Clincosm LogoSign in Get a demo

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

Sponsor
StemCells, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02467634
Collaborator
(none)
3
Enrollment
12
Locations
1
Arm
11
Duration (Months)
0.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
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 :
Jun 1, 2015
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. GA area based on fundus autofluorescence [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • StemCells, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
StemCells, Inc.
ClinicalTrials.gov Identifier:
NCT02467634
Other Study ID Numbers:
  • CL-AMD-201
First Posted:
Jun 10, 2015
Last Update Posted:
Jun 2, 2016
Last Verified:
May 1, 2016
Additional relevant MeSH terms:
Macular Degeneration

Study Results

No Results Posted as of Jun 2, 2016