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Phase 1 Study of C.001 in Retinal Degeneration
A Phase I Single-Center Open-label Study of C.001 in Patients With Significant Retinal Pigment Epithelium Mediated Maculopathy (RMM)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Age ≥18 years * Diagnosis of retinal disease associated with retinal pigment epithelium degeneration (e.g., geographic atrophy or Stargardt disease) * Visual acuity within protocol-defined limits * Stable ocular condition prior to enrollment * Medically suitable for ophthalmic surgery and anesthesia * Willingness to comply with study procedures and follow-up Exclusion Criteria: * Active or prior choroidal neovascularization (CNV) * Recent myocardial infarction or significant uncontrolled cardiovascular disease * Uncontrolled glaucoma * Significant ocular inflammatory disease * Recent intraocular surgery within protocol-defined timeframe * Active systemic infection * Poorly controlled diabetes (e.g., HbA1c \>8.5%) * Participation in another investigational study within 3 months prior to screening
About the study
This is a first-in-human Phase 1 study evaluating the safety and tolerability of C.001 in patients with retinal diseases involving degeneration of the retinal pigment epithelium.
Participants will receive a single administration of C.001 delivered by subretinal injection. The study will evaluate three dose levels in a sequential manner.
The primary objective is to assess the safety of C.001 over a 3-month period following administration. Participants will be followed for up to 12 months to further evaluate safety and explore changes in visual function and retinal structure.
What is being tested
- Injection (biological)
Sponsor: Cellio Therapeutics Inc · Participants: 15 · Started: Apr 7, 2026
Contact the study team
- Clinical Trial Administrator · Phone: 999-999-9999
Official record on ClinicalTrials.gov — NCT07594236
Locations in the U.S.
| California | Retina Vision Consultants, Beverly Hills Palo Alto Medical Foundation, Palo Alto (Not yet recruiting) Retinal Consultants Medical Group, Sacramento (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.