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

StemCells, Inc

Status and phase

Terminated

Phase 2

Conditions

Age-Related Macular Degeneration

Treatments

Biological: HuCNS-SC sub-retinal transplantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT02467634

CL-AMD-201

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No 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