CB-PRP in Retinitis Pigmentosa (SiCord)
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ClinicalTrials.gov Identifier: NCT04636853 |
Recruitment Status :
Recruiting
First Posted : November 19, 2020
Last Update Posted : December 17, 2020
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The study will provides the enrollment of patients with genetic retinal dystrophies with primary rod impairment.
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Retinitis Pigmentosa | Biological: Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Cord Blood Platelet-rich Plasma (CB-PRP) in Retinitis Pigmentosa |
Estimated Study Start Date : | December 23, 2020 |
Estimated Primary Completion Date : | December 1, 2021 |
Estimated Study Completion Date : | December 1, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Affected Individual
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 [ Time Frame: 3 years ]Differences in structural optical coherence tomography (OCT) and OCT Angiography (OCTA) images

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Retinal dystrophies with compromised rods
- Visual Field (Manual Goldmann) V / 4e < 30 °
- Best corrected visual acuity > Light perception
- Known genotype
- No or minimal opacity of ocular media
- No concomitant ocular (eg glaucoma, amblyopia)
Exclusion Criteria:
- Age<18 years
- Pregnancy
- Previous inflammatory / infectious events involving the eyes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636853
Contact: Alfonso Savastano, MD | +390630154928 | alfonso.savastano@policlinicogemelli.it | |
Contact: Alfonso Savastano | +390630154928 | alfonso.savastano@policlinicogemelli.it |
Italy | |
Alfonso Savastano | Recruiting |
Rome, Italy, 00168 | |
Contact: Alfonso Savastano +390630154928 alfonso.savastano@policlinicogemelli.it |
Principal Investigator: | Alfonso Savastano | Fondazione Policlinico Universitario A. Gemelli, IRCCS |
Responsible Party: | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
ClinicalTrials.gov Identifier: | NCT04636853 |
Other Study ID Numbers: |
3417 |
First Posted: | November 19, 2020 Key Record Dates |
Last Update Posted: | December 17, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cord blood plateled-rich plasma Retinitis pigmentosa |
Retinitis Retinitis Pigmentosa Retinal Diseases Eye Diseases |
Eye Diseases, Hereditary Retinal Dystrophies Retinal Degeneration Genetic Diseases, Inborn |