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

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.
 
ClinicalTrials.gov Identifier: NCT00482092
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Prochymal® Drug: Placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
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
Actual Study Start Date : September 17, 2007
Actual Primary Completion Date : September 15, 2014
Actual Study Completion Date : September 15, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Participants will receive matching placebo administered as intravenous (IV) infusions.
 Drug: Placebo
Prochymal® Placebo-matching IV infusion
Active Comparator: Prochymal® - Low dose
Participants will receive a total dose of Prochymal® 600 x 10^6 cells, IV infusion, on four days, once daily.
 Drug: Prochymal®
Prochymal® IV infusion
Other Name: Adult Human Mesenchymal Stem Cells
Active Comparator: Prochymal® - High dose
Participants will receive a total dose of Prochymal® 1200 x 10^6 cells, IV infusion, on four days, once daily.
 Drug: Prochymal®
Prochymal® IV infusion
Other Name: Adult Human Mesenchymal Stem Cells


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

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
  • 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)
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Mesoblast, Inc.
Investigators
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Study Director: Mahboob Rahman, MD Mesoblast, Inc.
More Information
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Responsible Party: Mesoblast, Inc.
ClinicalTrials.gov Identifier: NCT00482092    
Obsolete Identifiers: NCT00609232
Other Study ID Numbers: CRD 603
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mesoblast, Ltd. ( Mesoblast, Inc. ):
Crohn's disease
adult stem cell therapy
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Remestemcel-l
Anti-Inflammatory Agents
Antiviral Agents
Anti-Infective Agents