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Eligibility
for people ages 18 years to 70 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

Official Title

A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease

Details

A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.

PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic.

Protocol 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in each of the steroid, immunosuppressant, and biologic classes.

Keywords

Crohn's Disease adult stem cell therapy

Eligibility

You can join if…

Open to people ages 18 years to 70 years

  • 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
  • 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 PPD test (or evaluated low risk of TB activation)

You CAN'T join if...

  • 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 TB (unless risk of activation or re-activation deemed low)

Locations

  • University of Southern California University Hospital
    Los Angeles, California, 90033, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mesoblast International Sàrl
ID
NCT00482092
Phase
Phase 3
Study Type
Interventional
Last Updated
October 2016