Phase 2 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You (or your guardian) must be able to understand and agree to take part in the study
• You must be between 10 and 60 years old (inclusive) at the time of signing the consent form
• You have Crohn's disease that has come back severely after surgery, even with strong ongoing treatment
• You have widespread Crohn's disease affecting much of your bowel and have not responded to strong medical treatment, and surgery is not safely possible
• Your Crohn's disease activity scores remain high, or your disease is at a moderate level but you cannot stop taking daily steroid medication
• You have serious complications from Crohn's disease (such as abnormal connections between organs, severe skin problems, severe joint pain, or serious bone problems) that have not responded to treatment
• You had serious side effects from Crohn's medications (such as certain immune-suppressing or biologic drugs) that prevent you from continuing them
• You have a stoma (a surgically created opening in your abdomen for waste) and are still eligible
• Surgery is not an option due to risk of your bowel being too short to function, or because you have chosen not to have surgery
• Your blood platelet count is high enough (above 100,000/mm³)
• Your white blood cell (neutrophil) count is high enough (above 1,500/mm³, with some exceptions)
• Your kidney function is within an acceptable range (creatinine at or below 2.0 mg/dL)
• Your heart function is within an acceptable range (no history of heart artery disease, and heart pumping strength meets minimum levels)
• Your lung function is within an acceptable range based on breathing tests
• If you are female and aged 10 or older, or have started your period, you must have a negative pregnancy test (unless you have had surgery that means you cannot become pregnant)
• All females who could become pregnant, and all sexually active males, must agree to use an approved form of birth control for up to 24 months after the transplant, or for as long as required by any medication that could affect a pregnancy

Who may not be able to join:

• You have not yet tried standard medications (such as 6-MP, 5-ASA products, and metronidazole) at appropriate doses
• Your Crohn's disease responded well and stayed in remission without steroids after at least 4 months of biologic therapy (such as anti-TNF, anti-integrin, or anti-IL12/23 treatments)
• You have a severely swollen, dilated colon (toxic megacolon) or a hole in your intestine (perforation)
• Your liver function is outside the acceptable range (certain bilirubin levels too high)
• You are currently pregnant or breastfeeding
• You have tested positive for certain serious infections, including HIV, HTLV, Hepatitis B, or Hepatitis C
• You have an active infection confirmed by testing within two weeks before starting the preparation for the transplant
• You have other health problems, physical findings, or test results that the study doctor believes could put you at extra risk, affect your ability to take part, or affect the study results (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.