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

Aniridia Clinical Trial

— CICASAND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400590
• Other study ID #: DGT_2022_2
• Secondary ID: 2022-A00259-34
• Status: Recruiting
• Start date: May 15, 2023
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie YAVCHITZ
• Phone: (0)1 48 03 64 54
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aniridia

Intervention

Procedure:
• Peripheral venous blood sample
2.5% of body weight
• 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.

Locations

Country	Name	City	State
France	Hôpital Fondation A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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