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NCT04627428PHASE1, PHASE2Recruiting

Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)

Luxa Biotechnology, LLC

Start Date

4/5/2022

Completion Date

12/1/2026

Summary

The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.

Detailed Description

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

Eligibility Criteria

Age Range: 55 years to No maximum

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.

Interventions

BIOLOGICAL

RPESC-RPE-4W

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Conditions

Dry Age-related Macular Degeneration

Locations

Retina Vitreous Associates Medical Group

Beverly Hills, California 90211

United States

Spencer Center for Vision Research

Palo Alto, California 94303

United States

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan 48105

United States