Plain-English translation of NCT04224558 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Crohn Disease research guide →Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This trial is testing a procedure called autologous hematopoietic stem cell transplantation (HSCT) for people with severe Crohn's disease that hasn't responded to conventional treatments. The procedure involves collecting your own stem cells, resetting your immune system with intensive conditioning, and then returning your stem cells to help your body rebuild a healthier immune response. This treatment is being studied in teenagers and young adults (ages 13–28) whose Crohn's disease continues to flare despite multiple standard medications.
Many patients with Crohn's disease don't achieve long-term control with current medications and face multiple surgeries that can lead to serious complications like short bowel syndrome. This trial exists to see whether a stem cell transplant—which essentially rebuilds the immune system—can provide lasting disease control in people for whom standard treatments have failed.
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If you are accepted into the trial, you will undergo several steps over several months. First, doctors will give you medications to mobilize (move) your stem cells into your bloodstream, then they will collect these cells using a process called leukopheresis. Next, you will receive intensive conditioning treatment to prepare your body, followed by infusion of your collected stem cells back into your body. You will also receive additional medications after the transplant and be monitored closely for safety, including watching for infections and other complications. The trial will track your disease activity, quality of life, and how well you recover over time.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
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