Study Stopped
Based on a business decision unrelated to any safety concerns.
Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
RADIANT
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
1 other identifier
interventional
3
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2015
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 4, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 2, 2016
May 1, 2016
11 months
June 4, 2015
May 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
GA area based on fundus autofluorescence
12 months
Study Arms (1)
HuCNS-SC
EXPERIMENTALHuCNS-SC sub-retinal transplantation
Interventions
HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- StemCells, Inc.lead
Study Sites (12)
Retina Associates Southwest, PC
Tucson, Arizona, 85724, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Retinal Diagnostic Center
Campbell, California, 95008, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
Retina Research Institute of Texas
Palo Alto, California, 94303, United States
Rush University Med Ctr.
Chicago, Illinois, 60612, United States
William Beaumont Health System
Royal Oak, Michigan, 48073, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Retina Research Center
Austin, Texas, 78705, United States
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
University Of Utah / John A. Moran Eye Center
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Joel Naor, MD
StemCells, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2015
First Posted
June 10, 2015
Study Start
June 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 2, 2016
Record last verified: 2016-05