Ongoing Clinical Trials for Anal Fistula
There are currently 6 clinical trials investigating new treatments for anal fistula, including studies on stem cell therapy, biological medications, and antibiotic treatments. These trials are taking place in several European countries including the Netherlands, Denmark, Spain, Poland, Austria, France, Germany, and Czechia.
Clinical trial locations
- Austria
- Czechia
- Denmark
- France
- Germany
- Netherlands
- Study on Antibiotic Treatment with Metronidazole and Ciprofloxacin for Patients with Perianal Abscess After Surgery
- Study on Gallium (68Ga) Chloride for Early Healing of Perianal Crohn’s Disease Fistulas in Patients
- Study on the Effectiveness and Safety of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells for Treating Complex Perianal Fistulas in Children with Crohn’s Disease
- Poland
- Spain
Study on Gallium (68Ga) Chloride for Early Healing of Perianal Crohn’s Disease Fistulas in Patients
This trial is investigating a new imaging technique to monitor the healing of perianal fistulas in patients with Crohn’s disease. The study uses a specialized scan called 68Ga-FAPi-46 PET-CT to observe healing processes.
Main inclusion criteria: Participants must be 16 years or older with a confirmed diagnosis of Crohn’s disease showing inflammation in the digestive tract. They must have a complex perianal fistula that is actively draining fluid, involving the upper anal muscle, having multiple openings, or causing pain and swelling. All participants must provide informed consent.
Main exclusion criteria: The study excludes patients with other serious medical conditions that could interfere with participation, those who are pregnant or breastfeeding, patients with recent or planned surgery during the study, and those currently in another clinical trial. Patients with allergic reactions to study substances, inability to understand or follow procedures, mental health conditions affecting participation, substance abuse issues, unstable medical conditions, or recent infections are also excluded.
Focus and goal: The trial aims to evaluate how well the 68Ga-FAPi-46 PET-CT scan can visualize and measure the activity of fibroblasts during early healing stages. Participants undergo imaging at baseline and at different intervals during the study. The scan involves administering gallium (68Ga) chloride through an infusion to capture detailed images. Follow-up imaging occurs at weeks 2 and 6, with assessments at weeks 9 and 26 to understand treatment progress and long-term impact.
Investigational drug: The study uses 68Ga-FAPi-46, a radiopharmaceutical imaging agent that binds to fibroblast activation protein, helping doctors visualize healing tissue during PET-CT scans.
Study on Infliximab and Azathioprine for Treating Complex Anal Fistulas in Patients Without Crohn’s Disease
This Danish trial is studying whether adding infliximab medication to standard surgical treatment can improve outcomes for complex anal fistulas in patients who do not have Crohn’s disease.
Main inclusion criteria: Participants must be between 18 and 65 years old, speak and understand Danish, and have a complex anal fistula that has not healed despite at least 6 months of standard surgical treatment including repeated cleaning and seton placement. They must not have Crohn’s disease, confirmed by normal test results from colonoscopy, small bowel imaging, and tissue samples within the last 6 months.
Main exclusion criteria: The study excludes patients with significant health conditions interfering with the study, those who are pregnant or breastfeeding, patients with recent unrelated surgery, those in another trial, patients with known allergies to study medications, those with a history of non-compliance, individuals with compromised immune systems, history of substance abuse, severe liver or kidney disease, or cancer diagnosis in the past five years.
Focus and goal: The trial explores whether infliximab added to surgical treatment can help improve fistula healing enough to allow surgical closure. Participants receive treatment over several months with regular assessments including quality of life evaluations and MRI scans to monitor fistula activity and changes. Some participants receive a placebo for comparison purposes.
Investigational drugs: The study tests infliximab, a biologic medication given by infusion that blocks tumor necrosis factor-alpha (TNFα) to reduce inflammation. Azathioprine tablets and saline are also used in the study protocol.
Study on Treating Perianal Fistulas Using Adipose Derived Regenerative Cells, Metronidazole, and Cefuroxime for Patients with Complex Perianal Fistulas
This Danish trial is investigating regenerative cell therapy combined with minimal surgery and antibiotics to treat complex perianal fistulas.
Main inclusion criteria: Participants must be adults aged 18 or older with a complex crypto-glandular perianal fistula that is either high transsphincteric or suprasphincteric, involving more than 30% of the anal sphincter muscle. They must be referred to the surgical department at Odense University Hospital, be able to communicate in Danish, and have an address in southern Denmark during the study.
Main exclusion criteria: The study excludes patients with conditions other than crypto-glandular perianal fistula, individuals outside the specified age range, and those considered part of vulnerable populations requiring special protection or care.
Focus and goal: The trial evaluates the effectiveness of Adipose Derived Regenerative Cells (ADRC) and Culture expanded ADRC (ADRC001) derived from fat tissue to promote healing. Treatment involves minimal surgical cleaning of the fistula area followed by injection of regenerative cells. Participants also receive Metronidazole and Cefuroxime antibiotics to prevent infection. The study measures healing rates at 6 and 12 months, along with quality of life and anal continence using standardized questionnaires. MRI scans monitor for remaining fistulas or fluid collections.
Investigational drugs: The study uses regenerative cellular therapeutics containing adipose-derived stem cells to aid tissue repair and healing. Metronidazole 500 mg tablets and Zinnat (Cefuroxime) 500 mg are used as antibiotic support.
Study on Antibiotic Treatment with Metronidazole and Ciprofloxacin for Patients with Perianal Abscess After Surgery
This Dutch trial is investigating whether antibiotic treatment after surgical drainage of a perianal abscess can prevent the development of a perianal fistula.
Main inclusion criteria: Participants must be over 18 years old, able to receive and respond to email questionnaires, have good understanding of Dutch language (reading and writing), and provide written informed consent.
Main exclusion criteria: Individuals without a perianal abscess cannot participate. Vulnerable populations who might not be able to give informed consent are excluded.
Focus and goal: The study examines whether adding antibiotic treatment to standard surgical drainage can reduce the occurrence of perianal fistulas, which are abnormal connections that can form between the anal canal and skin. After surgical drainage, participants receive either antibiotics (Metronidazole and Ciprofloxacin) or placebo. Follow-up monitoring assesses fistula development within one year, along with quality of life at 12 months, costs, need for repeated drainage, recurrent abscess, complications, patient-reported outcomes, hospital stay length, readmissions, and time to return to work. The study concludes in July 2026.
Investigational drugs: The study uses Metronidazole 500 mg and Ciprofloxacin 500 mg, both given orally as film-coated tablets to fight bacterial infections and potentially prevent fistula formation.
Study on the Effectiveness and Safety of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells for Treating Complex Perianal Fistulas in Children with Crohn’s Disease
This international trial across the Netherlands, Spain, and Poland is studying stem cell therapy for children and teenagers with Crohn’s disease who have complex perianal fistulas.
Main inclusion criteria: Participants must be between 4 and under 18 years old at treatment time, with Crohn’s disease diagnosed at least 6 months prior based on clinical exams, endoscopy, tissue samples, or imaging. They must have complex perianal fistulas that have not improved with at least one previous treatment such as immunosuppressants or biologic medications. The fistulas must meet specific criteria including particular locations shown by MRI, having 2-3 external openings, or presence of abscesses. Participants must have inactive or mildly active intestinal Crohn’s disease. Both patients and their parents/guardians must provide consent, and sexually active participants must agree to use appropriate birth control methods during the study.
Main exclusion criteria: Patients outside the 4-17 age range, those without complex perianal fistulas related to Crohn’s disease, patients unable to follow study procedures or attend required visits, those with other health conditions interfering with the study, patients taking certain medications affecting study results, those with recent surgery or medical procedures, pregnant or breastfeeding patients, those with history of substance abuse, and recent participants in other trials are excluded.
Focus and goal: The trial evaluates darvadstrocel, a cell therapy using allogeneic adipose tissue-derived mesenchymal stem cells from healthy donors. The treatment is injected directly into the fistula area to promote healing. Participants are monitored over 24 weeks with follow-up extending to 52 weeks. Regular assessments include checking for fistula closure and treatment side effects. Some participants may receive placebo for comparison. MRI scans monitor fistula condition throughout the study.
Investigational drug: Darvadstrocel is a stem cell therapy administered by injection that uses cells designed to reduce inflammation and promote healing in the affected fistula area.
Study on the Long-Term Safety of Darvadstrocel for Adults with Crohn’s Disease and Complex Perianal Fistulas
This multi-country trial across Austria, France, Spain, Germany, and Czechia is studying the long-term safety of repeated darvadstrocel treatment in adults with Crohn’s disease and complex perianal fistulas.
Main inclusion criteria: Participants must be 18 years or older, capable of understanding and following study requirements, and sign written informed consent. They must have complex perianal fistulas with maximum 2 internal and 3 external openings that have been draining for at least 6 weeks. Participants must have previously received darvadstrocel treatment at least 6 months before study start, with their doctor planning another treatment for the same or new fistula. They must have controlled or mildly active Crohn’s disease with a specific score less than 14. Sexually active participants must agree to use appropriate contraception from consent signing until 1 year after repeat treatment.
Main exclusion criteria: Patients with other serious health conditions interfering with the study, those pregnant or planning pregnancy during the study, patients with recent infections requiring antibiotics, history of allergic reactions to similar treatments, current participation in another trial, history of substance abuse, recent related surgery, or inability to comply with study procedures are excluded.
Focus and goal: The study evaluates the safety of giving darvadstrocel more than once to patients who received it previously. The treatment uses allogeneic adipose tissue-derived mesenchymal stem cells prepared for injection directly into the fistula area. Participants are monitored long-term to check for side effects or complications. The study assesses treatment effectiveness in closing fistulas and preventing reopening at 6, 24, 52, 104, and 156 weeks after repeat administration. Regular check-ups and MRI scans ensure treatment effectiveness and monitor for new issues. The study concludes in September 2026.
Investigational drug: Darvadstrocel is a stem cell therapy using cells from fat tissue to help close fistulas and reduce symptoms by promoting healing in the affected area. The trial focuses on understanding safety of multiple uses over a long period.
Summary
The 6 ongoing clinical trials for anal fistula represent diverse treatment approaches across multiple European countries. A notable concentration of trials is occurring in the Netherlands and Denmark, with additional studies in Spain, Poland, Austria, France, Germany, and Czechia.
Several trials focus on regenerative medicine approaches using stem cell therapies, particularly darvadstrocel containing adipose-derived mesenchymal stem cells. These studies target both adult and pediatric populations with Crohn’s disease-related fistulas. Other research directions include biological medications like infliximab for patients without Crohn’s disease, antibiotic treatments to prevent fistula formation after abscess drainage, and advanced imaging techniques using gallium chloride to monitor healing.
The trials address both acute treatment effectiveness and long-term safety, with follow-up periods ranging from several months to over three years. This comprehensive research approach aims to improve outcomes for patients dealing with this challenging condition, whether related to Crohn’s disease or occurring independently.
