The Nanofat Regenerative Surgery for Management of Genital Lichen Sclerosus in Male and Female Patients

Study Overview
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Brief Summary
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Regenerative surgery is an emerging multidisciplinary field actually based on derived adipose tissue. Autologous fat grafting was first described by Neuber in 1893 and since then it has developed over the next century. The initial goal of fat grafting was to treat volume losses created by disease or trauma. Further studies done by Zuk et al. in 2001 showed that lipoaspirate contains multipotent adipose stem cells (ADSCs) like in the bone marrow, thereby expanding opportunities in multiple fields. ADSCs have emerged as a key element of regenerative medicine surgery due to their ability to differentiate into a variety of different cell lineages. Moreover, their capacity of paracrine secretion of a broad selection of cytokines, chemokines, and growth factors make them highly clinically attractive. More specific, of particular interest are the anti-apoptotic, anti-inflammatory, proangiogenic, immunomodulatory, and anti-scarring effects that have been demonstrated for ADSCs, which effects on wound healing, soft-tissue restoration and scar remodelling. Nanofat firstly introduced by Tonnard in 2013, is an ultra-purified adipose tissue-derived product that is devoid of mature adipocytes but rich in ADSCs and with regenerative properties.

Detailed Description
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Lichen sclerosus is a chronic, inflammatory, mucocutaneous disorder of genital and extragenital skin. It was first described by Hallopeau in 1881. In 1976, the International Society for the Study of Vulvovaginal Disease concluded that the terminology LS should be adopted for men and women. Both sexes are affected, but it is 6 to 10 times more prevalent in women than in men. LS can occur at any age, but the incidence increases with age. The aetiology of LS remains unknown thought infectious, autoimmune, and chronic irritation was investigated for the develop of LS. The autoimmune pathogenesis seems most likely. An increased incidence of autoantibodies to the extracellular matrix protein and autoantibodies to BP180 antigen in LS are reported .Other potential markers include CD4+ T-cells clones, which are found in overabundance in LS patients&#39;s tissue. and possibly promote fibroblast cell proliferation. Risk factor to progression of LS was occlusion and exposure of urine. The susceptible epithelium may play a central role in the pathogenesis of LS. The skin may have an isotraumatopic response, to urine, feces, and other non-specific liquid irritants in occluded spaces and may play an important role in the etiology of LS in both men and women. The Köbner phenomenon describes the occurrence of disease- specific lesions on normal appearing skin after trauma and it is described in LS. Mechanical factors like friction due to tight clothing, occlusion, surgical trauma, radiotherapy and scars are thought to play an important role in triggering and maintaining LS . Some patients with lichen sclerosus do not have any symptoms, while most patients experience intense itching, discomfort and/or erosions/ulcers. LS is a debilitating disease, causing itch, pain, dysuria and restriction of micturition, dyspareunia, and significant sexual dysfunction in women and men. Vulvar itching, bleeding, or pain, pain during sex, skin bruising and tearing , blisters, easy bleeding from minor rubbing of the skin, trouble urinating or pain with urination, painful erections (in men). Lichen sclerosus typically has a remitting relapsing course that is complicated by permanent scarring of the affected areas. Biopsy is worthwhile both to confirm the diagnosis and to exclude malignant change. It has been suggested that the expression of selected cellular markers (such as p53, survivin, telomerase, Ki-67, and cyclin D1) can help distinguish between indolent LS and LS with true malignant potential. Topical and systemic treatments have been addressed but with few results. Surgery represent the solution for genital and urethral involvement. Depending on extension of genital and urethral involvement, surgical repair can range from a minimally invasive treatment to a more extensive reconstruction but still today surgery represents an open debate.

Official Title
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Nonfat Grafting in Male and Female Genital Lichen Sclerosus

Conditions
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Urethral Stricture

Intervention / Treatment
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* Procedure: NANOfat grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients over 18 years of age, affected by genital lichen sclerosus Exclusion Criteria: patients with age <18 y.o.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nanofat grafting<br>The nanofat in a 10 cc syringe connected with a 23 gauge needle is used to create a lot of tunnels in the plane of the sclerotic tissues and the nanofat is delivered into the tunnels. | Procedure: NANOfat grafting<br>* The nanofat in a 10 cc syringe connected with a 23 gauge needle is then used to create a lot of tunnels in the plane of the sclerotic tissues and the nanofat is delivered into the tunnels. During injection the area is massaged to achieve complete releasing of fibrous tissue that was feel under the fingers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SURGICAL OUTCOMES | Visual Analog Score for pain | 90 days after nonfat grafting | 
| SURGICAL OUTCOMES | Visual Analog Score for pain | 180 days after nonfat grafting |