CICASAND: Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- In vitro comparison of the corneal cell healing properties of autologous serum and plasma enriched with growth factors from blood of aniridia patients [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
Eligibility Criteria
Criteria
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:
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Non-aniridia (no clinical signs)
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Weighing more than 40 kg
-
Matched to a case for sex and age +/-5 years
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No known diabetes
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If a blood donation has been made, a delay of 8 weeks must be respected after the latter
Exclusion Criteria:
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Person benefiting from a legal protection measure
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Pregnant or breastfeeding woman
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Fondation A. de Rothschild | Paris | France | 75019 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- DGT_2022_2
- 2022-A00259-34