Using Platelet Rich Plasma from Cord Blood to Treat Vulvar Lichen Sclerosus
Use of Platelet Rich Plasma from Cord Blood Vs Placebo in the Treatment of Vulvar Lichen Sclerosus
This study is testing if using Platelet Rich Plasma from cord blood can help women with Vulvar Lichen Sclerosus feel better when other treatments haven't worked.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, Milan) |
| Trial ID | NCT06661382 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Platelet Rich Plasma (PRP) derived from cord blood in treating Vulvar Lichen Sclerosus (VLS), a condition that causes significant discomfort in women. The study aims to provide an alternative treatment option for patients who do not respond adequately to traditional corticosteroid therapies. Participants will receive infiltrative treatment with CB-PRP, and their symptoms will be monitored over time to assess improvements in quality of life. The trial is designed to evaluate both the safety and efficacy of this regenerative medicine approach.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with Vulvar Lichen Sclerosus who are in good health and can provide informed consent.
Not a fit: Patients who are pregnant, have coagulopathies, or have undergone previous vulvar surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms and improve the quality of life for women suffering from Vulvar Lichen Sclerosus.
How similar studies have performed: While the use of PRP in various medical fields has shown promise, this specific application for Vulvar Lichen Sclerosus is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women with VLS (clinical/histological diagnosis) * good health conditions * written informed consent signed and dated by the patient Exclusion Criteria: * pregnancy * coagulopathies, platelet disorders, cardiovascular and/or respiratory diseases * ongoing major infections * previous vulvar surgery (e.g., lipostructure and/or previous PRP)
Where this trial is running
Milan, Milan
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico — Milan, Milan, Italy (Recruiting)
Study contacts
- Principal investigator: veronica Boero, MD — Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study coordinator: Veronica Boero, MD
- Email: veronica.boero@policlinico.mi.it
- Phone: 0255032318
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.