Mesenteric Sparing for the Prevention of Recurrent Crohn's Disease

Crohn's disease (CD) is a chronic inflammatory disease of the intestinal tract with an
unknown etiology and an unknown cure. The characteristic transmural inflammation can progress
to refractory inflammatory disease, stricturing disease, and fistulizing disease - all
potential indications for surgery when medical management has been exhausted. An important
tenant to remember is that surgery is not curative but is rather an adjunct to maximal
medical therapy.

One third of patients with CD will require a major abdominal resection within 5 years of
their diagnosis, and two-thirds will ultimately require operative management at least once
during the course of their disease. Unfortunately, surgery for CD is not curative and disease
recurrence is common with 62% having endoscopic recurrence at six months, and 80% and 30% of
patients having endoscopic and clinical recurrence, respectively, at one year. A third of
these patients will require a re-operation at 10 years and up to 80% will require an
additional operation by 15 years. This undoubtedly leads to an increased probability of
malabsorption syndrome and decreased quality of life.

A significant volume of research has been conducted in attempt to determine how to prevent
postoperative recurrence of CD following an ileocolic resection. Some studies have focused on
the timing of resuming postoperative medical therapy. Others have looked at surgical
technique at the time of ileocolic resection including anatomic configuration of the
anastomosis and performing a stapled versus handsewn anastomosis.

There is recent evidence to suggest that the mesentery is actively involved in the ongoing
disease process. The investigators plan to investigate if taking additional mesentery affects
postoperative recurrence to support these findings.

Inclusion Criteria:

1. Residents of the United States

2. Isolated ileocolic Crohn's disease without evidence of perforation

3. Concurrent therapies with corticosteroids, 5-aminosalicylic acid (5-ASA) drugs,
thiopurines, methotrexate (MTX), antibiotics, and anti-tumor necrosis factor (TNF)
therapy are permitted

4. All patients should have undergone a colonoscopy and CT enterography in last 3 months
to assess severity of disease

5. Have no contraindications to magnetic resonance (MR) evaluations: e.g. pacemaker or
magnetically active metal fragments, claustrophobia

6. Ability to comply with protocol

7. Competent and able to provide written informed consent

8. Medically refractory disease or inability to tolerate ongoing medical therapy

Exclusion Criteria:

1. Inability to give informed consent.

2. Patients undergoing repeat ileocolic resection

3. 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

4. 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

5. Specific exclusions;

a. Evidence of hepatitis B, C, or HIV

6. History of cancer including melanoma (with the exception of localized skin cancers)

7. Emergent indication for an operation

8. A resident outside the United States

9. Pregnant or breast feeding.

10. History of clinically significant auto-immunity (other than Crohn's disease) or any
previous example of fat-directed autoimmunity

11. Inability to follow up at Mayo Clinic at 3 to 4 and 12 months for postoperative
imaging and endoscopy.