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

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ClinicalTrials.gov Identifier: NCT05464290
Recruitment Status : Recruiting
First Posted : July 19, 2022
Last Update Posted : July 19, 2022
University of Pisa
Universita di Verona
Information provided by (Responsible Party):
Antonio Luigi Pastore, University of Roma La Sapienza

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Urethral Stricture Procedure: NANOfat grafting Not Applicable

Detailed Description:

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'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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nonfat Grafting in Male and Female Genital Lichen Sclerosus
Estimated Study Start Date : July 25, 2022
Estimated Primary Completion Date : November 20, 2022
Estimated Study Completion Date : January 25, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nanofat grafting
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
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.

Primary Outcome Measures :
  1. SURGICAL OUTCOMES [ Time Frame: 90 days after nonfat grafting ]
    Visual Analog Score for pain

  2. SURGICAL OUTCOMES [ Time Frame: 180 days after nonfat grafting ]
    Visual Analog Score for pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • patients over 18 years of age, affected by genital lichen sclerosus

Exclusion Criteria:

  • patients with age <18 y.o.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05464290

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Antonio Luigi Pastore Recruiting
Latina, Italy, 04100
Contact: Antonio Luigi Pastore, Prof    3401138648 ext 0039    antopast@hotmail.com   
Sponsors and Collaborators
University of Roma La Sapienza
University of Pisa
Universita di Verona
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Principal Investigator: Antonio Luigi Pastore, Prof Sapienza University of Rome
Publications of Results:
Other Publications:
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Responsible Party: Antonio Luigi Pastore, Prof, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT05464290    
Other Study ID Numbers: Lichen AND Nanofat grafting
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urethral Stricture
Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Urethral Obstruction
Urethral Diseases
Urologic Diseases