ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Active, not recruiting
First Posted : June 4, 2007
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )

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: adult human mesenchymal stem cells 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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : May 2007
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  • 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)

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


  Hide Study Locations
Locations
United States, California
University of Southern California University Hospital
Los Angeles, California, United States, 90033
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Colorado
Western States Clinical Research
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Carle Clinic Association
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, United States, 66606
United States, Kentucky
University of Kentucky Hospital
Lexington, Kentucky, United States, 40536
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Gulf Coast Research
Baton Rouge, Louisiana, United States, 70808
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
National Institutes of Health
Bethesda, Maryland, United States, 20892
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Michigan
Center for Clinical Studies
Dearborn, Michigan, United States, 48124
Center for Digestive Health
Troy, Michigan, United States, 48098
United States, Minnesota
University of Minnesota Hospital
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St Louis Center for Clinical Studies
Saint Louis, Missouri, United States, 63128
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10028
Mount Sinai School of Medicine
New York, New York, United States, 10029
Rochester Institute for Digestive Diseases
Rochester, New York, United States, 14607
Rochester General Hospital
Rochester, New York, United States, 14621
University Hospital and Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, United States, 28207
Pinehurst Medical Clinic
Pinehurst, North Carolina, United States, 28734
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
Gastroenterology United of Tulsa
Tulsa, Oklahoma, United States, 74135
Options Health Research
Tulsa, Oklahoma, United States, 74137
United States, Pennsylvania
Allegheney Center for Digestive Health
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Gastroenterology Center of the Midsouth
Germantown, Tennessee, United States, 37138
Nashville GI Specialists
Nashville, Tennessee, United States, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
University of Texas Medical Branch
Galveston, Texas, United States, 77555
University of Texas Health Science Center
Houston, Texas, United States, 77030
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
McGuire Research Institute
Richmond, Virginia, United States, 23249
United States, Washington
Seattle Gastroenterology Associates
Seattle, Washington, United States, 98133
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8
Canada, Manitoba
Health Science Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
New Zealand
University of Otago
Christchurch, New Zealand
Waikato Hospital
Hamilton, New Zealand
Sponsors and Collaborators
Mesoblast International Sàrl
Investigators
Study Director: Pushpam Bharathi Mesoblast International Sarl

Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT00482092     History of Changes
Obsolete Identifiers: NCT00609232
Other Study ID Numbers: CRD 603
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

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