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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Luxa Biotechnology, LLC
Study ID
NCT04627428
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Dry Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RPESC-RPE-4W — BIOLOGICAL
    RPESC-RPE-4W

Study Details

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

Key Dates

Start date
Apr 5, 2022
Status verified
Oct 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 50,000 cells
    Six patients will receive single dose of 50,000 RPESC-RPE-4W cells in the eye.
  • Experimental: 150,000 cells
    Six patients will receive single dose of 150,000 RPESC-RPE-4W cells in the eye.
  • Experimental: 250,000 cells
    Six patients will receive single dose of 250,000 RPESC-RPE-4W cells in the eye.

Primary Outcome Measure

Safety and tolerability of RPESC-RPE-4W transplantation [ Time Frame: 24 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Retina Vitreous Associates Medical GroupBeverly HillsCalifornia90211
David S Liao, MD, PhD
Spencer Center for Vision ResearchPalo AltoCalifornia94303
Theodore Leng, MD, FACS
University of Michigan Kellogg Eye CenterAnn ArborMichigan48105
Rajesh C Rao, M.D.

Find similar trials in Beverly Hills, CA

By research site
Retina Vitreous Associates Medical Group· Beverly Hills, CASpencer Center for Vision Research· Palo Alto, CAUniversity of Michigan Kellogg Eye Center· Ann Arbor, MI

Related Studies