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

NCT06822686 | Not Yet Recruiting

• 1 other identifier: Stemcell
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Fistula in Ano; Crohn Disease

Keywords

Stem cell

Outcome Measures

Primary Outcomes (1)

• Feasibility of using autologous mesenchymal stem cells in the management of fistulating perianal Crohn's disease.

  Operative time and difficulties encountered intraoperatively will be documented on the operation note. Subjective impression of the operating surgeon alongside feedback from the nursing team in theatre will help assess the procedure. Feedback from the operative team will be documented on the WHO checklist (where a section for feedback exists).

  During surgery

Secondary Outcomes (4)

• Safety of stem cell treatment

  after surgery for 6 months with clinical review at 6 weeks, 3 months and 6 months

• Safety of stem cell treatment

  after surgery for 6 months with clinical review at 6 weeks, 3 months and 6 months

• Safety of stem cell treatment

  after surgery for 6 months with clinical review at 6 weeks, 3 months and 6 months

• Safety of stem cell treatment

  after surgery for 6 months with clinical review at 6 weeks, 3 months and 6 months

Study Arms (1)

Injection of stem cell into fistulating perianal Crohn's disease

EXPERIMENTAL

At surgery participants will undergo an examination of the anorectum under anaesthesia and if suitable the stem cells will be harvested. Harvest of the bone marrow-derived mesenchymal stem cells is performed by aspirating 60ml of bone marrow. The aspirate is then centrifuged in theatre and the mesenchymal stem cells prepared in theatre by a representative from (Synergy Medical Technologies). Once prepared they are administered immediately into and around the fistula tract. The internal opening is then closed. If the participant is not suitable they will undergo best surgical practice and will be excluded from the study. They will then undergo follow-up as dictated by their clinical condition. All participants will undergo the procedure as a day case.

Device: Harvest and injection of stem cells

Interventions

Harvest and injection of stem cells DEVICE

Stem cells will be harvested from bone marrow aspirate and injected into the fistula tract The stem cells are the device intervention for this trial and we are looking to assess the procedure of harvesting and injecting the stem cells Patients will undergo study questionnaire: Harvey-Bradshaw Index, perianal Crohn's disease activity index, and Short IBD questionnaire will be administered before surgery and then at 6 weeks, 3 and 6 months after stem cell intervention.

Injection of stem cell into fistulating perianal Crohn's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
• Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
• Ongoing perianal sepsis or anal stenosis
• Patients with a defunctioning stoma

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

MeSH Terms

Conditions

Rectal Fistula; Crohn Disease

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammatory Bowel Diseases; Gastroenteritis

Central Study Contacts

Mark Bignell

CONTACT

01865221150; mark.bignell@ouh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Feasibility trial to assess the use of autologous stem cells in the management of fistulating perianal Crohn's. Observational study. No Comparator.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: February 12, 2025
• Study Start: March 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share