Nanofat Grafting in Male and Female Subjects Affected by Urethral Strictures (NFUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05451732|
Recruitment Status : Recruiting
First Posted : July 11, 2022
Last Update Posted : July 14, 2022
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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)
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
|Contact: Antonio Luigi Pastore, Proffirstname.lastname@example.org|
|Antonio Luigi Pastore||Recruiting|
|Latina, Italy, 04100|
|Contact: Antonio Luigi Pastore, Prof 3401138648 email@example.com|