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

• Sponsor: StemCells, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02137915
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Duration (Months): 25
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration; Geographic Atrophy	Biological: Human Central Nervous System Stem Cells

Study Design

• Study Type: Observational
• Actual Enrollment: 8 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Outcome Measures

Primary Outcome Measures

1. Frequency and types of serious adverse events [At each of 11 visits over a period of 48 months]

Secondary Outcome Measures

1. Frequency and types of adverse events [At each of 11 visits over a period of 48 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 51 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Foundation of the Southwest	Dallas	Texas	United States	75231

Sponsors and Collaborators

• StemCells, Inc.

Investigators

• Principal Investigator: David Birch, Ph.D., Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: StemCells, Inc.
• ClinicalTrials.gov Identifier: NCT02137915
• Other Study ID Numbers: CL-N02-AMD
• First Posted: May 14, 2014
• Last Update Posted: Jun 2, 2016
• Last Verified: May 1, 2016

• Keywords provided by StemCells, Inc.: AMD
• Additional relevant MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy

Study Results

No Results Posted as of Jun 2, 2016