MedTrace Logo

Nanofat Grafting in Male and Female Subjects Affected by Urethral Strictures

NCT05451732 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-07-14

No results posted yet for this study

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.

Conditions

  • Urethral Stricture

Interventions

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.

Sponsors & Collaborators

  • University of Pisa

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-12-15
Completion
2023-01-01

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05451732 on ClinicalTrials.gov