Could your own fat cells heal Crohn's fistulas? new trial tests it
NCT ID NCT04612465
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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46 people
The number who actually took part.
- Started
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Jan 2020
- Expected to finish
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Sep 2025
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Asan Medical Center
Seoul, Seoul, 05505, South Korea
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Samsung Medical Center
Seoul, Seoul, 06351, South Korea
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Seoul Natinoal Univetsity Hospital
Seoul, Seoul, 03080, South Korea
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Severance
Seoul, Seodaemun-gu, 03722, South Korea
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