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Could your own fat cells heal Crohn's fistulas? new trial tests it

NCT ID NCT04612465

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether injecting a patient's own fat-derived stem cells, along with a glue, can close fistulas caused by Crohn's disease. 46 adults with Crohn's and at least one fistula are taking part. The main goal is to see if the fistula closes completely.

What this could mean

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

Active substance
Autologous adipose-derived stem cells (a patient's own fat stem cells) combined with fibrin glue
What this could lead to
If it works, this could offer a new way to close hard-to-treat fistulas in Crohn's disease, potentially reducing the need for surgery or long-term medication.
What could go wrong
This is a small Phase 3 trial with only 46 people, so results may not apply to everyone. Stem cell treatments can have side effects like infection or inflammation, and the fistula might not fully close.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

46 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Sep 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Patient who has obtained the consent of their legal representative if they are over 18 years of age and under 20 years of age. 2. Patient is diagnosed with Crohn's disease. 3. Patient who has one or more Crohn's fistulas . 4. In the case of women of childbearing potential, patient who is negative for beta-HCG pregnancy tests at the screening visit. 5. Patient is able to give written informed consent prior to study start and willing to comply with the study requirements. Exclusion Criteria: 1. Patient who participated in other clinical trials within 30 days prior to the start of this clinical trial, or who has not passed a period equal to five times of the half-life of the drug dosed in other clinical trials. 2. Patient with a medical history or family history of Variant Creutzfeld Jakob Disease or related to this disease. 3. Patient who is sensitive to anesthetic drugs or bovine-derived materials. 4. Patient with autoimmune disease except for Crohn's disease. 5. Patient with infectious diseases such as HBV, HCV and HIV. 6. Patient with signs of Septicemia. 7. Patient with Active Tuberculosis.(Including patient with Anal Tuberculosis) 8. Pregnant or breast-feeding. 9. . Is unwilling to use an acceptable method of birth control during the whole study. 10. Patient with Inflammatory Bowel disease except for Crohn's disease. 11. Patient who is sensitive to Fibringlue. 12. Patient with a clinically relevant history of alcohol or drugs abuse, habitual smoking. 13. Patient whose adipose tissue obtained by liposuction is insufficient to manufacture the Investigational product at the intended dose. 14. Patient who is not able to understand the objective of the study or to comply with the study requirements. 15. Patient who is considered by the investigator to have a significant disease which might impact the study. 16. Patient who is considered not suitable for the study by investigator. 17. Patient who is Active Crohn's disease with CDAI 450 or higher. 18. Patient with medical history of surgery for malignant cancer in the past 5 years.(Except for carcinoma in situ) 19. Patient who exceeds 2 cm in the longest diameter of fistula. 20. Patient who dosed anti-TNF formulations such as infliximab, adalimumab, certolizumab within 3 months prior to injection.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, Seoul, 05505, South Korea

  • Samsung Medical Center

    Seoul, Seoul, 06351, South Korea

  • Seoul Natinoal Univetsity Hospital

    Seoul, Seoul, 03080, South Korea

  • Severance

    Seoul, Seodaemun-gu, 03722, South Korea

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