A Phase1/2a, Open-Label Study to Evaluate the Safety and Tolerability of RPE Stem Cell-derived RPE (RPESC-RPE) Transplantation as Therapy for Dry Age-related Macular Degeneration (AMD)
Who is this study for? Patients with dry age-related macular degeneration
What treatments are being studied? RPESC-RPE-4W
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Retina Vitreous Associates Medical Group
RECRUITING
Beverly Hills
Spencer Center for Vision Research
RECRUITING
Palo Alto
Michigan
University of Michigan Kellogg Eye Center
RECRUITING
Ann Arbor
Contact Information
Primary
Jeffrey H Stern, M.D., Ph.D.
jeffreystern@luxabiotech.com
05184371111
Time Frame
Start Date: 2022-04-05
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 18
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Luxa Biotechnology, LLC
Collaborators: Regenerative Research Foundation, California Institute for Regenerative Medicine (CIRM), National Institutes of Health (NIH), National Eye Institute (NEI)