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

Background: Vulvar lichen sclerosus (VLS) is a chronic inflammatory dermatosis that impairs quality of life through symptoms like itching, pain, and atrophy, and has limited response to conventional corticosteroid therapy.

Objectives: 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: This prospective, open-label study 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 (CSS), itching (5D Itch Scale), quality of life (Skindex-29), and sexual function (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 = 0.0025), CSS Signs (from 5.79 to 2.00, p = 0.0014), and Itching 5D (from 6.82 to 2.35, p = 0.0136) were observed at 12 months. Quality of life improved (Skindex-29: from 42.88 to 24.82, p = 0.0313). FSFI scores showed non-significant improvement. Histologically, a marked reduction in stromal hyalinization (p = 0.0036) and CD3+ T-cell infiltration (p = 0.0068), along with increased microvascular density (p = 0.0121), 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.