Study Stopped
Based on a business decision unrelated to any safety concerns.
Long-Term Follow-up Safety Study of Human Central Nervous System Stem Cells in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
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
1 other identifier
observational
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 2, 2016
May 1, 2016
2.1 years
May 12, 2014
May 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency and types of serious adverse events
At each of 11 visits over a period of 48 months
Secondary Outcomes (1)
Frequency and types of adverse events
At each of 11 visits over a period of 48 months
Interventions
Eligibility Criteria
All subjects with age-related macular degeneration (AMD) with GA who received transplantation of HuCNS-SC in Study CL-N01-AMD.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- StemCells, Inc.lead
Study Sites (1)
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Birch, Ph.D.
Principal Investigator
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2014
First Posted
May 14, 2014
Study Start
April 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 2, 2016
Record last verified: 2016-05