Clinical and Histopathological Investigation of Stromal Vascular Fraction and Nanofat in Vulvar Lichen Sclerosus

Abstract

Background Vulvar lichen sclerosus (VLS) is a chronic inflammatory dermatosis that impairs the quality of life through symptoms such as itching, pain, and atrophy, and has limited response to conventional corticosteroid therapy.Objectives The authors of this study aim to evaluate the safety and efficacy of the Lichen-SVF protocol, a regenerative treatment combining nanofat and mechanically isolated stromal vascular fraction (SVF) for moderate-to-severe VLS.Methods In this prospective, open-label study, the authors included 18 women with moderate-to-severe VLS and participants ranged from 24 to 81 years old, reflecting the broad clinical spectrum of this condition. Each received a single treatment involving intra- and subdermal injection of autologous nanofat (40 cc) and SVF (2-3 cc) into vulvar and perianal regions. Clinical follow-up occurred at 1, 3, 6, and 12 months. Symptom severity (clinical score system, CSS), itching (5D Itch Scale), quality of life (Skindex-29), and sexual function (Female Sexual Function Index, FSFI) were assessed using validated scales. Pre- and 12-month biopsies were analyzed histologically and immunohistochemically for markers such as stromal hyalinization, microvascular density, and T-cell infiltration.Results Statistically significant reductions in CSS symptoms (from 20.12 to 4.71, P = .0025), CSS signs (from 5.79 to 2.00, P = .0014), and Itching 5D (from 6.82 to 2.35, P = .0136) were observed at 12 months. The quality of life improved (Skindex-29: from 42.88 to 24.82, P = .0313). FSFI scores showed nonsignificant improvement. Histologically, a marked reduction in stromal hyalinization (P = .0036) and CD3+ T-cell infiltration (P = .0068), along with increased microvascular density (P = .0121), confirmed regenerative effects. No serious adverse events occurred.Conclusions The Lichen-SVF protocol offers a safe and effective regenerative option for women with VLS who do not respond to standard treatments. As low-dose corticosteroids were maintained throughout follow-up, the protocol should be viewed as a complementary approach that enhances, rather than replaces, conventional therapy.