Phase 1 Study of C.001 in Retinal Degeneration
Cellio Therapeutics Inc · with California Institute for Regenerative Medicine (CIRM) · NCT07594236
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 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1
- Target enrollment
- 15
- US sites recruiting
- 1
- Study start
- April 7, 2026
- Record last updated
- August 17, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Injection
Conditions: Geographic Atrophy; Stargardt Disease; RPE-mediated Maculopathy; 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
- 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
Recruiting US locations
Retina Vision Consultants
Beverly Hills, CA 90210
Site contact: Pradeep Prasad, MD · (310) 269-8565 · trials@celliotherapeutics.com
Study contacts (from the official record)
- Clinical Trial Administrator · 999-999-9999 · trials@celliotherapeutics.com
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