Clinical Research Directory
Browse clinical research sites, groups, and studies.
Interventional Study of Implantation of hESC-derived RPE in Patients With RP Due to Monogenic Mutation
Sponsor: Centre d'Etude des Cellules Souches
Summary
Phase I/II open-label, safety, tolerability and preliminary efficacy study of implantation into one eye of hESC-derived RPE (Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (RPE)) in patients with retinitis pigmentosa due to monogenic mutation. Study non randomized single group assignment consisting in 2 sequential cohorts of patients: * First cohort of 2 patients with very advanced loss of visual acuity (legally blind) * Second cohort of 10 patients with less advanced loss of visual acuity:
Official title: STREAM: A Phase 1/2, Open-label, Safety, Tolerability and Preliminary Efficacy Study of Implantation Into One Eye of hESC-derived RPE in Patients With Retinitis Pigmentosa Due to Monogenic Mutation
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
7
Start Date
2019-08-19
Completion Date
2026-12-15
Last Updated
2023-11-28
Healthy Volunteers
No
Conditions
Interventions
Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (RPE)
Implantation into one eye of hESC-derived RPE (Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (RPE))
Locations (1)
•Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts
Paris, France