Urethral StrictureNFUSNCT05451732
Nanofat Grafting in Male and Female Subjects Affected by Urethral Strictures
A study testing Nanofat grafting in people with Urethral Stricture, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
In 2001 Zuk 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 1 Jan 2022to 1 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urethral stricture naive or recurrent in male and female patients aged > 18 y.o.
Who cannot join
- Neurogenic urinary tract disorders
- Urinary tract infections
- 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, antopast@hotmail.com
About this study
Official title: New Autologous Fat Graft for the Treatment of Urethral Stricture
In 2001 Zuk 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 makes 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 remodeling.
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 more
Nanofat represents a particular formulation of adipose grafting because it is liquid and it is easily transferable to tissues by injection. The nanofat because is free of whole adipocytes does not have the side effects of others adipose-derived formulations containing whole adipocytes (microfat, lipofilling, macrofat), such as the formation of deposits, granulomas, oily cysts, keloids.
Investigators aim to evaluate the use of nanofat grafting in the treatment in urethral strictures of the female and male urethras.
Read the detailed description
Urethral stricture is the reduction of the urethral lumen due to the growth of scar tissue inside the urethral wall, due to various causes.
In the last thirty years, in reconstructive urethral surgery have been described several urethroplasties to repair the urethra and to restore urinary flow.
Obstructed stricture were treated with the removal of the urethral tract stricture and with the anastomosis of the two urethral stumps by the technique called "end-to end anastomosis". This technique is today reserved only for cases of complete urethral stricture of the male urethra because it causes many negative consequences on the sexual activity: shortening of the urethra and the penis, abnormal curvature of the penis in erection, reduction of penile sensitivity. In female urethral stricture this technique has never been used.
Many urethroplasties have been described with the enlargement of the urethra with a good success rate, but some risks such as the formation of fistulas and redo of the stricture. Today several autologous graft tissues are used including the genital and extragenital skin and the buccal mucosa. The use of preputial skin requires complete circumcision and is often not accepted by the patient. The use of extragenital skin is invasive and is used in some long male urethral stricture, while it is not used in female urethral reconstruction.
The buccal mucosa is today considered the optimal graft tissue, due to its histological characteristics that make it suitable for the reparative urethral surgery. However, it must be considered that the withdrawal can be a potential cause of oral complications and, moreover, there is a limit to the length of the tissue that can be taken and is a medium invasive procedure, with discomfort of the patient in the days following the harvest.
Over the last decade, many tissue engineering have been carried out in an attempt to create a tissue that could have the appropriate histological characteristics and size, but without the risk of complications related to the harvest. Many studies have concluded that tissue engineering is not usable except in specialized laboratories, because of its high costs and because not given satisfactory results.
Since 2001, the new concept of "tissue regeneration" has been born through plastic surgery techniques that involve the use of ultra-purified adipose tissue graft rich in stem cells and growth factors that regenerate scar tissues, as the urethral stricture.
In 2001 Zuk 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 makes 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 remodeling.
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.
Nanofat represents a particular formulation of adipose grafting because it is liquid and it is easily transferable to tissues by injection. The nanofat because is free of whole adipocytes does not have the side effects of others adipose-derived formulations containing whole adipocytes (microfat, lipofilling, macrofat), such as the formation of deposits, granulomas, oily cysts, keloids.
We aim to investigate the use of nanofat grafting in the treatment in urethral strictures of the female and male urethras.
Broad-spectrum antibiotic prophylaxis amoxicillin + clavulanic acid is carried out one hour before anesthesia.
After infiltration procedure with Klein's solution in the donor area, the lipoaspirate was obtained by means of a small 3 mm multiport collection cannula with 1 mm diameter side holes. The collection cannula was connected to a 60 ml syringe and the syringe plunger was pulled back to create an adequate negative pressure. The adipose tissue was decanted. At the end of liposuction, the contour deformities of the donor area were prevented by using a smaller diameter cannula, avoiding aspirations from the superficial layers, employing a "crossing" technique and allowing a slight under correction.
To obtain the nanofat, according to Tonnard's technique, the emulsification was obtained by moving the fat between two 10 cc syringes connected by a 1.4 mm connector. The same procedure is repeated with a 1.2 mm connector. This progressive emulsification process is important to ensure the destruction of all adipocytes. The product is then passed through a 400- or 600-micron filter to remove the connective tissue. In this way the liposuction become into nanofat. The nanofat in a 10-cc syringe connected with a 25 gauge needle is then used to create tunnels in the plane of the sclerotic tissues and the nanofat is introduced into the tunnels. Unlike other autologous grafts (skin and mucous membranes) the adipose tissue is transferred by injection and in this way access to urethral stricture is carried out with a minimal incision of the male urethra while in the female urethra is transferred exclusively with injections, without incision of urethral or genital tissue.
A catheter is left in place for 3 weeks.
- 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
Naofat grafting in the urethral stricture. The autologous adipose tissue is transferred by injection and in this way, the access to the urethral stricture is carried out with a minimal incision of the male urethra while in the female urethra is transferred exclusively with injections, without incision of urethral tissue.
| Study group | Role | What they receive |
|---|---|---|
| Nanofat grafting | Experimental | Nanofat grafting with tissue transfer by injection in the urethral stricture Receives: Procedure: Nanofat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
uroflow time 1
Uroflowmetry examination (ml/sec)
Measured: 90 days after nonfat grafting
uroflow time 2
Uroflowmetry examination (ml/sec)
Measured: 180 days after nonfat grafting
Functional time 1
Post ovoidal residue (ML)
Measured: 90 days after nonfat grafting
Functional time 2
Post ovoidal residue (ML)
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 posted11 Jul 2022
- Study start1 Jan 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Responsible party
- Principal investigator, Antonio Luigi Pastore, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451732
- Sponsor's protocol ID
- Urethral Strict and Naofat
- Acronym
- NFUS
- Status last verified
- Jul 2022
- First submitted
- 4 Apr 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be shared with other researchers
Publications
Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
PubMed 23783059
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Autologous Fat Graft for the Treatment of Urethral Stricture
- ClinicalTrials.gov ID
- NCT05451732
- Acronym / sponsor ID
- NFUS / Urethral Strict and Naofat
- 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
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 11 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.
In 2001 Zuk 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 makes 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 remodeling.
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.
Nanofat represents a particular formulation of adipose grafting because it is liquid and it is easily transferable to tissues by injection. The nanofat because is free of whole adipocytes does not have the side effects of others adipose-derived formulations containing whole adipocytes (microfat, lipofilling, macrofat), such as the formation of deposits, granulomas, oily cysts, keloids.
Investigators aim to evaluate the use of nanofat grafting in the treatment in urethral strictures of the female and male urethras.
Detailed description
Urethral stricture is the reduction of the urethral lumen due to the growth of scar tissue inside the urethral wall, due to various causes.
In the last thirty years, in reconstructive urethral surgery have been described several urethroplasties to repair the urethra and to restore urinary flow.
Obstructed stricture were treated with the removal of the urethral tract stricture and with the anastomosis of the two urethral stumps by the technique called "end-to end anastomosis". This technique is today reserved only for cases of complete urethral stricture of the male urethra because it causes many negative consequences on the sexual activity: shortening of the urethra and the penis, abnormal curvature of the penis in erection, reduction of penile sensitivity. In female urethral stricture this technique has never been used.
Many urethroplasties have been described with the enlargement of the urethra with a good success rate, but some risks such as the formation of fistulas and redo of the stricture. Today several autologous graft tissues are used including the genital and extragenital skin and the buccal mucosa. The use of preputial skin requires complete circumcision and is often not accepted by the patient. The use of extragenital skin is invasive and is used in some long male urethral stricture, while it is not used in female urethral reconstruction.
The buccal mucosa is today considered the optimal graft tissue, due to its histological characteristics that make it suitable for the reparative urethral surgery. However, it must be considered that the withdrawal can be a potential cause of oral complications and, moreover, there is a limit to the length of the tissue that can be taken and is a medium invasive procedure, with discomfort of the patient in the days following the harvest.
Over the last decade, many tissue engineering have been carried out in an attempt to create a tissue that could have the appropriate histological characteristics and size, but without the risk of complications related to the harvest. Many studies have concluded that tissue engineering is not usable except in specialized laboratories, because of its high costs and because not given satisfactory results.
Since 2001, the new concept of "tissue regeneration" has been born through plastic surgery techniques that involve the use of ultra-purified adipose tissue graft rich in stem cells and growth factors that regenerate scar tissues, as the urethral stricture.
In 2001 Zuk 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 makes 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 remodeling.
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.
Nanofat represents a particular formulation of adipose grafting because it is liquid and it is easily transferable to tissues by injection. The nanofat because is free of whole adipocytes does not have the side effects of others adipose-derived formulations containing whole adipocytes (microfat, lipofilling, macrofat), such as the formation of deposits, granulomas, oily cysts, keloids.
We aim to investigate the use of nanofat grafting in the treatment in urethral strictures of the female and male urethras.
Broad-spectrum antibiotic prophylaxis amoxicillin + clavulanic acid is carried out one hour before anesthesia.
After infiltration procedure with Klein's solution in the donor area, the lipoaspirate was obtained by means of a small 3 mm multiport collection cannula with 1 mm diameter side holes. The collection cannula was connected to a 60 ml syringe and the syringe plunger was pulled back to create an adequate negative pressure. The adipose tissue was decanted. At the end of liposuction, the contour deformities of the donor area were prevented by using a smaller diameter cannula, avoiding aspirations from the superficial layers, employing a "crossing" technique and allowing a slight under correction.
To obtain the nanofat, according to Tonnard's technique, the emulsification was obtained by moving the fat between two 10 cc syringes connected by a 1.4 mm connector. The same procedure is repeated with a 1.2 mm connector. This progressive emulsification process is important to ensure the destruction of all adipocytes. The product is then passed through a 400- or 600-micron filter to remove the connective tissue. In this way the liposuction become into nanofat. The nanofat in a 10-cc syringe connected with a 25 gauge needle is then used to create tunnels in the plane of the sclerotic tissues and the nanofat is introduced into the tunnels. Unlike other autologous grafts (skin and mucous membranes) the adipose tissue is transferred by injection and in this way access to urethral stricture is carried out with a minimal incision of the male urethra while in the female urethra is transferred exclusively with injections, without incision of urethral or genital tissue.
A catheter is left in place for 3 weeks.
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 graftingNanofat grafting with tissue transfer by injection in the urethral stricture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Urethral stricture naive or recurrent in male and female patients aged > 18 y.o.
Key exclusion criteria (3 listed)
- Neurogenic urinary tract disorders
- Urinary tract infections
- 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 graftingNaofat grafting in the urethral stricture. The autologous adipose tissue is transferred by injection and in this way, the access to the urethral stricture is carried out with a minimal incision of the male urethra while in the female urethra is transferred exclusively with injections, without incision of urethral tissue. | Procedure or surgery | Nanofat grafting |
Primary outcome
uroflow time 1
Time frame: 90 days after nonfat grafting
Uroflowmetry examination (ml/sec)
uroflow time 2
Time frame: 180 days after nonfat grafting
Uroflowmetry examination (ml/sec)
Functional time 1
Time frame: 90 days after nonfat grafting
Post ovoidal residue (ML)
Functional time 2
Time frame: 180 days after nonfat grafting
Post ovoidal residue (ML)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Background: PubMed 23783059Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
- Individual participant dataSharing planned: Yes. All IPD will be shared with other researchers
Related trials for Urethral Stricture
RecruitingObservational study
Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
Genitourinary Anatomy
RecruitingObservational study
Urethral Resistive Index (URI): A New Parameter for Diagnosing Urethral Obstruction
Urethral Stricture
Recruiting
Intraoperative Lidocaine or Dexmedetomidine for Postoperative Pain Modulation After Urethral Reconstruction.
Urethral Stricture
Active, not recruiting
Outcomes of Double-face Augmentation Urethroplasty
Urethral Stricture, Anterior, Urethral Stricture Disease
Active, not recruitingPhase 4
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Urethral Stricture
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.
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 3 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 14 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?
Contact Antonio Luigi Pastore, Prof (00393401138648, antopast@homail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uroflow time 1 (time frame: 90 days after nonfat grafting). The study lists 4 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 NCT05451732, which also lists 1 linked publication.
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 14 Jul 2022.