CB-PRP in Retinitis Pigmentosa
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Retinitis Pigmentosa
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
All patients underwent genetic evaluation and they reported different types of mutations that induce anatomic-functional impairment of the rods. After selecting the patients to be enrolled, the study will proceed with the vitrectomy surgery and a subretinal injection of umbilical cord blood platelet...
All patients underwent genetic evaluation and they reported different types of mutations that induce anatomic-functional impairment of the rods. After selecting the patients to be enrolled, the study will proceed with the vitrectomy surgery and a subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) provided by the Umbilical Cord Bank according to the procedures provided for by the current legislation on blood components for non-transfusion use. A complete ophthalmological examination will be performed at 1, 3, 6 and 12 months. They will include: Anterior segment biomicroscopy direct and indirect ophthalmoscopy ETDRS visual acuity assessment intraocular pressure measurement optical coherence tomography (OCT) OCT Angiography (OCTA) The following assessments will be performed at baseline and at 6 and 12 months. Microperimetry ERG (elettroretinogramma) - PEV (potenziali evocati visivi) contrast sensitivity (MARS tables) Goldmann perimetry The some morpho-functional data will also be collected in the contralateral eye and used as control group. To ensure the best safety for the patient, the first 5 eyes will be separated by a minimum of 20 days in order to observe the post-surgical evolution.
Tracking Information
- NCT #
- NCT04636853
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Alfonso Savastano Fondazione Policlinico Universitario A. Gemelli, IRCCS