---
title: "Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly"
nct_id: NCT05638139
overall_status: COMPLETED
phase: PHASE1
sponsor: TBF Genie Tissulaire
study_type: INTERVENTIONAL
primary_condition: Anal Fistula
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05638139.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05638139"
ct_last_update_post_date: 2024-11-14
last_seen_at: "2026-05-12T06:27:48.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly

**NCT ID:** [NCT05638139](https://clinicaltrials.gov/study/NCT05638139)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 9
- **Lead Sponsor:** TBF Genie Tissulaire
- **Conditions:** Anal Fistula
- **Start Date:** 2023-06-27
- **Completion Date:** 2024-06-25
- **CT.gov Last Update:** 2024-11-14

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **SygeLIX-F + SygeLIX-G** (EXPERIMENTAL) — 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.

## Interventions

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

## Primary Outcomes

- **Evaluation of intensity of perineal inflammation following treatment** _(time frame: 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** _(time frame: Through study completion (45 days))_
- **Type and incidence of adverse events (AE) and serious adverse events (SAE)** _(time frame: Through study completion (45 days))_

## Secondary Outcomes

- **Evaluation of surgical technique** _(time frame: Time of investigational products surgical implantation (Day 0))_
- **Plug integration** _(time frame: 30 days, 45 days)_
- **Cessation of fistula flow** _(time frame: 45 days)_

## Locations (2)

- Clinique Blomet, Paris, France
- Maison de Santé Protestante de Bordeaux-Bagatelle, Talence, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.clinique blomet|paris||france` — added _(2026-05-12)_
- `locations.maison de santé protestante de bordeaux-bagatelle|talence||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05638139.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05638139*  
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