Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease

Exclusion Criteria

• •1. Subject has any alcohol or substance abuse within 6 months of randomization.
• •2. Subject has evidence of fibrostenotic obstructive Crohn's disease.
• •3. Subject has an active infection with HIV or hepatitis B or C.
• •4. Subject has had surgery or trauma within 28 d prior to enrollment.
• •5. Subject has a known allergy to computed tomography (CT) contrast agents.
• •6. Subject has a known allergy to bovine or porcine products.
• •7. Subject has body mass greater than 150 kg.
• •8. Subject has had a stricture of the bowel requiring hospitalization within 6 months prior to enrollment.
• •9. Subject has had bowel surgery other than perianal (for example, fistulotomy, seton placement, or abscess drainage) within 6 months prior to enrollment.
• •10. Subject has received infliximab; adalimumab; or other antibody, protein, or biological therapy not specifically approved by the United States Food and Drug Administration (FDA) for Crohn's disease for 90 days (d) prior to enrollment in study.
• •11. Subject has received prednisone greater than 20 mg/d at any time 28 d prior to enrollment in study.
• •12. Subject has a permanent colostomy or ileostomy.
• •13. Subject has aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine transaminase (ALT) more than 2.5 times the upper limit of normal at screening.
• •14. Subject has evidence of active malignancy other than resected basal or squamous cell carcinoma of the skin, or prior history of active malignancy that has not been in remission for at least 5 years.
• •15. Subject has history of bacteremia or other serious bacterial or fungal infection in past 3 months other than a treated urinary tract infection or drained perianal abscess.
• •16. Subject has received an investigational agent (IA)-an agent or device not approved by FDA for marketed use in any indication-within 90 d (or 5 half-lives, whichever is longer) of randomization.
• •17. Subject has cardiopulmonary disease that, in the opinion of the Investigator, is either unstable or severe enough to justify exclusion from this study.
• •18. Subject has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would make participation in the study unsafe.
• •19. Subject has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject. Such excluding conditions might include, for example, uncontrolled infection, right heart failure, pulmonary hypertension.
• •20. Subject has unstable arrhythmia.
• •21. Subject is unwilling or unable to adhere to requirements of protocols.