Inflammatory Bowel Disease

Stem cell therapy for inflammatory bowel disease is being studied because cell-based approaches may influence inflammation and immune signaling in people with ulcerative colitis or Crohn’s disease. Researchers are evaluating different cell sources, doses, delivery methods, disease types, and treatment goals. Research on stem cell therapy for Crohn’s disease and ulcerative colitis involves distinct treatment settings and outcomes.

What Researchers Are Studying

• Influence inflammatory and immune-system signaling
• Be delivered safely and feasibly in carefully selected patients
• Be further evaluated for their effects on symptoms, disease activity, and fistula healing
• Help identify which products and treatment approaches warrant additional research

Some studies examine intravenous cell infusions for ulcerative colitis or Crohn’s disease. Others evaluate locally delivered cell products for a specific complication, such as complex perianal fistulas in Crohn’s disease.

Note: Stem cell therapies for inflammatory bowel disease are not FDA-approved and are investigational. Research findings do not guarantee individual results.

How Stem Cell Therapy for IBD Is Being Studied

Mesenchymal stromal cell, or MSC, approaches are being studied because they may affect immune signaling and inflammation. Researchers are evaluating intravenous infusions for luminal disease and local injection procedures for complex perianal Crohn’s fistulas. Studies are examining symptoms, disease-activity scores, laboratory markers, and fistula healing. This work is helping researchers better understand which products, delivery methods, and patient groups warrant continued clinical study. Stem cell treatment for ulcerative colitis remains investigational.

2026: Darvadstrocel Was Studied for Complex Perianal Crohn’s Fistulas

Darvadstrocel in Patients With Crohn’s Disease With Complex Perianal Fistulas: The ADMIRE CD II Phase 3 Randomized Trial — Read Study

This phase III randomized, double-blind, placebo-controlled study evaluated darvadstrocel, a locally injected product made from expanded fat-tissue-derived MSCs, for complex perianal fistulas in Crohn’s disease. The study included 568 participants. At 24 weeks, combined remission occurred in 48.8% of participants receiving darvadstrocel and 46.3% receiving placebo. The study also evaluated additional fistula-healing outcomes and safety measures. These findings add phase III clinical data on local MSC-based treatment for complex perianal Crohn’s fistulas.

2024: UC-MSCs Reported Early Safety and Clinical Findings in Ulcerative Colitis

Safety and Potential Efficacy of Expanded Umbilical Cord-Derived Mesenchymal Stromal Cells in Luminal Ulcerative Colitis Patients — Read Study

This prospective phase I pilot study enrolled six people with luminal ulcerative colitis. Participants received three intravenous injections of 100 million expanded umbilical-cord-derived MSCs, given two weeks apart. The researchers reported safety findings and potential clinical signals during follow-up. These results provide early clinical information on intravenous UC-MSC treatment for people with ulcerative colitis.

2016: Adipose-Derived MSCs Reported Higher Fistula Remission Rates

Expanded Allogeneic Adipose-Derived Mesenchymal Stem Cells (Cx601) for Complex Perianal Fistulas in Crohn’s Disease: A Phase 3 Randomised, Double-Blind Controlled Trial — Read Study

This randomized trial enrolled 212 adults with treatment-refractory complex perianal Crohn’s fistulas. It evaluated Cx601, the development code for darvadstrocel, a locally injected adipose-derived MSC product. At 24 weeks, combined remission occurred in 49.5% of participants in the Cx601 group and 34.3% in the control group. These results support continued research on locally injected MSC products for Crohn’s-related fistulas.

For people living with IBD, stem cell therapy for IBD and other regenerative medicine approaches may be topics to discuss with a healthcare provider. A consultation can help review your diagnosis, disease activity, medications, prior treatment response, imaging or endoscopy findings, and goals. Useful questions include:

• What type of IBD or complication is being treated?
• What specific product and delivery method are being considered?
• Is the evidence from a controlled study, and does it apply to my condition?
• What established treatment options should also be considered?
• What risks, follow-up, and outcome measures are involved?

At Stemedix, we take a patient-centered approach to regenerative medicine, informed by emerging clinical research. Our team reviews your medical history, current treatment plan, and goals to help determine whether an investigational regenerative approach may be appropriate to explore.

This page is for educational purposes only and does not constitute medical advice.
Stem cell and regenerative medicine therapies for inflammatory bowel disease are investigational and are not FDA-approved for this use. Research findings do not guarantee individual results.
Always consult a qualified healthcare professional before making treatment decisions.

1. Colombel JF. et al. Darvadstrocel in Patients With Crohn’s Disease With Complex Perianal Fistulas: The ADMIRE CD II Phase III Randomized Trial. Gastroenterology., 2026. PubMed
2. Jafar H. et al. Safety and Potential Efficacy of Expanded Umbilical Cord-Derived Mesenchymal Stromal Cells in Luminal Ulcerative Colitis Patients. Stem Cells and Development., 2024. PubMed
3. Panés J. et al. Expanded Allogeneic Adipose-Derived Mesenchymal Stem Cells (Cx601) for Complex Perianal Fistulas in Crohn’s Disease: A Phase III Randomised, Double-Blind Controlled Trial. The Lancet., 2016. PubMed

U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. FDA