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

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ClinicalTrials.gov Identifier: NCT05400590
Recruitment Status : Recruiting
First Posted : June 1, 2022
Last Update Posted : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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
Aniridia 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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Aniridia patients and controls without aniridia
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05400590


Contacts
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Contact: Amélie YAVCHITZ (0)1 48 03 64 54 ext +33 ayavchitz@for.paris

Locations
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France
Hôpital Fondation A. de Rothschild Recruiting
Paris, France, 75019
Contact: Damien GUINDOLET       dguindolet@for.paris   
Contact: Eric GABISON       egabison@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Study Chair: Eric GABISON Hôpital Fondation A. de Rothschild
Principal Investigator: Damien GUINDOLET Hôpital Fondation A. de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT05400590    
Other Study ID Numbers: DGT_2022_2
2022-A00259-34 ( Other Identifier: IDRCB )
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Growth factor rich plasma
Conjunctival impression
Additional relevant MeSH terms:
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Aniridia
Eye Abnormalities
Eye Diseases
Eye Diseases, Hereditary
Iris Diseases
Uveal Diseases
Congenital Abnormalities
Genetic Diseases, Inborn