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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Affected Individual | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) morphological changes | Differences in structural optical coherence tomography (OCT) and OCT Angiography (OCTA) images | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfonso Savastano | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfonso Savastano | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30858959 | Result | Valentini CG, Nuzzolo ER, Bianchi M, Orlando N, Iachininoto MG, Pinci P, Teofili L. Cord Blood Platelet Lysate: In Vitro Evaluation to Support the Use in Regenerative Medicine. Mediterr J Hematol Infect Dis. 2019 Jan 1;11(1):e2019021. doi: 10.4084/MJHID.2019.021. eCollection 2019. | |
| 39149709 | Derived | Rizzo S, Savastano MC, Falsini B, Bernardinelli P, Boselli F, De Vico U, Carla MM, Giannuzzi F, Fossataro C, Gambini G, Crincoli E, Ferrara S, Ripa M, Killian R, Rizzo C, Valentini CG, Orlando N, Placidi G, Teofili L, Savastano A. Safety Results for Geographic Atrophy Associated with Age-Related Macular Degeneration Using Subretinal Cord Blood Platelet-Rich Plasma. Ophthalmol Sci. 2024 Jan 24;4(6):100476. doi: 10.1016/j.xops.2024.100476. eCollection 2024 Nov-Dec. |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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|
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |