Alfonso Savastano
Rome, 00168, Italy
NCT Number: NCT04636853
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 3
Rome, 00168, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
A complete morpho-functional ophthalmological evaluation will be performed in all patient at each control.
Time frame: 3 years
Differences in structural optical coherence tomography (OCT) and OCT Angiography (OCTA) images
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Cord Blood Platelet-rich Plasma (CB-PRP) in Retinitis Pigmentosa and Dry Age-related Macular Degeneration
Acronym: SiCord
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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