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

Primary Purpose

Age-Related Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HuCNS-SC sub-retinal transplantation
Sponsored by
StemCells, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina Associates Southwest, PC
  • Retina Vitreous Associates Medical Group
  • Retinal Diagnostic Center
  • Northern California Retina Vitreous Associates
  • Retina Research Institute of Texas
  • Rush University Med Ctr.
  • William Beaumont Health System
  • New York Eye and Ear Infirmary
  • Retina Research Institute of Texas
  • Retina Research Center
  • Retina Foundation of the Southwest
  • University Of Utah / John A. Moran Eye Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HuCNS-SC

Arm Description

HuCNS-SC sub-retinal transplantation

Outcomes

Primary Outcome Measures

GA area based on fundus autofluorescence

Secondary Outcome Measures

Full Information

First Posted
June 4, 2015
Last Updated
May 31, 2016
Sponsor
StemCells, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02467634
Brief Title
Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
Acronym
RADIANT
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Based on a business decision unrelated to any safety concerns.
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
StemCells, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HuCNS-SC
Arm Type
Experimental
Arm Description
HuCNS-SC sub-retinal transplantation
Intervention Type
Biological
Intervention Name(s)
HuCNS-SC sub-retinal transplantation
Intervention Description
HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD
Primary Outcome Measure Information:
Title
GA area based on fundus autofluorescence
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Naor, MD
Organizational Affiliation
StemCells, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Retina Associates Southwest, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Retina Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retinal Diagnostic Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retina Research Institute of Texas
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Rush University Med Ctr.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
William Beaumont Health System
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Foundation of the Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University Of Utah / John A. Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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