ACE Reno™ Clinical Trial
- Title: ACE Retino™ (Pico Cell Matrix) for Retinal Regeneration in Pediatric Corneal Opacity Study
- Clinical Trial ID: NCT06787482
- Product: ACE Retino™, a Pico Cell Matrix-derived formulation for ocular tissue regeneration.
Background
Retinal degeneration, corneal opacities, and other ocular disorders represent significant challenges in pediatric ophthalmology and visual rehabilitation. Our proprietary Pico Cell Matrix technology processes tissue-derived peptides into nanometer-scale and picometer-scale fragments, intended to support cellular repair and regenerative outcomes. ACE Retino™ applies this technology to ocular tissues to support the regeneration of the retina, optic nerve, and related structures
Study Purpose
This clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of ACE Retino™ in young patients with corneal opacity and associated retinal and/or optic nerve involvement. The aim is also to gather data to support the further development of the formulation for retinal degenerative conditions.
Key Features of the Trial
- Intervention: Administration of ACE Retino™ (dose and route as specified in the protocol) in pediatric subjects with corneal opacity and retinal/optic involvement.
- Primary Outcome Measures: Safety endpoints (adverse events, tolerability) and vision/retinal function parameters (e.g., visual acuity, retinal imaging, electrophysiology) over the treatment and follow-up period.
- Design: Multi-arm/phase (as specified) clinical investigation including pediatric patients, conducted under Good Clinical Practice standards.
- Enrollment Criteria: Children with documented corneal opacity and retinal/optic nerve involvement, meeting inclusion and exclusion criteria defined in the trial protocol.
- Follow-Up: Subjects will undergo serial assessments of ocular structure and function, safety monitoring, and imaging over the defined study period.
Why This Trial Matters
- It marks the first in-human investigation of ACE Retino™ in a pediatric ocular pathology setting.
- If successful, ACE Retino™ may open a novel non-surgical/adjunctive option for children with corneal/retinal-optic disorders—potentially reducing lifetime visual disability.
- Conducting this trial signals our commitment to rigorous clinical evaluation, transparency, and evidence-based advancement in regenerative ophthalmology.
Disclosure & Notes
- The study is conducted under ethical oversight and in accordance with Good Clinical Practice (GCP).
- ACE Retino™ is currently under clinical investigation; it is not yet approved for general treatment of retinal or corneal conditions.
- Participants and legal guardians should carefully review the informed consent/assent documentation, including risks, benefits, and alternatives.
- The trial status (e.g., recruiting, active, completed) may change; please refer to the clinical registry for updates.