Human Central Nervous System Stem Cells

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Zayna Shaheen
650-497-9205