NCT04627428RecruitingPhase 1/2
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)
Source: ClinicalTrials.gov · Last updated 15 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 1 Nov 2020
- Start date
- 5 Apr 2022
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Luxa Biotechnology, LLC
- Diseases
- Macular degeneration
- NCT number
- NCT04627428
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 18
- From 5 Apr 2022 to the primary completion date, 1 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active malignancy or treatment with chemotherapy.
- Systemic immunosuppressant therapy within past six months.
- Receipt of investigational product (IP) in a clinical trial within prior six months.
Other illness
- Allergy or hypersensitivity to dilation drops or fluorescein.
- Active major medical conditions limiting ability to participate in the study.
- History of toxoplasmosis, retinal histoplasmosis or tuberculosis.
- 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.
Other
- Pregnant or nursing females.
Who the study is looking for
- 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.
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Kellogg Eye Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Retina-Vitreous Associates Medical Group Coordinator of this site? Confirm its status | Beverly Hills | United States | Recruiting |
| Spencer Center for Vision Research Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.