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

May 31, 2016 updated by: StemCells, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75231
        • Retina Foundation of the Southwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects with age-related macular degeneration (AMD) with GA who received transplantation of HuCNS-SC in Study CL-N01-AMD.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

StemCells, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Estimate)

June 2, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-N02-AMD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age-Related Macular Degeneration

Clinical Trials on Human Central Nervous System Stem Cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe