Interventional Study of Implantation of hESC-derived RPE in Patients With RP Due to Monogenic Mutation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Retinitis Pigmentosa
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: Open-label studyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
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...
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.
Tracking Information
- NCT #
- NCT03963154
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Stéphane BERTIN, MD Centre des 15-20
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