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Based on a business decision unrelated to any safety concerns.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HuCNS-SC | Experimental | HuCNS-SC sub-retinal transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HuCNS-SC sub-retinal transplantation | Biological | HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD |
|
| Measure | Description | Time Frame |
|---|---|---|
| GA area based on fundus autofluorescence | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Naor, MD | StemCells, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Associates Southwest, PC | Tucson | Arizona | 85724 | United States | ||
| Retina Vitreous Associates Medical Group |
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| Beverly Hills |
| California |
| 90211 |
| United States |
| Retinal Diagnostic Center | Campbell | California | 95008 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| Retina Research Institute of Texas | Palo Alto | California | 94303 | United States |
| Rush University Med Ctr. | Chicago | Illinois | 60612 | United States |
| William Beaumont Health System | Royal Oak | Michigan | 48073 | United States |
| New York Eye and Ear Infirmary | New York | New York | 10003 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
| University Of Utah / John A. Moran Eye Center | Salt Lake City | Utah | 84132 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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