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

Retinitis Pigmentosa Clinical Trial

— SiCord  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636853
• Other study ID #: 3417
• Status: Completed
• Phase: Phase 3
• Start date: December 23, 2020
• Est. completion date: December 2, 2021

Study information

• Verified date: December 2020
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Age-related Macular Degeneration
• Macular Degeneration
• Retinitis
• Retinitis Pigmentosa

Intervention

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.

Locations

Country	Name	City	State
Italy	Alfonso Savastano	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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