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

  • STATUS
    Recruiting
  • End date
    Sep 27, 2025
  • participants needed
    18
  • sponsor
    Luxa Biotechnology, LLC
Updated on 4 October 2022

Summary

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

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

Details
Condition Dry Age-related Macular Degeneration
Treatment RPESC-RPE-4W
Clinical Study IdentifierNCT04627428
SponsorLuxa Biotechnology, LLC
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of dry AMD
Ability to understand and give informed consent
Adult male or female >55 years of age
Medically suitable to undergo vitrectomy and subretinal injection (>60% on Karnofsky scale)
Postmenopausal if female (expected to be common for the age limitation), or the female partner of a male subject unable to father children
If male, willing to use barrier and spermicidal contraception during the study

Exclusion Criteria

Allergy or hypersensitivity to dilation drops or fluorescein
Active major medical conditions limiting ability to participate in the study
Active malignancy or treatment with chemotherapy
Systemic immunosuppressant therapy within past six months
History of toxoplasmosis, retinal histoplasmosis or tuberculosis
Receipt of investigational product (IP) in a clinical trial within prior six months
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
Pregnant or nursing females
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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