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Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

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ClinicalTrials.gov Identifier: NCT01510431
Recruitment Status : Completed
First Posted : January 16, 2012
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )

Brief Summary:

Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and in the view of the investigator, would not benefit significantly from other Crohn's therapies but would benefit from use of PROCHYMAL.

The study is not placebo-controlled or randomized.


Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: PROCHYMAL (remestemcel-L) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Compassionate Treatment Protocol to Evaluate the Safety and Treatment Outcomes of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease
Study Start Date : May 2009
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PROCHYMAL
Mesenchymal stem cells
Drug: PROCHYMAL (remestemcel-L)
intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter



Primary Outcome Measures :
  1. Crohn's disease activity index (CDAI) [ Time Frame: 1 month ]
    Look for decrease in CDAI at 1 month



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:

  • currently active moderate-to-severe Crohn's disease
  • exhausted standard-of-care options
  • age 18 to 70 inclusive
  • body weight between 30 and 150 kg
  • adequate renal function
  • not at risk for TB activation or re-activation

Exclusion Criteria:

  • biologic therapy for Crohn's within last 8 weeks
  • confirmed adverse reactions during prior PROCHYMAL study participation
  • alcohol or substance abuse, current or within past 6 months
  • active HIV or hepatitis B or C infection
  • surgery or trauma with 6 weeks
  • allergy to bovine or porcine products
  • elevated serum liver enzymes
  • elevated serum bilirubin
  • active malignancy within 5 years (other than some resected skin cancers)
  • bacteremia or other serious bacterial or fungal infection within 3 months
  • colonic dysplasia
  • unstable arrhythmia or serious heart condition

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): NCT01510431


Locations
United States, California
Unviersity of California, San Francisco
San Francisco, California, United States, 94115
United States, Kansas
Stormont-Vail
Topeka, Kansas, United States, 66606
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10128
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2285
Sponsors and Collaborators
Mesoblast International Sàrl
Investigators
Study Director: Donna Skerrett Mesoblast International Sarl

Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT01510431     History of Changes
Other Study ID Numbers: CRD 620
First Posted: January 16, 2012    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

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