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Can stem cells harvested during surgery heal Crohn's fistulas?

NCT ID NCT06822686

Disease control Sponsor: Oxford University Hospitals NHS Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial explores whether stem cells taken from a patient's own bone marrow during surgery can help treat fistulas—abnormal tunnels under the skin—caused by Crohn's disease. The stem cells are prepared quickly in the operating room and injected into the fistula tract. Researchers aim to see if this approach is practical and safe, with follow-up over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a patient's own bone marrow-derived stem cells, harvested and injected during surgery
What this could lead to
If successful, this could offer a new, one-step surgical option to heal fistulas in Crohn's disease, potentially improving quality of life.
What could go wrong
This is a small feasibility study, not yet testing effectiveness. The procedure may be difficult to perform or carry risks like infection or lack of healing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Mar 2025

An estimate. Start dates often move.

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

anal fistula Crohn disease perianal Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease Fistula in ano

More trials for these conditions

Other studies related to the condition(s) this trial covers.