Tissue Therapy of Transsphincteric Anal Fistula

NCT06303752 | Recruiting Phase 1 DMC

• 2 other identifiers: 260-2021-NQ2022-502659-73
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Fistula

Keywords

anal fistula; stem cells; ADRC

Outcome Measures

Primary Outcomes (1)

• Healing rate (percentage)

  Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.

  at 6 and 12 months follow-up

Secondary Outcomes (7)

• QoL

  at12 months follow-up.

• Fecal Incontinence

  at12 months follow-up.

• Risk factors for recurrence of fistula.

  at12 months follow-up.

• Radiological healing.

  at12 months follow-up.

• Treatment efficacy.

  at12 months follow-up.

Study Arms (2)

Autologous ADRC

EXPERIMENTAL

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.

Drug: ADRC injection

allogenic ADRC001

EXPERIMENTAL

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.

Drug: ADRC001 injection

Interventions

ADRC injection 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.

Also known as: Liposuction, Surgical debridement of fistula tract and closure of internal orifice, Injection of lipoaspirate

Autologous ADRC

ADRC001 injection 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.

Also known as: Liposuction, Surgical debridement of fistula tract and closure of internal orifice, Injection of lipoaspirate

allogenic ADRC001

Eligibility Criteria

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

You may not qualify if:

• Signs of suppuration/cavitation around the fistula
• Simple or low anal fistula, which can be treated by simple surgical incision
• Ano-vaginal and recto-vaginal fistula
• The presence of more than one fistula tract, more than two external orifices or more than one internal orifice
• Inflammatory Bowel Disease
• Immunosuppression (due to clinical condition or medical therapy)
• Malignancy within 5 years
• Previous radiotherapy of the abdomen and pelvis
• BMI under 18.5
• Allergy against the antibiotics: Penicillin and streptomycin.
• Coagulopathy
• Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test)
• Verified syphilis, HIV, or hepatitis on screening test

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Interventions

Lipectomy

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

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Karam M Sørensen

  OUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karam M Sørensen, Ph.D

CONTACT

+4565415190; ouh.a.forskningsenheden@rsyd.dk

Tina D Hansen

CONTACT

+4565415190; ouh.a.forskningsenheden@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator (PI)

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 12, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): October 8, 2027
• Study Completion (Estimated): October 8, 2028
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)