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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age55+
SponsorLuxa Biotechnology, LLC

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • RPESC-RPE-4W

Treatment groups

18 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Luxa Biotechnology, LLC

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Eye Institute (NEI)

Collaborator

Regenerative Research Foundation

Collaborator

California Institute for Regenerative Medicine (CIRM)

Collaborator