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

NCT05638139 | Completed Phase 1

• 2 other identifiers: SygeLIX-Fistules-TBF2021-A02787-34
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Anal Fistula

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Evaluation of surgical technique

  Time of investigational products surgical implantation (Day 0)

• Plug integration

  30 days, 45 days

• Cessation of fistula flow

  45 days

Study Arms (1)

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.

Biological: SygeLIX-F + SygeLIX-G

Interventions

SygeLIX-F + SygeLIX-G BIOLOGICAL

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

SygeLIX-F + SygeLIX-G

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Sites (2)

Clinique Blomet

Paris, 75015, France

Location

Maison de Santé Protestante de Bordeaux-Bagatelle

Talence, 33401, France

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 6, 2022
• Study Start: June 27, 2023
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)