Trials / NCT03963154
Interventional Study of Implantation of hESC-derived RPE in Patients With RP Due to Monogenic Mutation
Underway, not enrolling Phase 1 / Phase 2 Cell therapy
- Sponsor
- Centre d'Etude des Cellules Souches
- Treatment
- Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (RPE)
- Gene
- Not stated
- Conditions
- Retinitis Pigmentosa
- Ages
- 18 Years to 65 Years
- Enrollment
- 7 participants
- Started
- 2019-08-19
- Main results expected
- 2023-06-22
- Results posted
- Not yet
- Record last updated
- 2023-11-28
What the study is testing
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:
Where it runs
France (1)
- •Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts, Paris