The Nanofat Regenerative Surgery for Management of Genital Lichen Sclerosus in Male and Female Patients (LSNanofat)
Primary Purpose
Urethral Stricture
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
NANOfat grafting
Sponsored by
About this trial
This is an interventional treatment trial for Urethral Stricture
Eligibility Criteria
Inclusion Criteria:
- patients over 18 years of age, affected by genital lichen sclerosus
Exclusion Criteria:
- patients with age <18 y.o.
Sites / Locations
- Antonio Luigi PastoreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nanofat grafting
Arm Description
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.
Outcomes
Primary Outcome Measures
SURGICAL OUTCOMES
Visual Analog Score for pain
SURGICAL OUTCOMES
Visual Analog Score for pain
Secondary Outcome Measures
Full Information
NCT ID
NCT05464290
First Posted
July 5, 2022
Last Updated
July 14, 2022
Sponsor
University of Roma La Sapienza
Collaborators
University of Pisa, Universita di Verona
1. Study Identification
Unique Protocol Identification Number
NCT05464290
Brief Title
The Nanofat Regenerative Surgery for Management of Genital Lichen Sclerosus in Male and Female Patients
Acronym
LSNanofat
Official Title
Nonfat Grafting in Male and Female Genital Lichen Sclerosus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Anticipated)
Primary Completion Date
November 20, 2022 (Anticipated)
Study Completion Date
January 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
Collaborators
University of Pisa, Universita di Verona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nanofat grafting
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
NANOfat grafting
Intervention Description
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 Measure Information:
Title
SURGICAL OUTCOMES
Description
Visual Analog Score for pain
Time Frame
90 days after nonfat grafting
Title
SURGICAL OUTCOMES
Description
Visual Analog Score for pain
Time Frame
180 days after nonfat grafting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients over 18 years of age, affected by genital lichen sclerosus
Exclusion Criteria:
patients with age <18 y.o.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Luigi Pastore, Prof
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antonio Luigi Pastore
City
Latina
ZIP/Postal Code
04100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Luigi Pastore, Prof
Phone
3401138648
Ext
0039
Email
antopast@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26710034
Citation
Conde-Green A, Marano AA, Lee ES, Reisler T, Price LA, Milner SM, Granick MS. Fat Grafting and Adipose-Derived Regenerative Cells in Burn Wound Healing and Scarring: A Systematic Review of the Literature. Plast Reconstr Surg. 2016 Jan;137(1):302-312. doi: 10.1097/PRS.0000000000001918.
Results Reference
background
PubMed Identifier
30622707
Citation
Doornaert M, Colle J, De Maere E, Declercq H, Blondeel P. Autologous fat grafting: Latest insights. Ann Med Surg (Lond). 2018 Oct 16;37:47-53. doi: 10.1016/j.amsu.2018.10.016. eCollection 2019 Jan.
Results Reference
result
Learn more about this trial
The Nanofat Regenerative Surgery for Management of Genital Lichen Sclerosus in Male and Female Patients
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