NCT06822686Withdrawn
Autologous Stem Cells in the Management of Fistulating Perianal Crohn's Disease
Assessment of the Feasibility of Autologous Bone Marrow-derived Mesenchymal Stem Cells in the Management of Fistulating Perianal Crohn's Disease
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Reason given: Unable to obtain theatre access to carry out the trial.
Brief summary (registry, in English)
Crohn's disease is a chronic inflammatory condition that can affect any part of the bowel which can be controlled by a combination of medical and surgical treatments but cannot be cured. A 1/3 of patients have involvement of the perianal region. There are several conditions that can affect the perianal region but the most debilitating is the presence of fistulating disease. Fistulae are small tunnels that run under the skin from the inside of the anus to skin outside the anus and are associated with the inflammatory process seen with Crohn's disease. They can cause pain, infection and discharge which adversely affects the quality of life of the patient. Surgery can be used to treat the symptoms however cure is often difficult to achieve. Stem cells have anti-inflammatory potential and have been shown to be a useful treatment for this condition in combination with effective medical therapy. The stem cells used in the studies need to be prepared 48 hours before use which limits their usage and this is not readily available in the UK. The proposed study aims to assess the feasibility of using autologous stem cells prepared with a rapid preparation system at the time of surgery, within the operating room (currently in use at Oxford University Hospitals NHS Foundation Trust (OUH) within the orthopaedic department for a different indication) for fistulating anal Crohn's disease. The stem cells are derived from the patients own bone marrow. The patients undergoing surgery would be having it done for the stem cell treatment. They will then undergo 3 follow up visits and complete questionnaires at each visit alongside a clinical assessment. This study is funded by Occtopus (Colorectal charity based in Oxford).
- Status (registry)
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 20 Dec 2023
- Start date
- 1 Mar 2025
- Primary completion date
- 11 Jun 2026
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Diseases
- Crohn's disease
- NCT number
- NCT06822686
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Other
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Ongoing perianal sepsis or anal stenosis
- Patients with a defunctioning stoma
Who the study is looking for
- Diagnosed with perianal Crohn's disease
- Medically controlled proximal disease as confirmed by endoscopy or Harvey Bradshaw Index scores of less than 7 (remission / mild disease)
- Recent MRI scan to assess fistulating perianal Crohn's
- Non-branching fistula with no more than 1 internal opening and 2 external opening i.e. a single tract.
- No previous definitive fistula treatment (seton excluded)
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.