Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02467634
Recruitment Status : Terminated (Based on a business decision unrelated to any safety concerns.)
First Posted : June 10, 2015
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
StemCells, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Biological: HuCNS-SC sub-retinal transplantation Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. GA area based on fundus autofluorescence [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467634


Locations
Layout table for location information
United States, Arizona
Retina Associates Southwest, PC
Tucson, Arizona, United States, 85724
United States, California
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Retinal Diagnostic Center
Campbell, California, United States, 95008
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
Retina Research Institute of Texas
Palo Alto, California, United States, 94303
United States, Illinois
Rush University Med Ctr.
Chicago, Illinois, United States, 60612
United States, Michigan
William Beaumont Health System
Royal Oak, Michigan, United States, 48073
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, Texas
Retina Research Institute of Texas
Abilene, Texas, United States, 79606
Retina Research Center
Austin, Texas, United States, 78705
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
United States, Utah
University Of Utah / John A. Moran Eye Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
StemCells, Inc.
Investigators
Layout table for investigator information
Study Chair: Joel Naor, MD StemCells, Inc.
Layout table for additonal information
Responsible Party: StemCells, Inc.
ClinicalTrials.gov Identifier: NCT02467634    
Other Study ID Numbers: CL-AMD-201
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases