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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05400590
Acronym
CICASAND
Enrollment
24
Registered
2022-06-01
Start date
2023-05-15
Completion date
2026-05-31
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aniridia

Keywords

Growth factor rich plasma, Conjunctival impression

Brief 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.

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.

Interventions

2.5% of body weight

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.

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
In vitro comparison of the corneal cell healing properties of autologous serum and plasma enriched with growth factors from blood of aniridia patientsSampling done at baselineThe 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

Countries

France

Contacts

Primary ContactAmélie YAVCHITZ
ayavchitz@for.paris(0)1 48 03 64 54

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026