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Clinical Trial

Autologous Stem Cells in the Management of Fistulating Perianal Crohn's Disease

NCT: NCT06822686 · WITHDRAWN

NCT IDNCT06822686
StatusWITHDRAWN
Start Date2025-03-01
Completion2026-06-11
SponsorOxford University Hospitals NHS Trust (OTHER)
First posted
Last updated

Brief Summary

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).

Frequently Asked Questions

What is Autologous Stem Cells in the Management of Fistulating Perianal Crohn's Disease?

Autologous Stem Cells in the Management of Fistulating Perianal Crohn's Disease is a clinical trial registered under NCT06822686. Current status: WITHDRAWN.

What is the status of NCT06822686?

The current status of NCT06822686 (Autologous Stem Cells in the Management of Fistulating Perianal Crohn's Disease) is: WITHDRAWN.

When did Autologous Stem Cells in the Management of Fistulating Perianal Crohn's Disease start?

Autologous Stem Cells in the Management of Fistulating Perianal Crohn's Disease started on 2025-03-01.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.