A Phase 3 interventional study of Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) in Retinitis Pigmentosa and Dry Age-related Macular Degeneration, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Phase 3, Interventional, and Treatment
The study will provides the enrollment of patients with genetic retinal dystrophies with primary rod impairment and dry age-related macular degeneration (Geographic type) A subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) will be performed only in one eye, the other eye will be considered as a control group.
A complete morpho-functional ophthalmological evaluation will be performed in all patients at each control.
All patients underwent genetic evaluation and they reported different types of mutations that induce anatomic-functional impairment of the rods.
Patients affected by bilateral dry age-related macular degeneration (Geographic type) will be recruited as well.
After selecting the patients to be enrolled, the study will proceed with the vitrectomy surgery and 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:
The following assessments will be performed at baseline and at 6 and 12 months.
Some morpho-functional data will also be collected in the contralateral eye and used as the 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.
273 studies on the registry are indexed under Retinitis Pigmentosa; 71 are open to participants now.
This study's enrollment of 20 is below the median of 27 across 177 interventional studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) will be performed only in one eye, the other eye will be considered as a control group.
Biological: Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP)
A subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) will be performed only in one eye, the other eye will be considered as a control group. A complete morpho-functional ophthalmological evaluation will be performed in all patient at each control.
Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) morphological changes
Differences in structural optical coherence tomography (OCT) and OCT Angiography (OCTA) images
Time frame: 3 years
Plan to share: No
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS →