Comparing healing effects of growth factor-rich plasma and autologous serum in aniridia patients
Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients
This study is testing whether growth factor-rich plasma or autologous serum helps heal the eyes better in people with aniridia, a condition that causes corneal scarring.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Trial ID | NCT05400590 on ClinicalTrials.gov |
What this trial studies
This study investigates the healing properties of growth factor-rich plasma versus autologous serum in patients with aniridia, a condition that leads to corneal scarring and clouding. Blood samples will be collected from both aniridia patients and healthy controls, with half used to create autologous serum and the other half for growth factor-rich plasma. The study aims to evaluate the in vitro healing and anti-fibrotic effects of these treatments by analyzing conjunctival impressions. The goal is to determine which treatment may better promote epithelial healing and reduce fibrosis.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with aniridia who meet specific weight and health criteria.
Not a fit: Patients with insufficient sample volume or those with unconfirmed genetic aniridia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for improving corneal healing in aniridia patients.
How similar studies have performed: While the use of autologous serum is common, the specific comparison of growth factor-rich plasma in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Paris
- Hôpital Fondation A. de Rothschild — Paris, France (Recruiting)
Study contacts
- Principal investigator: Damien GUINDOLET — Hôpital Fondation A. de Rothschild
- Study coordinator: Amélie YAVCHITZ
- Email: ayavchitz@for.paris
- Phone: (0)1 48 03 64 54
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.