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NCT Number: NCT05400590

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Fondation A. de Rothschild

Paris, 75019, France

Location status: Recruiting

Location contact

Damien GUINDOLET

CONTACT

[email protected]

Eric GABISON

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For patients with aniridia:

  • With aniridia
  • Patient weighing more than 43 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 43 kg
  • Matched to a case for sex and age +/-10 years
  • No known diabetes
  • If a blood donation has been made, a delay of 8 weeks must be respected after the latter

Exclusion criteria

  • Insufficient sample volume
  • No conjunctival print
  • HBV, HCV, HIV serology positive
  • Aniridia not genetically confirmed for cases For each patient excluded, a new patient will be included in order to maintain the number of patients required for data analysis.

Treatment and study plan

Peripheral venous blood sample

Procedure

2.5% of body weight

Conjunctival impression

Procedure

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.

Primary outcomes

  1. In vitro comparison of the corneal cell healing properties of autologous serum and plasma enriched with growth factors from blood of aniridia patients

    Time frame: Sampling done at baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Amélie YAVCHITZ

CONTACT

[email protected]

(0)1 48 03 64 54 ext. +33

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: CICASAND

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2022
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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