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

Last updated: April 9, 2025
Sponsor: Luxa Biotechnology, LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Geographic Atrophy

Macular Degeneration

Treatment

RPESC-RPE-4W

Clinical Study ID

NCT04627428
RPESC-RPE-01
U01EY030581
UG3EY031810
  • Ages > 55
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 Karnofskyscale).

  5. Postmenopausal if female (expected to be common for the age limitation), or thefemale partner of a male subject unable to father children.

  6. If male, willing to use barrier and spermicidal contraception during the study.

Exclusion

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 interferewith 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.

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: RPESC-RPE-4W
Phase: 1/2
Study Start date:
April 05, 2022
Estimated Completion Date:
December 01, 2026

Study 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

Connect with a study center

  • University of Michigan Kellogg Eye Center

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

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