Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly

The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.

Study Overview

• Status: Recruiting
• Conditions: Anal Fistula
• Intervention / Treatment: Biological: SygeLIX-F + SygeLIX-G

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Laurence BARNOUIN, MD; Phone Number: +33 4 72 68 69 09; Email: laurence.barnouin@tbf-lab.com
• Study Contact Backup: Name: Justine BOSC, MSc; Phone Number: +33 4 72 68 69 11; Email: justine.bosc@tbf-lab.com

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Clinique Blomet
    • Contact: Laurent ABRAMOWITZ, Professor
    • Principal Investigator: Laurent ABRAMOWITZ, Professor
  • Talence, France, 33401
    • Recruiting
    • Maison de Santé Protestante de Bordeaux-Bagatelle
    • Contact: Dominique BOUCHARD, MD
    • Principal Investigator: Dominique BOUCHARD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, aged 18 to 65 years.
• Patient with a single anal fistula resistant after at least one surgical treatment. Fistula may be related to Crohn's disease.
• Patient with an upper transsphincteric or lower transsphincteric fistula.
• Patient presenting fistula with or without intersphincteric diverticula.
• Fistula effectively drained with a seton.
• Informed and consenting patient.
• Patient who is a member or a beneficiary of a national health insurance plan.

Exclusion Criteria:

• Pregnant or breastfeeding woman or woman of childbearing age without effective contraception.
• Patients who have had more than one failed obstruction technique.
• Patient with more than one internal orifice.
• Patient with an MRI proven abscess.
• Patient with an uncontrolled infection.
• Patient with a contraindication to anesthesia.
• Person deprived of liberty by a judicial or administrative decision.
• Adult subjected to a legal protection measure or unable to express his / her consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SygeLIX-F + SygeLIX-G; Combination of SygeLIX-F, a plug made of an assembly of umbilical cord lining and Wharton's jelly in the form of a cylinder of porous structure, and SygeLIX-G, a Wharton's jelly gel reconstituted in a syringe.	Biological: SygeLIX-F + SygeLIX-G; SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of intensity of perineal inflammation following treatment	Scoring of pain (0 = no pain, 10 = worst pain possible), redness (0 = no redness, 4 = redness covering an area > 5 cm), edema (0 = no edema, 4 = area completely swollen), ulceration (0 = no ulceration, 4 = ulcer larger than 1 cm).	Through study completion (45 days)
Rate of plug expulsion and surgical revision due to complications		Through study completion (45 days)
Type and incidence of adverse events (AE) and serious adverse events (SAE)		Through study completion (45 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of surgical technique	Questionnaire on surgical technique including ease of plug suture to the mucosa and of gel use.	Time of investigational products surgical implantation (Day 0)
Plug integration	Assessment of anal continence by the Vaizey score (0 = perfect continence, 24 = totally incontinent).	30 days, 45 days
Cessation of fistula flow	Healing of the fistula orifices assessed by palpation and pinching.	45 days

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: SygeLIX-Fistules-TBF; 2021-A02787-34 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No