Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease

Inclusion Criteria:

• failed (within last 2 yr) or intolerant of at least one steroid AND at least oneimmunosuppressant AND at EXACTLY one biologic
• CDAI between 250 and 450, inclusive
• endoscopically or radiographically confirmed Crohn's disease of ileus or colon or both
• C-Reactive Protein Test (CRP) of at least 5 mg/l (0.5 mg/dl)OR CDAI of at least 300
• weight between 40 and 150 kg, inclusive
• adequate renal function
• negative tuberculosis skin (PPD) test (or evaluated low risk of TB activation)

Exclusion Criteria:

• HIV or hepatitis infection active
• allergy to CT contrast agents, or to bovine or porcine products
• symptomatic fibrostenotic Crohn's disease
• permanent ostomy
• biologic therapy within past 90 d
• prednisone greater than 20 mg/d within past month
• short-bowel syndrome
• total parenteral nutrition
• abnormal liver function
• malignancy active within past 5 years (except completely resected basal or squamouscell carcinoma of skin)
• enteric pathogens, including C. difficile
• history of colonic mucosal dysplasia
• current or prior evidence of tuberculosis (TB) (unless risk of activation orre-activation deemed low)