Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD (RADIANT)

May 31, 2016 updated by: StemCells, Inc.

A Phase II Proof-of-Concept Study of the Safety and Efficacy of HUCNS-SC Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration

A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

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
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Retina Associates Southwest, PC
    • California
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associates Medical Group
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates
      • Palo Alto, California, United States, 94303
        • Retina Research Institute of Texas
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Med Ctr.
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Health System
    • New York
      • New York, New York, United States, 10003
        • New York Eye and Ear Infirmary
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Austin, Texas, United States, 78705
        • Retina Research Center
      • Dallas, Texas, United States, 75231
        • Retina Foundation of the Southwest
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University Of Utah / John A. Moran Eye Center

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

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence.
  • BCVA of 20/320 or better in each eye at screening assessment

Exclusion Criteria:

  • Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center.
  • Retinal or macular disease of any other cause in either eye.
  • Diagnosis of glaucoma in either eye.
  • Uncontrolled intraocular pressure in either eye
  • Compromised renal function defined as eGFR <60mL/min and urine protein-to-creatinine ration >0.3 is spot urine collection.
  • History of or active autoimmune disease.
  • Previous organ, tissue or bone marrow transplantation.
  • Seropositive for HIV, hepatitis B or C, or CMV IgM

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HuCNS-SC
HuCNS-SC sub-retinal transplantation
Biological: HuCNS-SC sub-retinal transplantation
HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GA area based on fundus autofluorescence
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

StemCells, Inc.

Investigators

  • Study Chair: Joel Naor, MD, StemCells, Inc.

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

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 10, 2015

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-AMD-201

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 HuCNS-SC sub-retinal transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe