Open-label prospective cohort evaluating stem cell enriched lipotransfer as the treatment for vulvar lichen sclerosus

Abstract Introduction Vulval lichen sclerosus (VLS) is a chronic skin disease characterised by pain, itching, apareunia, loss of vulval architecture and scarring, resulting in poor quality of life. Stem cell enriched lipotransfer has been proposed as a treatment for patients with VLS experiencing scarring and fibrosis. Methods This study was an open-label prospective cohort aiming to assess the effectiveness of stem cell enriched lipotransfer in improving signs, symptoms and quality of life of patients with VLS. Patients were recruited from the local clinic. All patients received at least one treatment. Validated outcome measures were used to prospectively assess the sexual function, quality of life, and symptoms. Vulvar Architecture Severity Scale (VASS) was used to report physician-assessed disease signs. Results Fifty-nine patients were included. The average age was 52.9 yrs. The mean follow-up was 11.9 months. The most common symptoms included itching and pain. The most reported signs were loss of vulvar architecture and scarring. The median number of procedures was 2. The mean volume of fat injected was 11.38 cc. Patients reported a reduction in itching and burning. Lipotransfer also resulted in better sexual function and decreased distress associated with sexuality. Anxiety due to VLS was reduced by the treatment. The VASS score varied by region but there was an improvement in all affected areas. Conclusion Stem cell enriched lipotransfer improved signs, symptoms and quality of life of VLS patients in this cohort. A randomised controlled trial is needed to demonstrate its efficacy, safety and the underlying molecular mechanism of action.