Tissue Therapy of Transsphincteric Anal Fistula

NCT ID: NCT06303752

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-09
• Study Completion Date: 2028-10-08

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.

Conditions

Anal Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Autologous ADRC

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.

Group Type: EXPERIMENTAL

ADRC injection

Intervention Type: DRUG

Allocated patients 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

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.

Group Type: EXPERIMENTAL

ADRC001 injection

Intervention Type: DRUG

Allocated patients will receive injection of 5 ml suspension including 30 million allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.

Interventions

ADRC injection

Allocated patients 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.

Intervention Type: DRUG

ADRC001 injection

Allocated patients will receive injection of 5 ml suspension including 30 million allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.

Intervention Type: DRUG

Other Intervention Names

Liposuction; Surgical debridement of fistula tract and closure of internal orifice; Injection of lipoaspirate; Liposuction; Surgical debridement of fistula tract and closure of internal orifice; Injection of lipoaspirate

Eligibility Criteria

Inclusion Criteria

Adult patients (>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment, and who are:

• able to communicate with Danish language
• able to provide informed consent
• having address in the region of southern Denmark during the study

Exclusion Criteria

1. Signs of suppuration/cavitation around the fistula

2. Simple or low anal fistula, which can be treated by simple surgical incision

3. Ano-vaginal and recto-vaginal fistula

4. The presence of more than one fistula tract, more than two external orifices or more than one internal orifice

5. Inflammatory Bowel Disease

6. Immunosuppression (due to clinical condition or medical therapy)

7. Malignancy within 5 years

8. Previous radiotherapy of the abdomen and pelvis

9. BMI under 18.5

10. Allergy against the antibiotics: Penicillin and streptomycin.

11. Coagulopathy

12. Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test)

13. Verified syphilis, HIV, or hepatitis on screening test

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Karam Matlub Sørensen, PhD

Primary Investigator (PI)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karam M Sørensen

Role: PRINCIPAL_INVESTIGATOR

OUH

Locations

Odense University Hospital

Odense, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Karam M Sørensen, Ph.D

Role: CONTACT

ouh.a.forskningsenheden@rsyd.dk

+4565415190

Tina D Hansen

Role: CONTACT

ouh.a.forskningsenheden@rsyd.dk

+4565415190

Facility Contacts

Karam M Sørensen, Ph.D

Role: primary

ouh.a.forskningsenheden@rsyd.dk

+4565415190

Tina D Hansen

Role: backup

ouh.a.forskningsenheden@rsyd.dk

+4565415190

Other Identifiers

2022-502659-73

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

260-2021-NQ

Identifier Type: -

Identifier Source: org_study_id