Overview

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

Status:
Completed
Trial end date:
2014-09-15
Target enrollment:
0
Participant gender:
All
Summary
Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mesoblast International Sàrl
Mesoblast, Inc.
Treatments:
Remestemcel-l
Criteria
Inclusion Criteria:

- failed (within last 2 yr) or intolerant of at least one steroid AND at least one
immunosuppressant 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 squamous
cell carcinoma of skin)

- enteric pathogens, including C. difficile

- history of colonic mucosal dysplasia

- current or prior evidence of tuberculosis (TB) (unless risk of activation or
re-activation deemed low)