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

Age-Related Macular Degeneration Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02467634
• Other study ID #: CL-AMD-201
• Status: Terminated
• Phase: Phase 2
• First received: June 4, 2015
• Last updated: May 31, 2016
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: StemCells, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Biological:
• HuCNS-SC sub-retinal transplantation
HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Retina Research Center	Austin	Texas
United States	Retina Vitreous Associates Medical Group	Beverly Hills	California
United States	Retinal Diagnostic Center	Campbell	California
United States	Rush University Med Ctr.	Chicago	Illinois
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	New York Eye and Ear Infirmary	New York	New York
United States	Retina Research Institute of Texas	Palo Alto	California
United States	William Beaumont Health System	Royal Oak	Michigan
United States	University Of Utah / John A. Moran Eye Center	Salt Lake City	Utah
United States	Retina Associates Southwest, PC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
StemCells, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GA area based on fundus autofluorescence		12 months	No