Treatment for complex anal fistulas using regenerative cells
Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics
PHASE1; PHASE2 · University of Southern Denmark · NCT06303752
This study is testing a new treatment for complex anal fistulas that uses cells from the patient's own body or specially grown cells to see if it helps heal the condition better than current methods.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern Denmark (other) |
| Locations | 1 site (Odense) |
| Trial ID | NCT06303752 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effectiveness of a combined approach involving minimal surgical debridement and regenerative cellular therapeutics for treating complex perianal fistulas. Eligible adult patients will undergo a preoperative assessment and, if accepted, will receive treatment that includes liposuction from the abdominal wall followed by injection of regenerative cells around the fistula tract. The study will randomize participants to receive either their own regenerative cells or cultured regenerative cells in a double-blinded manner. Follow-up assessments will occur at 3, 6, and 12 months post-treatment to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with complex anal fistulas involving more than 30% of the anal sphincter.
Not a fit: Patients with simple anal fistulas or those with conditions such as inflammatory bowel disease or malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing rates and quality of life for patients suffering from complex anal fistulas.
How similar studies have performed: While regenerative cell therapies are emerging, this specific combination approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Odense
- Odense University Hospital — Odense, Denmark (RECRUITING)
Study contacts
- Principal investigator: Karam M Sørensen — OUH
- Study coordinator: Karam M Sørensen, Ph.D
- Email: ouh.a.forskningsenheden@rsyd.dk
- Phone: +4565415190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anal Fistula, anal fistula, stem cells, ADRC