Trials / Recruiting
RecruitingNCT04627428
Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)
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)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Luxa Biotechnology, LLC · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
Detailed 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RPESC-RPE-4W | RPESC-RPE-4W |
Timeline
- Start date
- 2022-04-05
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2020-11-13
- Last updated
- 2025-10-15
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04627428. Inclusion in this directory is not an endorsement.