NCT07594236 Phase 1 Study of C.001 in Retinal Degeneration
| NCT ID | NCT07594236 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Cellio Therapeutics Inc |
| Condition | Geographic Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-04-07 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2026-04-07 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Frequently Asked Questions
Who can join the NCT07594236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Geographic Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07594236 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07594236 currently recruiting?
Yes, NCT07594236 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cellio Therapeutics Inc to inquire about joining.
Where is the NCT07594236 trial being conducted?
This trial is being conducted at Beverly Hills, United States.
Who is sponsoring the NCT07594236 clinical trial?
NCT07594236 is sponsored by Cellio Therapeutics Inc. The trial plans to enroll 15 participants.