Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)
Luxa Biotechnology, LLC · with National Institutes of Health (NIH), National Eye Institute (NEI) · NCT04627428
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 55+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1, Phase 2
- Target enrollment
- 18
- US sites recruiting
- 3
- Study start
- April 5, 2022
- Record last updated
- October 15, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
Being studied: RPESC-RPE-4W
Conditions: Dry Age-related Macular Degeneration
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- History of toxoplasmosis, retinal histoplasmosis or tuberculosis.
- Receipt of investigational product (IP) in a clinical trial within prior six months.
- 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.
- Pregnant or nursing females.
Recruiting US locations
Retina Vitreous Associates Medical Group
Beverly Hills, CA 90211
Site contact: David S Liao, MD, PhD
Spencer Center for Vision Research
Palo Alto, CA 94303
Site contact: Theodore Leng, MD, FACS
University of Michigan Kellogg Eye Center
Ann Arbor, MI 48105
Site contact: Rajesh C Rao, M.D.
Study contacts (from the official record)
- Jeffrey H Stern, M.D., Ph.D. · 05184371111 · jeffreystern@luxabiotech.com
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