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

Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02137915
• Other study ID #: CL-N02-AMD
• Status: Terminated
• Phase: N/A
• First received: May 12, 2014
• Last updated: May 31, 2016
• Start date: April 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: StemCells, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years and older

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Biological:
• Human Central Nervous System Stem Cells

Locations

Country	Name	City	State
United States	Retina Foundation of the Southwest	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
StemCells, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and types of serious adverse events		At each of 11 visits over a period of 48 months	Yes
Secondary	Frequency and types of adverse events		At each of 11 visits over a period of 48 months	Yes