CompletedPhase 1/2

Stem Cell Therapy for Outer Retinal Degenerations

Brazil15 participantsStarted 2015-08

Plain-language summary

This study is a Phase I/II , open label,non randomized, prospective study to determine the safety of human embryonic stem cell derived Retinal pigmented epithelium (hESC RPE) sub retinal injections versus hESC RPE seeded on a polymeric substrate implanted in the sub retinal space,

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with AMD ( Dry , Wet after failure of treatment, disciform scars) * Patients with Stargardt's Disease BCVA on the selected eye: worse than 20/200 Exclusion Criteria: * Other ophthalmological diseases( Glaucoma, Diabetic Retinopathy, Previous retinal surgery, uveitis) * Systemic diseases with contraindication for surgical procedures with local anaesthesia

What they're measuring

Incidence of Treatment-Emergent Adverse Events of sub retinal implantation of stem cell derived retinal pigmented epithelium in the sub retinal space.

Timeframe: 1 year

Trial details

NCT IDNCT02903576

SponsorFederal University of São Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01

View on ClinicalTrials.gov More Age Related Macular Degeneration trials