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ACTIVE NOT RECRUITING
NCT03963154
PHASE1/PHASE2

Interventional Study of Implantation of hESC-derived RPE in Patients With RP Due to Monogenic Mutation

Sponsor: Centre d'Etude des Cellules Souches

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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