CB-PRP in Retinitis Pigmentosa and Dry Age-related Macular Degeneration (SiCord)

January 9, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Cord Blood Platelet-rich Plasma (CB-PRP) in Retinitis Pigmentosa and Dry Age-related Macular Degeneration

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  • 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
  • Electroretinogram (ERG)
  • Visually evoked potential (VEP)
  • contrast sensitivity (MARS tables)
  • Goldmann perimetry

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Alfonso Savastano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Retinal dystrophies with compromised rods (only for RP patients)
  • Visual Field (Manual Goldmann) V / 4e < 30 ° (only for RP patients)
  • Best corrected visual acuity > Light perception
  • Known genotype
  • No or minimal opacity of ocular media
  • No concomitant ocular (eg glaucoma, amblyopia)
  • Dry Age-related Macular Degeneration (Geographic type)

Exclusion Criteria:

  • Age<18 years
  • Pregnancy
  • Previous inflammatory / infectious events involving the eyes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Alfonso Savastano, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2020

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 2, 2021

Study Registration Dates

First Submitted

November 14, 2020

First Submitted That Met QC Criteria

November 14, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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