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

TBF Genie Tissulaire

Status and phase: Completed; Phase 1

Conditions: Anal Fistula

Treatments: Biological: SygeLIX-F + SygeLIX-G

Study type: Interventional

Funder types: Industry

Identifiers

NCT05638139

2021-A02787-34 (Other Identifier)

SygeLIX-Fistules-TBF

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

SygeLIX-F + SygeLIX-G

Experimental group

Description:

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.

Treatment:

Biological: SygeLIX-F + SygeLIX-G