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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482092
First Posted: June 4, 2007
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
  Purpose
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.

Condition Intervention Phase
Crohn's Disease Drug: adult human mesenchymal stem cells Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):

Primary Outcome Measures:
  • Disease remission (CDAI at or below 150) [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Disease improvement (Reduction by at least 100 points in CDAI) [ Time Frame: 28 days ]
  • Improvement in quality of life (IBDQ) [ Time Frame: 28 days ]
  • Reduction in number of draining fistulas [ Time Frame: 28 days ]

Estimated Enrollment: 330
Study Start Date: May 2007
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Placebo
Placebo
Active Comparator: 2
Low dose (600 million cells total over four infusions in two weeks)
Drug: adult human mesenchymal stem cells
Intravenous infusion of suspension of adult human mesenchymal stem cells, total of 1200 million (high dose) or 600 million (low dose) cells infused in four visits over two weeks.
Active Comparator: 3
High dose (1200 million cells delivered in four infusions over two weeks)
Drug: adult human mesenchymal stem cells
Intravenous infusion of suspension of adult human mesenchymal stem cells, total of 1200 million (high dose) or 600 million (low dose) cells infused in four visits over two weeks.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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)

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 TB (unless risk of activation or re-activation deemed low)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482092


  Show 56 Study Locations
Sponsors and Collaborators
Mesoblast International Sàrl
Investigators
Study Director: Pushpam Bharathi Mesoblast International Sarl
  More Information

Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT00482092     History of Changes
Obsolete Identifiers: NCT00609232
Other Study ID Numbers: CRD 603
First Submitted: May 30, 2007
First Posted: June 4, 2007
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
Crohn's disease
adult stem cell therapy

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases