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Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)
RecruitingPhase 1/2
A Phase1/2a, Open-Label Study to Evaluate the Safety and Tolerability of RPE Stem Cell-derived RPE (RPESC-RPE) Transplantation as Therapy for Dry Age-related Macular Degeneration (AMD)
Who can join
Ages 55 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Clinical diagnosis of dry AMD. 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: 1. Allergy or hypersensitivity to dilation drops or fluorescein. 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.
About the study
The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
What is being tested
- RPESC-RPE-4W (biological)
Sponsor: Luxa Biotechnology, LLC · Participants: 18 · Started: Apr 5, 2022
Contact the study team
- Jeffrey H Stern, M.D., Ph.D. · Phone: 05184371111
Official record on ClinicalTrials.gov — NCT04627428
Locations in the U.S.
| California | Retina Vitreous Associates Medical Group, Beverly Hills Spencer Center for Vision Research, Palo Alto |
| Michigan | University of Michigan Kellogg Eye Center, Ann Arbor |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.