Could your own stem cells tame Crohn's?
NCT ID NCT04224558
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a stem cell transplant for people aged 13-28 with severe Crohn's disease that hasn't responded to other treatments. Doctors take the patient's own blood stem cells, then use high-dose therapy to wipe out overactive immune cells before returning the stem cells. The goal is to reset the immune system to reduce inflammation and improve symptoms, though ongoing management may still be needed.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2019
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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13 to 28 years
- 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. Aged 13-28 years are eligible 2. Confirmed diagnosis of active Crohn's disease: 1. Diagnosis of Crohn's disease based on typical radiological appearances and / or typical histology at least 6 months prior to screening. 2. Active disease at the time of registration to the trial, defined as i) PCDAI \> 30, and ii) Two of the following: 1. elevated CRP 2. endoscopic evidence of active disease confirmed by histology 3. clear evidence of active small bowel Crohn's disease on CT or MR enterography. 3. Unsatisfactory course despite 3 immunosuppressive agents (usually azathioprine, methotrexate and infliximab, adalimumab and/or certolizumab) in addition to corticosteroids. Patients should have relapsing disease (i.e. 1 exacerbation/year) despite thiopurines, methotrexate and/or infliximab/adalimumab/certolizumab maintenance therapy or clear demonstration of intolerance / toxicity to these drugs. 4. Current problems unsuitable for surgery or patient at risk for developing short bowel syndrome. 5. Accepted by a majority of the members of the combined IBD Center as an appropriate candidate (see Selection description below). 6. Informed consent 1. Prepared to undergo additional study procedures as per trial schedule 2. Patient has undergone intensive counseling about risks Exclusion Criteria: 1. Pregnancy or unwillingness to use adequate contraception during the study, in women of childbearing age. Unwillingness of using appropriate contraceptive measures in males. 2. Concomitant severe disease 1. renal: creatinine clearance \< 30 mL/min (measured or estimated) 2. cardiac: clinical evidence of refractory congestive heart failure; left ventricular ejection fraction \< 40% by cardiac echo; chronic atrial fibrillation necessitating oral anticoagulation; uncontrolled ventricular arrhythmia; pericardial effusion with hemodynamic consequences as evaluated by an experienced echo cardiographer 3. pulmonary: diffusion capacity \<40% 4. psychiatric disorders including active drug or alcohol abuse 5. concurrent or recent history of malignant disease (excluding non-melanoma skin cancer) 6. uncontrolled hypertension, defined as resting systolic blood pressure ≥ 140 and/or resting diastolic pressure ≥ 90 despite at least 2 anti-hypertensive agents. 7. any infection with HIV, HTLV-1 or 2, hepatitis viruses, or any other infection the investigators consider a contraindication to participation. 8. other chronic disease causing significant organ failure. 3. Infection or risk thereof: 1. Current clinical relevant abscess or significant active infection. 2. Perianal fistula without free drainage. Perianal fistulas is not an exclusion provided there is natural free drainage or a seton suture(s) have been placed. 3. History of tuberculosis or at current increased risk of tuberculosis 4. Quantiferon Gold test result or other investigations that the investigators regard as evidence of active tuberculosis. 5. Abnormal chest X-ray (CXR) consistent with active infection or neoplasm. 6\) Significant malnutrition: Body Mass Index (BMI) ≤ 18, serum albumin \< 20 g/l. 7\) Previous poor compliance. 8) Concurrent enrollment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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