Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients (CICASAND)

Keratopathy of patients with aniridia leads to epithelial scarring disorders and a progressive clouding of the cornea linked to this abnormal healing (fibrosis). Treatment with autologous serum is usually undertaken to promote epithelial healing.

However, autologous serum does not prevent the formation of fibrosis, whereas growth factor-rich plasma appears to be associated with a reduction in the in vitro expression of fibrosis markers. This study seeks to compare the in vitro healing and anti-fibrotic properties of autologous serum and growth factor rich plasma from aniridia patients and healthy controls.

Study Overview

• Status: Recruiting
• Conditions: Aniridia
• Intervention / Treatment: Procedure: Peripheral venous blood sample; Procedure: Conjunctival impression

Detailed Description

Blood collection from aniridia patients and healthy controls, half of which will be used to make autologous serum and the other half to make growth factor rich plasma, used for in vitro studies.

A conjunctival impression will also be taken at the inclusion of the patients.

• Study Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: Amélie YAVCHITZ; Phone Number: +33 (0)1 48 03 64 54; Email: ayavchitz@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation A. de Rothschild
    • Contact: Eric GABISON; Email: egabison@for.paris
    • Contact: Damien GUINDOLET; Email: dguindolet@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Aniridia patients and controls without aniridia

Description

Inclusion Criteria:

For patients with aniridia:

• With aniridia
• Patient weighing more than 40 kg
• If the patient is being treated with autologous serum, a delay of 8 weeks after the last blood collection
• If a blood donation has been made, a delay of 8 weeks must be respected after the last donation

For controls:

• Non-aniridia (no clinical signs)
• Weighing more than 40 kg
• Matched to a case for sex and age +/-5 years
• No known diabetes
• If a blood donation has been made, a delay of 8 weeks must be respected after the latter

Exclusion Criteria:

• Person benefiting from a legal protection measure
• Pregnant or breastfeeding woman

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case patients with aniridia	Procedure: Peripheral venous blood sample; 2.5% of body weight; Procedure: Conjunctival impression; Collection of the most superficial conjunctival epithelial cells (desquamating) in a non- or minimally invasive, quick and almost painless way, for a biological analysis of ocular surface diseases. Application of a filter paper on the bulbar conjunctiva, under local anesthesia.
Control patients without aniridia	Procedure: Peripheral venous blood sample; 2.5% of body weight; Procedure: Conjunctival impression; Collection of the most superficial conjunctival epithelial cells (desquamating) in a non- or minimally invasive, quick and almost painless way, for a biological analysis of ocular surface diseases. Application of a filter paper on the bulbar conjunctiva, under local anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In vitro comparison of the corneal cell healing properties of autologous serum and plasma enriched with growth factors from blood of aniridia patients	The corneal cell healing properties are evaluated by the time to reach confluence (number of hours) of epithelial cells, using a standardized wound healing assay (Incucyte, Essenbioscience). The corneal cell healing properties will be comparated between autologous serum, and plasma enriched with growth factors from blood of aniridia patients	Sampling done at baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Study Chair: Eric GABISON, Hôpital Fondation A. de Rothschild; Principal Investigator: Damien GUINDOLET, Hôpital Fondation A. de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Growth factor rich plasma; Conjunctival impression
• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Eye Abnormalities; Genetic Diseases, Inborn; Uveal Diseases; Eye Diseases, Hereditary; Iris Diseases; Aniridia
• Other Study ID Numbers: DGT_2022_2; 2022-A00259-34 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No