Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection

NCT04750499 | Unknown

• 1 other identifier: Fistula_CM1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate effectiveness of the association of endorectal advancement flap technique with local injection of autologous and micro-fragmented adipose tissue, obtained with the Lipogems® system, in patients with complex Perianal Fistulas not related to Crohn's Disease.

Conditions

Anal Fistula

Keywords

Complex Anal Fistula; Mesenchymal Stem Cells; Microfragmented adipose tissue; Regenerative Medicine

Outcome Measures

Primary Outcomes (1)

• Healing rate

  Fistula tract closing by clinically assessment and confirmation by pelvic MRI if necessary.

  1 year

Secondary Outcomes (2)

• Incontinence rate

  1 year

• Treatment related adverse events

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Patients with complex anal fistulas, non related to Crohn's disease.

Procedure: Adipose tissue injection associated with endorectal advancement flap.

Interventions

Adipose tissue injection associated with endorectal advancement flap. PROCEDURE

Injection of adipose tissue will be associated with endorectal advancement flap technique. In blind fistulas and special cases, in which the flap is not indicated, alternative techniques will be used. In all cases, autologous, micro-fragmented and minimally manipulated adipose tissue, obtained with a standardized procedure, previously validated and authorized, will be injected. This procedure uses the "Lipogems ®" device (Lipogems International SpA, Milan, Italy), with which a well-characterized adipose tissue is obtained with the maximum safety guarantees.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both genders, aged over 18 years old.
• Diagnosis, confirmed by standard methods (magnetic resonance and/or trans-anal ultrasound), of complex fistula (trans-sphincteric unsuitable for treatment lay-open).
• Seton placed at least 4-6 weeks previously.
• No limitations to a periodic follow-up lasting for a total of 12 months
• Informed consent form signed.

You may not qualify if:

• Active septic process.
• Patients unable to follow the pathway required by the protocol.
• Pregnant women.
• Failure to sign the informed consent form

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic

Barcelona, 08006, Spain

RECRUITING

Related Publications (6)

• 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: 29453515 BACKGROUND

• Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2018 Apr;154(5):1334-1342.e4. doi: 10.1053/j.gastro.2017.12.020. Epub 2017 Dec 24.

  PMID: 29277560 BACKGROUND

• Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a.

  PMID: 22706128 BACKGROUND

• 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: 23051701 BACKGROUND

• 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: 27236668 BACKGROUND

• Guillaumes S, Hidalgo NJ, Bachero I, Pena R, Nogueira ST, Ardid J, Pera M. Efficacy of injection of autologous adipose tissue in the treatment of patients with complex and recurrent fistula-in-ano of cryptoglandular origin. Tech Coloproctol. 2024 Jul 9;28(1):81. doi: 10.1007/s10151-024-02963-x.

  PMID: 38980511 DERIVED

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Salvador Guillaumes, MD PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Nils Jimmy Hidalgo, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Irene Bachero, MD

  Hospital Clinbic. Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salvador Guillaumes, MD PhD

CONTACT

+34 687 795 458; guillaumes@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional (Clinical Trial)

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: September 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)