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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2016

Interventions

  • Biological: Human Central Nervous System Stem Cells

Clinical Trial Outcome Measures

Primary Measures

  • Frequency and types of serious adverse events
    • Time Frame: At each of 11 visits over a period of 48 months

Secondary Measures

  • Frequency and types of adverse events
    • Time Frame: At each of 11 visits over a period of 48 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 51 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • StemCells, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Birch, Ph.D., Principal Investigator, Principal Investigator

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