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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-27

Study Completion Date

2024-06-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Anal Fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SygeLIX-F + SygeLIX-G

Intervention Type BIOLOGICAL

SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel).

Interventions

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SygeLIX-F + SygeLIX-G

SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No