Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)
NCT ID: NCT04627428
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2022-04-05
2026-12-01
Brief Summary
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Detailed Description
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This first-in-human Phase 1/2a open-label dose-escalation interventional study plans to enroll a total of 18 subjects
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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50,000 cells
Six patients will receive single dose of 50,000 RPESC-RPE-4W cells in the eye.
RPESC-RPE-4W
RPESC-RPE-4W
150,000 cells
Six patients will receive single dose of 150,000 RPESC-RPE-4W cells in the eye.
RPESC-RPE-4W
RPESC-RPE-4W
250,000 cells
Six patients will receive single dose of 250,000 RPESC-RPE-4W cells in the eye.
RPESC-RPE-4W
RPESC-RPE-4W
Interventions
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RPESC-RPE-4W
RPESC-RPE-4W
Eligibility Criteria
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Inclusion Criteria
2. Ability to understand and give informed consent.
3. Adult male or female \>55 years of age.
4. Medically suitable to undergo vitrectomy and subretinal injection (\>60% on Karnofsky scale).
5. Postmenopausal if female (expected to be common for the age limitation), or the female partner of a male subject unable to father children.
6. If male, willing to use barrier and spermicidal contraception during the study.
Exclusion Criteria
2. Active major medical conditions limiting ability to participate in the study.
3. Active malignancy or treatment with chemotherapy.
4. Systemic immunosuppressant therapy within past six months.
5. History of toxoplasmosis, retinal histoplasmosis or tuberculosis.
6. Receipt of investigational product (IP) in a clinical trial within prior six months.
7. Any other medical condition, which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.
8. Pregnant or nursing females.
55 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Eye Institute (NEI)
NIH
Regenerative Research Foundation
UNKNOWN
California Institute for Regenerative Medicine (CIRM)
OTHER
Luxa Biotechnology, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Rajesh C Rao, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Kellogg Eye Center
Theodore Leng, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Spencer Center for Vision Research at Stanford University
David S Liao, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Retina-Vitreous Associates Medical Group
Locations
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Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Spencer Center for Vision Research
Palo Alto, California, United States
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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David S Liao, MD, PhD
Role: primary
Theodore Leng, MD, FACS
Role: primary
Rajesh C Rao, M.D.
Role: primary
Other Identifiers
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