NCT05451732

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

April 4, 2022

Last Update Submit

July 11, 2022

Conditions

Urethral Stricture

Outcome Measures

Primary Outcomes (4)

  • uroflow time 1

    Uroflowmetry examination (ml/sec)

    90 days after nonfat grafting

  • uroflow time 2

    Uroflowmetry examination (ml/sec)

    180 days after nonfat grafting

  • Functional time 1

    Post ovoidal residue (ML)

    90 days after nonfat grafting

  • Functional time 2

    Post ovoidal residue (ML)

    180 days after nonfat grafting

Study Arms (1)

Nanofat grafting

EXPERIMENTAL

Nanofat grafting with tissue transfer by injection in the urethral stricture

Procedure: Nanofat grafting

Interventions

Nanofat graftingPROCEDURE

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.

Nanofat grafting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Neurogenic urinary tract disorders
  • Urinary tract infections
  • Age \< 18 y.o.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonio Luigi Pastore

Latina, 04100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23783059BACKGROUND

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Antonio Luigi Pastore, Prof

CONTACT

00393401138648antopast@homail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 4, 2022

First Posted

July 11, 2022

Study Start

January 1, 2022

Primary Completion

December 15, 2022

Study Completion

January 1, 2023

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

All IPD will be shared with other researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Every 4 weeks
Access Criteria
by mail

Locations

IT(1)