A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease

Inclusion Criteria:

• Males and females 18 - 75 years of age at the time of signing the informed consent document.
• Minimum weight of subject is 50 kg at screening.
• Subject must have inflammatory Crohn's Disease (CD) with colonic involvement diagnosed at least 6 months but no greater than 5 years prior to treatment with Investigational Product (IP).
• Subject must have confirmation of ongoing CD with colonic involvement activity by ileocolonoscopy at screening. Note: CD in other areas of the Gastrointestinal tract (GI) is acceptable.
• Subject must have a Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450 as assessed between Visit 1 and Visit 2.
• Subject has Crohn's Disease Endoscopic Index of Severity (CDEIS) score ≥ 8.
• In the judgment of the investigator, the subject must have had an inadequate response or lost response (recurrence of symptoms) to a Crohn's disease agent at any time prior to enrollment.

Exclusion Criteria:

• Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study including but not limited to.

  • Liver Function Tests Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 2.5 x the upper limit of normal at screening.
  • Serum creatinine concentration > 2.0 mg/dl at screening. Alkaline phosphatase > 2.5 x the upper limit of normal at screening.
  • Bilirubin level > 2 mg/dL (unless subject has known Gilbert's disease).
• Pregnant or lactating females.
• Morbidly obese subjects Body Mass Index (BMI) > 35 at screening).
• Subject has untreated chronic infection including Clostridium difficile toxin positive at screening 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 Crohn's Disease are allowed.
• Subject has organic heart disease (eg, congestive heart failure), clinically significant arrhythmia or clinically significant abnormal findings on Electrocardiograms (ECG).
• Subject has a 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).
• Subject has had a stricture of the bowel requiring hospitalization within 182 days prior to treatment with IP.
• Subject has had bowel surgery other than perianal (for example, fistulotomy, seton placement, or abscess drainage) or previous abscess drainage within 182 days prior to treatment with IP.
• Subject has had any surgery within 28 days prior to treatment with IP.
• Subject has a colostomy, ileostomy or ileal pouch anal anastomosis.
• 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 investigational product.
• Subject has received previous cell therapy.
• Subject is expecting to have elective surgery within 12 weeks prior to dosing with IP.
• Subject has concurrent diagnosis of ulcerative colitis.
• Subjects with protein C or S deficiency.
• Subjects with prior history of thrombophlebitis or other pathological arterial or venous thrombosis.