NCT03913910

Brief Summary

The study aims to evaluate the efficacy of the local injection of autologous micro-fragmented adipose tissue obtained with the Lipogems®system in patients with trans-sphincteric fistulas untreatable with fistulotomy.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

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

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

11 months

First QC Date

April 11, 2019

Last Update Submit

May 10, 2019

Conditions

Perianal Fistula

Keywords

Autologous micro-fragmented adipose tissuePerianal fistulaLipogemsMesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

  • Healing

    Closing of the fistula tract (internal and external orifice)

    12 months

Secondary Outcomes (5)

  • Safety collecting all types of adverse events

    12 months

  • Pain assessed using the Visual Analogue Scale (VAS) for pain

    12 months

  • Continence

    12 months

  • Patient's satisfaction

    12 months

  • Non inferiority compared with the Advancement flap technique

    12 months

Study Arms (1)

Lipogems

Lipogems injection in the internal orifice, mucosal, submucosal and muscular layer, in the fistula tract and external orifice.

Procedure: Lipogems

Interventions

LipogemsPROCEDURE

Autologous micro-fragmented adipose tissue is injected in the internal orifice, mucosal, submucosal and muscular layer, then in the fistula tract and external orifice in addition to anal flap.

Lipogems

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a diagnosis of transphincteric anal fistula that is not suitable to be laid open.

You may qualify if:

  • Patients of both sexes, aged over 18 and under 80 years old.
  • Diagnosis, confirmed by standard methods (magnetic resonance and/or trans anal ultrasound), of complex fistula (trans-sphincteric unsuitable for treatment lay-open) without any secondary tracts and no active septic processes, performed 2-4 weeks after the first perianal access drainage procedure and fistulectomy, with positioning of a drainage seton.
  • Seton placed at least 4-6 weeks previously
  • No previous sphincter saving procedures for the anal fistula
  • No limitations to a periodic follow-up lasting for a total of 12 months
  • Informed consent form signed

You may not qualify if:

  • Patients with multiple fistulas
  • Active septic process
  • Patients unable to follow the pathway required by the protocol
  • Patients with active Human Immunodeficiency Virus, Hepatitis B Virus or Hepatitis C Virus infections
  • Patients with Irritable Bowel Syndrome
  • Patients with rectal-vaginal fistulas
  • Patients with a history of cancer lasting less than 5 years
  • Patients undergoing cortisone and/or immunosuppressive and/or anticoagulant therapy
  • Patients with a history rectal or pelvic radiotherapy
  • Pregnant women
  • Patients with connective tissue diseases and/or coagulation diseases and/or uncompensated diabetes mellitus
  • Failure to sign the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Pisana - Cisanello

Pisa, Tuscany, 56124, Italy

RECRUITING

Related Publications (9)

  • Naldini G, Sturiale A, Fabiani B, Giani I, Menconi C. Micro-fragmented adipose tissue injection for the treatment of complex anal fistula: a pilot study accessing safety and feasibility. Tech Coloproctol. 2018 Feb;22(2):107-113. doi: 10.1007/s10151-018-1755-8. Epub 2018 Feb 16.

    PMID: 29453515BACKGROUND

  • Tremolada C, Colombo V, Ventura C. Adipose Tissue and Mesenchymal Stem Cells: State of the Art and Lipogems(R) Technology Development. Curr Stem Cell Rep. 2016;2(3):304-312. doi: 10.1007/s40778-016-0053-5. Epub 2016 Jul 13.

    PMID: 27547712BACKGROUND

  • Ceserani V, Ferri A, Berenzi A, Benetti A, Ciusani E, Pascucci L, Bazzucchi C, Cocce V, Bonomi A, Pessina A, Ghezzi E, Zeira O, Ceccarelli P, Versari S, Tremolada C, Alessandri G. Angiogenic and anti-inflammatory properties of micro-fragmented fat tissue and its derived mesenchymal stromal cells. Vasc Cell. 2016 Aug 18;8:3. doi: 10.1186/s13221-016-0037-3. eCollection 2016.

    PMID: 27547374BACKGROUND

  • Tremolada C, Ricordi C, Caplan AI, Ventura C. Mesenchymal Stem Cells in Lipogems, a Reverse Story: from Clinical Practice to Basic Science. Methods Mol Biol. 2016;1416:109-22. doi: 10.1007/978-1-4939-3584-0_6.

    PMID: 27236668BACKGROUND

  • Vezzani B, Shaw I, Lesme H, Yong L, Khan N, Tremolada C, Peault B. Higher Pericyte Content and Secretory Activity of Microfragmented Human Adipose Tissue Compared to Enzymatically Derived Stromal Vascular Fraction. Stem Cells Transl Med. 2018 Dec;7(12):876-886. doi: 10.1002/sctm.18-0051. Epub 2018 Sep 26.

    PMID: 30255987BACKGROUND

  • Garcia-Contreras M, Messaggio F, Mendez AJ, Ricordi C. Metabolomic changes in human adipose tissue derived products following non-enzymatic microfacturing. Eur Rev Med Pharmacol Sci. 2018 May;22(10):3249-3260. doi: 10.26355/eurrev_201805_15088.

    PMID: 29863273BACKGROUND

  • Cestaro G, De Rosa M, Massa S, Amato B, Gentile M. Intersphincteric anal lipofilling with micro-fragmented fat tissue for the treatment of faecal incontinence: preliminary results of three patients. Wideochir Inne Tech Maloinwazyjne. 2015 Jul;10(2):337-41. doi: 10.5114/wiitm.2014.47435. Epub 2014 Dec 4.

    PMID: 26240640BACKGROUND

  • Bianchi F, Maioli M, Leonardi E, Olivi E, Pasquinelli G, Valente S, Mendez AJ, Ricordi C, Raffaini M, Tremolada C, Ventura C. A new nonenzymatic method and device to obtain a fat tissue derivative highly enriched in pericyte-like elements by mild mechanical forces from human lipoaspirates. Cell Transplant. 2013;22(11):2063-77. doi: 10.3727/096368912X657855. Epub 2012 Oct 8.

    PMID: 23051701BACKGROUND

  • Paolella F, Manferdini C, Gabusi E, Gambari L, Filardo G, Kon E, Mariani E, Lisignoli G. Effect of microfragmented adipose tissue on osteoarthritic synovial macrophage factors. J Cell Physiol. 2019 Apr;234(4):5044-5055. doi: 10.1002/jcp.27307. Epub 2018 Sep 6.

    PMID: 30187478BACKGROUND

Central Study Contacts

Gabriele Naldini, MD

CONTACT

+39050997802gabrielenaldini65@gmail.com

Alessandro Sturiale, MD

CONTACT

+39050997814alexstur@yahoo.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 12, 2019

Study Start

February 1, 2019

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

May 14, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)