Phase 2 Crohn's Disease and Colitis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Crohn's disease using standard medical criteria
- Your Crohn's disease is currently active, based on symptoms measured by a scoring system (called CDAI) showing a score above 250 (if you have an ostomy bag, the number of times you empty it daily is used instead of stool count)
- A camera examination of your bowel (endoscopy) shows active inflammation, measured by a specific score above 3 in at least one part of the bowel
- You have tried, been unable to tolerate, or declined treatments from each of the following groups of medications: steroids (e.g. prednisone); azathioprine; 6-mercaptopurine or methotrexate; anti-TNF drugs (such as infliximab or adalimumab); anti-integrin drugs (such as vedolizumab); and ustekinumab
- Surgery is not a safe option for you because of the risk of losing too much of your bowel, or you have chosen not to have surgery
Who may not be able to join:
- You have had a serious bad reaction to any of the medications used in this trial (cyclophosphamide, thymoglobulin, or vedolizumab)
- You are pregnant or breastfeeding
- You are under 18 years old
- Your general health and ability to carry out daily activities is below a certain level, as measured by a standard health scoring tool (confirm with trial site)
- You have an ongoing infection that has not been controlled despite at least one month of appropriate treatment
- You have chest pain or other symptoms from heart artery disease, or heart failure that is not well controlled
- You are HIV positive
- Your heart is not pumping strongly enough (pumping less than 30% of its capacity), or you need continuous extra oxygen to breathe
- Your lungs are not working well enough based on a breathing test result (below 35% of expected), or you need extra oxygen
- Not enough stem cells (a type of cell collected from your blood) were able to be collected for the treatment
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Aaron Etra, MD, Icahn School of Medicine at Mount Sinai
Phone: (212) 241-8100
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in Crohn's Disease Activity Index (CDAI)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.