Clinical trial NCT02467634: Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Lead sponsor: StemCells, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-10
Enrollment: 3
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: GA area based on fundus autofluorescence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Retina Associates Southwest, PC
state: Arizona
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Palo Alto
country: United States
facility: Retina Research Institute of Texas
state: California
city: Chicago
country: United States
facility: Rush University Med Ctr.
state: Illinois
city: Royal Oak
country: United States
facility: William Beaumont Health System
state: Michigan
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Salt Lake City
country: United States
facility: University Of Utah / John A. Moran Eye Center
state: Utah
Study officials:
affiliation: StemCells, Inc.
name: Joel Naor, MD
role: STUDY_CHAIR
References: