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CB-PRP in Retinitis Pigmentosa (SiCord)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04636853
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description
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Brief Summary:

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

Detailed 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-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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Alfonso Savastano, MD +390630154928 alfonso.savastano@policlinicogemelli.it
Contact: Alfonso Savastano +390630154928 alfonso.savastano@policlinicogemelli.it

Locations
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Italy
Alfonso Savastano Recruiting
Rome, Italy, 00168
Contact: Alfonso Savastano    +390630154928    alfonso.savastano@policlinicogemelli.it   
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
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Principal Investigator: Alfonso Savastano Fondazione Policlinico Universitario A. Gemelli, IRCCS
More Information
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Publications of Results:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
Cord blood plateled-rich plasma
Retinitis pigmentosa
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn