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| ID | Type | Description | Link |
|---|---|---|---|
| U01EY030581 | U.S. NIH Grant/Contract | View source | |
| UG3EY031810 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Eye Institute (NEI) | NIH |
| Regenerative Research Foundation | UNKNOWN |
| California Institute for Regenerative Medicine (CIRM) |
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The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
RPESC-RPE-4W is Allogeneic RPE stem cell (RPESC)-derived RPE cells (RPESC-RPE) isolated from the RPE layer of human cadaveric eyes are transplanted under the macular.
This first-in-human Phase 1/2a open-label dose-escalation interventional study plans to enroll a total of 18 subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50,000 cells | Experimental | Six patients will receive single dose of 50,000 RPESC-RPE-4W cells in the eye. |
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| 150,000 cells | Experimental | Six patients will receive single dose of 150,000 RPESC-RPE-4W cells in the eye. |
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| 250,000 cells | Experimental | Six patients will receive single dose of 250,000 RPESC-RPE-4W cells in the eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPESC-RPE-4W | Biological | RPESC-RPE-4W |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of RPESC-RPE-4W transplantation | The transplantation of RPESC-RPE-4W cells will be considered safe and tolerated in the absence of:
| 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the mean of Best Corrected Visual Acuity (BCVA) | Change in visual acuity will be measured by ETDRS chart. | 24 months |
| Loss of ≥10 decibels of ten-degree average visual sensitivity microperimetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey H Stern, M.D., Ph.D. | Contact | 05184371111 | jeffreystern@luxabiotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Rajesh C Rao, M.D. | University of Michigan Kellogg Eye Center | Principal Investigator |
| Theodore Leng, MD, FACS | Spencer Center for Vision Research at Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Vitreous Associates Medical Group | Recruiting | Beverly Hills | California | 90211 | United States |
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| OTHER |
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Loss of ≥10 decibels of ten-degree average visual sensitivity will by measured by microperimetry.
| 24 months |
| Change in GA lesion area | Change in GA lesion area will be measured. | 24 months |
| Evidence of structural changes | Structural evidence will be measured by OCT imaging, autofluorescence, fluorescein angiography, and fundus photography | 24 months |
| David S Liao, MD, PhD | Retina-Vitreous Associates Medical Group | Principal Investigator |
| Spencer Center for Vision Research | Recruiting | Palo Alto | California | 94303 | United States |
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| University of Michigan Kellogg Eye Center | Recruiting | Ann Arbor | Michigan | 48105 | United States |
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