Mesenteric Sparing for the Prevention of Recurrent Crohn's Disease

Stopped early · Not applicable

Conditions studied: Crohn Disease

In brief

The purpose of this study is to determine if taking an increased sampling of mesentery (fatty tissue next to the intestine) and lymph nodes at the time of the subject's ileocolic resection prevents a 4-6 month recurrence of Crohn's disease at the site of the new connection.

Key facts

Study ID

NCT03172143

Run by

Mayo Clinic

People needed

2

Starts

2017-08-29

Expected to finish

2018-12-18

Last updated by the study team

2019-02-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Residents of the United States
• Isolated ileocolic Crohn's disease without evidence of perforation
• Concurrent therapies with corticosteroids, 5-aminosalicylic acid (5-ASA) drugs, thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (TNF) therapy are permitted
• All patients should have undergone a colonoscopy and CT enterography in last 3 months to assess severity of disease
• Have no contraindications to magnetic resonance (MR) evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
• Ability to comply with protocol
• Competent and able to provide written informed consent
• Medically refractory disease or inability to tolerate ongoing medical therapy

You may not qualify if…

• Inability to give informed consent.
• Patients undergoing repeat ileocolic resection
• Patients with concurrent disease in other locations (e.g., proximal stricturing of the small bowel, fistulizing disease to the sigmoid colon) requiring additional operation intervention beyond an ileocolic resection
• Clinically significant medical conditions within the six months before administration of Mesenchymal Stem Cells (MSCs): e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient
• Specific exclusions;
• a. Evidence of hepatitis B, C, or HIV
• History of cancer including melanoma (with the exception of localized skin cancers)
• Emergent indication for an operation
• A resident outside the United States
• Pregnant or breast feeding.
• History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
• Inability to follow up at Mayo Clinic at 3 to 4 and 12 months for postoperative imaging and endoscopy.

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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