Liquenia-SVF Clinical Trial: The research that originated the protocol
The Liquenia® Treatment is the result of a clinical research program initiated in 2017 at the La Fe University Hospital in Valencia. This page documents its design, methodology, and main results.
Why this trial was designed
Vulvar lichen sclerosus lacks therapeutic options that act on accumulated tissue damage. Topical corticosteroids—the first line of treatment according to international guidelines—effectively control inflammation and symptoms, but they do not repair fibrosis or reverse structural changes in the vulvar tissue.
The starting hypothesis of the research program was that adipose-derived mesenchymal stem cells—with documented anti-inflammatory and immunomodulatory properties in other pathologies—could act on the underlying mechanisms of VLS differently than corticosteroids: by modulating the autoimmune response and stimulating tissue regeneration.
The research program was designed to subject this hypothesis to rigorous clinical evaluation, evolving through its various phases until defining the current protocol based on nanofat and stromal vascular fraction (SVF).
Trial methodology
Study type: Prospective single-arm pilot study, conducted at the La Fe University Hospital in Valencia, with the support of the La Fe Health Research Institute (IIS La Fe).
Identifier: NCT03961126 (ClinicalTrials.gov)
Period: 2017-2020
Inclusion criteria:
> Adult women with a confirmed diagnosis of vulvar lichen sclerosus
> With moderate-to-severe disease involvement
> With insufficient response to conventional corticosteroid treatment
Evaluation variables:
> Symptoms: itching, burning, dyspareunia—measured using validated scales at each visit
> Clinical signs: protocolized examination and photographic documentation
> Histology: comparative vulvar biopsy before the procedure and at 3 months
> Quality of life: validated pre- and post-procedure questionnaires
> Safety: recording of adverse effects throughout the follow-up period
**Follow-up:** 12 months per patient
What the trial demonstrated
The results of the research program, published in *Aesthetic Plastic Surgery* (2022) and subsequently expanded in *Aesthetic Surgery Journal* (2025), showed:
> Significant symptomatic improvement. Patients treated with the Liquenia-SVF protocol experienced a statistically significant reduction in vulvar itching, burning, and dyspareunia, as assessed by validated scales during the 12-month follow-up.
> Favorable histological changes. Comparison of biopsies before and after the procedure documented changes at the tissue level: reduction of fibrosis, increase in epithelial thickness, and improvement in vascularization—changes that corticosteroids alone do not produce.
> Excellent safety profile. No serious complications were recorded during the follow-up period. The procedure proved to be safe, with the expected adverse effects of any minor surgical procedure under local anesthesia.
> Maintenance of results. The observed improvements were maintained during the 12-month follow-up, without the need for additional sessions in most cases.
Aesthetic Surgery Journal 2025 Study
Honest interpretation of data
Scientific honesty requires presenting results within their methodological context. The Liquenia-SVF trial is a pilot study with a limited sample size—consistent with its role as a feasibility and safety study prior to larger-scale studies. The results are promising and have been reproduced in subsequent clinical practice, but they must be interpreted in that context.
The inclusion of the protocol in the 2025 ISAPS Clinical Practice Guideline represents an independent evaluation of this evidence by an international scientific committee—an external validation that complements the trial data.
Larger-scale studies with control groups are the logical next step in the development of evidence. Research continues.