Urethral StrictureLSNanofatNCT05464290
The Nanofat Regenerative Surgery for Management of Genital Lichen Sclerosus in Male and Female Patients
A study testing NANOfat grafting in people with Urethral Stricture, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- NANOfat grafting
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jul 2022to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients over 18 years of age, affected by genital lichen sclerosus
Who cannot join
- patients with age <18 y.o.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Antonio Luigi Pastore
Latina, 04100
Antonio Luigi Pastore, Prof, 3401138648 ext. 0039, antopast@hotmail.com
About this study
Official title: Nonfat Grafting in Male and Female Genital Lichen Sclerosus
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.
Read the 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.
- Conditions
- Urethral Stricture
- Being tested
- NANOfat grafting
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NANOfat graftingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Nanofat grafting | Experimental | 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. Receives: Procedure: NANOfat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
SURGICAL OUTCOMES
Visual Analog Score for pain
Measured: 90 days after nonfat grafting
SURGICAL OUTCOMES
Visual Analog Score for pain
Measured: 180 days after nonfat grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start25 Jul 2022 (estimated)
- Primary completion20 Nov 2022 (estimated)
- Study completion25 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pisa, Universita di Verona
- Responsible party
- Principal investigator, Antonio Luigi Pastore, University of Roma La Sapienza
- Investigators
- Antonio Luigi Pastore, Prof, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464290
- Sponsor's protocol ID
- Lichen AND Nanofat grafting
- Acronym
- LSNanofat
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26710034Doornaert 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.
PubMed 30622707
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonfat Grafting in Male and Female Genital Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT05464290
- Acronym / sponsor ID
- LSNanofat / Lichen AND Nanofat grafting
- Conditions
- Urethral Stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- University of Pisa, Universita di Verona
- Study start
- 25 Jul 2022 (estimated)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 25 Jan 2023 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nanofat grafting | Experimental | Procedure: NANOfat graftingThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients over 18 years of age, affected by genital lichen sclerosus
Key exclusion criteria (1 listed)
- patients with age <18 y.o.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NANOfat graftingThe 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. | Procedure or surgery | Nanofat grafting |
Primary outcome
SURGICAL OUTCOMES
Time frame: 90 days after nonfat grafting
Visual Analog Score for pain
SURGICAL OUTCOMES
Time frame: 180 days after nonfat grafting
Visual Analog Score for pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Background: PubMed 26710034Conde-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 publication: PubMed 30622707Doornaert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Luigi Pastore, Prof principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NANOfat grafting in people with Urethral Stricture, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SURGICAL OUTCOMES (time frame: 90 days after nonfat grafting). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05464290, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.