Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)
NCT04627428 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-10-15
Summary
The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
Conditions
Interventions
- BIOLOGICAL
-
RPESC-RPE-4W
RPESC-RPE-4W
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Eye Institute (NEI)
collaborator NIH -
Regenerative Research Foundation
collaborator UNKNOWN -
California Institute for Regenerative Medicine (CIRM)
collaborator OTHER -
Luxa Biotechnology, LLC
lead INDUSTRY
Principal Investigators
-
Rajesh C Rao, M.D. · University of Michigan Kellogg Eye Center
-
Theodore Leng, MD, FACS · Spencer Center for Vision Research at Stanford University
-
David S Liao, MD, PhD · Retina-Vitreous Associates Medical Group
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-05
- Primary Completion
- 2026-12-01
- Completion
- 2026-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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