Retinitis Pigmentosa Clinical Trial
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
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:
Monocentric study (Hospital of 15-20 at Paris) of duration of 106 weeks. At total,12 evaluable patients will be enrolled and assigned in 2 cohorts as described above in brief summary. Expected follow-up for one patient is about 64 weeks including 8 weeks of screening and baseline period and 56 weeks of follow-up after implantation of hESC-derived RPE. After 56 weeks of follow-up, patients will be enrolled in a long term follow-up study during 4 additional years. The primary objective is to assess safety and tolerability of implantation of the Investigational Medecinal Product (ISTEM-01) in patients with retinitis pigmentosa. Secondary objectives are: - To evaluate the placement and position of the patch - To assess preliminary efficacy based on: - Evaluation of visual function - Eye fundus - Evaluation of photoreceptor survival Assessment of visual function by Diagnosys-Full-field stimulus threshold (D-FST) is the only exploratory objective. ;
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