Crohn’s Disease

Crohn’s disease is a chronic form of inflammatory bowel disease, or IBD. It can affect any part of the digestive tract, from the mouth to the anus, and inflammation may extend through the full thickness of the bowel wall. The condition often affects the small intestine and colon. Symptoms and complications vary based on where inflammation occurs, how active it is, and whether it has caused changes such as narrowing of the bowel, abscesses, or fistulas.

Common Symptoms

Complications can include fistulas, abscesses, or bowel narrowing in more complex cases. Crohn’s disease often follows a pattern of flares and periods of remission. New or worsening symptoms should be discussed with a gastroenterology clinician, particularly when there is severe pain, fever, vomiting, rectal bleeding, or difficulty passing stool or gas.

Treatment is individualized based on disease location, severity, complications, prior treatment response, and overall health. The goals are to control inflammation, reduce symptoms, prevent complications, and protect long-term bowel function.

Standard Treatment Categories

• Anti-inflammatory and immune-modifying medicines: Treatment may include corticosteroids for short-term flare control, immunomodulators, biologic medicines, or oral small-molecule therapies.
• Nutrition and supportive care: Nutrition assessment, treatment of vitamin or mineral deficiencies, smoking cessation, and support for fatigue or mental health can be important parts of care.
• Monitoring: Blood tests, stool testing, imaging, and endoscopy can help clinicians assess inflammation and treatment response.
• Treatment for complications: Antibiotics, drainage procedures, or surgery may be needed for abscesses, fistulas, bowel obstruction, or other complications.
• Surgery: Surgery may be considered when disease complications or persistent symptoms do not respond adequately to medical treatment.

Stem cell therapy for Crohn’s disease is being studied because cell-based approaches may influence inflammation and immune signaling. Research includes locally injected cell products for complex perianal fistulas and systemic cell infusions for luminal Crohn’s disease, meaning inflammation inside the intestine.

What Researchers Are Studying

• Be delivered safely and feasibly in carefully selected patients
• Be further evaluated for their effects on complex perianal fistula healing
• Influence symptoms and disease activity in luminal Crohn’s disease
• Help identify which cell products, delivery methods, and patient groups warrant additional research

The most developed research focuses on complex perianal fistulas, abnormal tunnels that can form near the anus. This is distinct from research on inflammation throughout the digestive tract.

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

How Stem Cell Therapy for Crohn’s Disease Is Being Studied

Mesenchymal stromal cell, or MSC, approaches are being studied because they may influence immune signaling and inflammation. In Crohn’s disease, researchers have examined locally delivered products for fistulas and intravenous approaches for selected people with active intestinal disease. Studies are tracking fistula closure, symptoms, disease-activity measures, and safety outcomes. This work is helping identify which cell products, delivery methods, and patient groups warrant continued clinical study. Stem cell treatment for Crohn’s disease 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, the same cell therapy previously studied as Cx601, in 568 people with complex perianal Crohn’s fistulas. At 24 weeks, combined remission occurred in 48.8% of participants receiving darvadstrocel and 46.3% receiving placebo. These findings add phase III clinical data on locally injected MSC therapy for complex perianal Crohn’s fistulas.

2024: Umbrella Review Reported Clinical Remission and Fistula-Closure Findings

Safety and Efficacy of Stem Cell Therapy for Crohn’s Disease: An Umbrella Review of Systematic Reviews — Read Study

This umbrella review combined findings from 16 prior systematic reviews of stem cell research in Crohn’s disease. The authors reported pooled findings for clinical remission and fistula closure across the included studies, also evaluating Crohn’s Disease Activity Index and Perianal Disease Activity Index outcomes. These findings add to the growing body of clinical research on cell-based approaches for people with Crohn’s disease.

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 adipose-derived MSC products for Crohn’s-related fistulas.