The presence of any of the following will exclude a subject from enrollment:
1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he or she were to participate in the study.
3. Any condition that confounds the ability to interpret data from the study.
4. Pregnant or lactating females.
5. Morbidly obese subjects (subjects with a BMI > 35 at screening).
6. AST or ALT > 2.5 x the upper limit of normal at screening.
7. Serum creatinine concentration > 2.0 mg/dl at screening.
8. Alkaline phosphatase > 2.5 x the upper limit of normal at screening.
9. Bilirubin level > 2 mg/dL (unless subject has known Gilbert’s disease).
10. Untreated chronic infection or treatment of any infection with antibiotics within 4 weeks prior to dosing with IP (other than a treated urinary tract infection or drained perianal abscess). Note: Stable doses of antibiotics used to treat CD are allowed.
11. Organic heart disease (eg, congestive heart failure) or clinically significant abnormal findings on ECG.
12. Clinically significant arrhythmia.
13. Documented prior history of neurological disease or evidence of ongoing neurological disease.
14. History of other malignancies within 5 years (except basal cell carcinoma of the skin that is surgically cured, remote history of cancer now considered cured or positive Pap smear with subsequent negative follow up).
15. Subject has had a stricture of the bowel requiring hospitalization within 182 days (6 months) prior to treatment with IP.
16. Subject has had bowel surgery other than perianal (for example, fistulotomy, seton placement, or abscess drainage) or previous abscess drainage within 182 days (6 months) prior to treatment with IP.
17. Subject tests positive for Clostridium difficile toxin at screening.
18. Any surgery within 28 days prior to treatment with IP.
19. Subject has a colostomy, ileostomy or ileal pouch anal anastomosis.
20. Subject has received an investigational agent —an agent or device not approved by FDA for marketed use in any indication—within 90 days (or 5 half-lives, whichever is longer) prior to treatment with IP.
21. Subject has received previous cell therapy.
22. Subject is expecting to have elective surgery at any time between Visit 1 (screening) and Visit 7 (end of induction phase).
23. Subject has a concurrent diagnosis of ulcerative colitis.
24. Subject has a known hypersensitivity to bovine or porcine products.
25. Subject has a known hypersensitivity to hydrocortisone and/or diphenhydramine (Benadryl®) and/or enoxaparin sodium (Lovenox®) and/or heparin.
26. Subjects with known history of heparin-induced thrombocytopenia.
27. Subjects with protein C or S deficiency.
28. Subjects with prior history of thrombophlebitis or other pathological arterial or venous thrombosis.