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Nanofat Grafting in Male and Female Subjects Affected by Urethral Strictures (NFUS)

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ClinicalTrials.gov Identifier: NCT05451732
Recruitment Status : Recruiting
First Posted : July 11, 2022
Last Update Posted : July 14, 2022
Sponsor:
Collaborator:
University of Pisa
Information provided by (Responsible Party):
Antonio Luigi Pastore, University of Roma La Sapienza

Brief 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. 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.


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

Show Show detailed description

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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: New Autologous Fat Graft for the Treatment of Urethral Stricture
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : January 1, 2023

Arm Intervention/treatment
Experimental: Nanofat grafting
Nanofat grafting with tissue transfer by injection in the urethral stricture
Procedure: Nanofat grafting
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.




Primary Outcome Measures :
  1. uroflow time 1 [ Time Frame: 90 days after nonfat grafting ]
    Uroflowmetry examination (ml/sec)

  2. uroflow time 2 [ Time Frame: 180 days after nonfat grafting ]
    Uroflowmetry examination (ml/sec)

  3. Functional time 1 [ Time Frame: 90 days after nonfat grafting ]
    Post ovoidal residue (ML)

  4. Functional time 2 [ Time Frame: 180 days after nonfat grafting ]
    Post ovoidal residue (ML)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urethral stricture naive or recurrent in male and female patients aged > 18 y.o.

Exclusion Criteria:

  • Neurogenic urinary tract disorders
  • Urinary tract infections
  • 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): NCT05451732


Contacts
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Contact: Antonio Luigi Pastore, Prof 00393401138648 antopast@homail.com

Locations
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Italy
Antonio Luigi Pastore Recruiting
Latina, Italy, 04100
Contact: Antonio Luigi Pastore, Prof    3401138648    antopast@hotmail.com   
Sponsors and Collaborators
University of Roma La Sapienza
University of Pisa
Publications:
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Responsible Party: Antonio Luigi Pastore, Associate Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT05451732    
Other Study ID Numbers: Urethral Strict and Naofat
First Posted: July 11, 2022    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD will be shared with other researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Every 4 weeks
Access Criteria: by mail

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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
Constriction, Pathologic
Pathological Conditions, Anatomical
Urethral Obstruction
Urethral Diseases
Urologic Diseases