Tissue Therapy of Transsphincteric Anal Fistula

Anal Fistula Clinical Trial

— REP-PAF  

Official title:

Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06303752
• Other study ID #: 260-2021-NQ
• Secondary ID: 2022-502659-73
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: April 2024
• Source: University of Southern Denmark
• Contact: Karam M Sørensen, Ph.D
• Phone: +4565415190
• Email: ouh.a.forskningsenheden[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criterion:

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

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	QoL	functional outcome regarding quality of life, measured by Short Form SF-36 Rand questionnaire.	at12 months follow-up.
Secondary	Fecal Incontinence	functional outcome regarding fecal incontinence, measured by Wexner Fecal Incontinence score.	at12 months follow-up.
Secondary	Risk factors for recurrence of fistula.	Risk factors for recurrence of fistula including demography, prevoius surgery for fistula, disease duration and treatment arm.	at12 months follow-up.
Secondary	Radiological healing.	Radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging.	at12 months follow-up.
Secondary	Treatment efficacy.	comparison of the healing rate of the fistula between patients receiving ADRC and patients receiving ADRC001 (autologous vs. allogenic cells)	at12 months follow-up.
Secondary	Cellular composition	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.	at 3 months follow-up.
Secondary	Transplantation-related alloantibodies	Registration of the number of patients developing serum alloantibodies specific to donor genotypes, by assessment of anti-HLA (class I and II).	at12 months follow-up.