Treatment for complex anal fistulas using regenerative cells
Official title: Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics
Run by University of Southern Denmark · NCT06303752 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 1 site (Odense) |
| Status | Recruiting |
| Started | October 9, 2024 |
| Main results expected | October 8, 2027 |
| Study ends | October 8, 2028 |
| Registry record updated | November 5, 2024 |
| Trial ID | NCT06303752 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with complex anal fistulas involving more than 30% of the anal sphincter.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While regenerative cell therapies are emerging, this specific combination approach is novel and has not been extensively tested in similar studies.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Electronic bidets after anal surgery vs water rinsing
A small study tests whether using an electronic bidet after anal fistula or hemorrhoid surgery helps patients more than standard water rinsing.
-
Recurrence and Patient-Reported Outcomes after Anal Fistula Surgery
This observational project will see if different surgical treatments for perianal fistulas lead to better healing, continence, and quality of life for adults having definitive fistula surgery.
-
Repeat liposomal bupivacaine for pain after anal fistula surgery.
We will see if giving a second dose of liposomal bupivacaine 72 hours after anal fistula surgery reduces postoperative pain in adults.
-
Improving recovery after surgery for benign anorectal conditions
This study is testing if a special recovery plan can help people aged 18 to 65 have fewer problems with urinary retention after surgery for conditions like hemorrhoids and anal fissures.
-
Treatment of anal fistulas using stem cells
This study is testing if a new stem cell treatment can help people with complex anal fistulas caused by Crohn's disease feel better after surgery.
-
Evaluating RD2 Ver.02 for managing anal fistulas
This study is testing a new treatment called RD2 Ver.02 to see if it can help people with certain types of anal fistulas heal better than a saline solution.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.