Tissue Therapy of Transsphincteric Anal Fistula

Phase 1

Recruiting

• Conditions: Anal Fistula
• Interventions: Drug: ADRC injection; Drug: ADRC001 injection

• Registration Number: NCT06303752
• Lead Sponsor: University of Southern Denmark

Brief Summary

This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo screening serology and preoperative work-up to determine eligibility for study entery. Patients who meet the eligibility requirements will be treated for their fistulas by combined minor surgical debridement of the fistula tract and closure of the internal orifice as well as liposuction from the abdominal wall. Regenerative cells- enriched lipoaspirate will be injected around the entire length of the fistula tract. The first five patients will receive their own regenerative cells and act as donors for the next included patients, but they will not be included in the final analysis. The rest of the included patients (70) will be randomized in double-blinded manner (participant and investigator) in a 1:1 ratio to either recieve own regenerative cells (ADRC Adipose-Derived Regeneative Cells) or donated cultured regenerative cells (ADRC001). All included patients will be scheduled for follow-up at 3, 6 and 12 months after treatment.

Study Timeline

• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-12
• Study Start: 2024-10-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-02
• Last Update Posted: 2024-11-05
• Primary Completion: 2027-10-08
• Study Completion: 2028-10-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous ADRC	ADRC injection	Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection.
allogenic ADRC001	ADRC001 injection	Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million cultured allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.

Primary Outcome Measures

Name	Time	Method
Healing rate (percentage)	at 6 and 12 months follow-up	Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.

Secondary Outcome Measures

Name	Time	Method
QoL	at12 months follow-up.	functional outcome regarding quality of life, measured by Short Form SF-36 Rand questionnaire.
Transplantation-related alloantibodies	at12 months follow-up.	Registration of the number of patients developing serum alloantibodies specific to donor genotypes, by assessment of anti-HLA (class I and II).
Fecal Incontinence	at12 months follow-up.	functional outcome regarding fecal incontinence, measured by Wexner Fecal Incontinence score.
Risk factors for recurrence of fistula.	at12 months follow-up.	Risk factors for recurrence of fistula including demography, prevoius surgery for fistula, disease duration and treatment arm.
Radiological healing.	at12 months follow-up.	Radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging.
Treatment efficacy.	at12 months follow-up.	comparison of the healing rate of the fistula between patients receiving ADRC and patients receiving ADRC001 (autologous vs. allogenic cells)
Cellular composition	at 3 months follow-up.	Definition of the cellular compisition of the ADRC and ADRC001 regarding cellular surface markers (CD14, CD31, CD34, CD45, CD73, CD90, CD105, CD235a, HLA-ABC og HLA-DR) using flowcytometry.

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark