Study Overview

Details

NCTId: NCT02467634

Status: Terminated

Condition: Age-Related Macular Degeneration

Study Type: Interventional

Sponsor: StemCells, Inc.

Study Description

Brief

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

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.

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 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

Healthy Volunteers: No

Gender: All

Min Age: 50 Years

Max Age: 90 Years

Contacts

University Of Utah / John A. Moran Eye Center

Salt Lake City

Utah

84132

United States