NCT05464290

Brief Summary

Regenerative surgery is an emerging multidisciplinary field actually based on derived adipose tissue. Autologous fat grafting was first described by Neuber in 1893 and since then it has developed over the next century. The initial goal of fat grafting was to treat volume losses created by disease or trauma. Further studies done by Zuk et al. in 2001 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 make 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 remodelling. 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.

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 Jul 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 5, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

July 5, 2022

Last Update Submit

July 14, 2022

Conditions

Urethral Stricture

Outcome Measures

Primary Outcomes (2)

  • SURGICAL OUTCOMES

    Visual Analog Score for pain

    90 days after nonfat grafting

  • SURGICAL OUTCOMES

    Visual Analog Score for pain

    180 days after nonfat grafting

Study Arms (1)

Nanofat grafting

EXPERIMENTAL

The nanofat in a 10 cc syringe connected with a 23 gauge needle is used to create a lot of tunnels in the plane of the sclerotic tissues and the nanofat is delivered into the tunnels.

Procedure: NANOfat grafting

Interventions

NANOfat graftingPROCEDURE

The nanofat in a 10 cc syringe connected with a 23 gauge needle is then used to create a lot of tunnels in the plane of the sclerotic tissues and the nanofat is delivered into the tunnels. During injection the area is massaged to achieve complete releasing of fibrous tissue that was feel under the fingers.

Nanofat grafting

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients over 18 years of age, affected by genital lichen sclerosus

You may not qualify if:

  • patients with 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 (2)

  • Conde-Green A, Marano AA, Lee ES, Reisler T, Price LA, Milner SM, Granick MS. Fat Grafting and Adipose-Derived Regenerative Cells in Burn Wound Healing and Scarring: A Systematic Review of the Literature. Plast Reconstr Surg. 2016 Jan;137(1):302-312. doi: 10.1097/PRS.0000000000001918.

    PMID: 26710034BACKGROUND

  • Doornaert M, Colle J, De Maere E, Declercq H, Blondeel P. Autologous fat grafting: Latest insights. Ann Med Surg (Lond). 2018 Oct 16;37:47-53. doi: 10.1016/j.amsu.2018.10.016. eCollection 2019 Jan.

    PMID: 30622707RESULT

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

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

Study Officials

  • Antonio Luigi Pastore, Prof

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

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
Prof

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 19, 2022

Study Start

July 25, 2022

Primary Completion

November 20, 2022

Study Completion

January 25, 2023

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)