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

Phase 1

Completed

• Conditions: Anal Fistula
• Interventions: Biological: SygeLIX-F + SygeLIX-G

• Registration Number: NCT05638139
• Lead Sponsor: TBF Genie Tissulaire

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-24
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-06
• Study Start: 2023-06-27
• Primary Completion: 2024-06-25
• Study Completion: 2024-06-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SygeLIX-F + SygeLIX-G	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.

Primary Outcome Measures

Name	Time	Method
Type and incidence of adverse events (AE) and serious adverse events (SAE)	Through study completion (45 days)
Evaluation of intensity of perineal inflammation following treatment	Through study completion (45 days)	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).
Rate of plug expulsion and surgical revision due to complications	Through study completion (45 days)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Clinique Blomet; 🇫🇷 Paris, France

Maison de Santé Protestante de Bordeaux-Bagatelle; 🇫🇷 Talence, France