Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
NCT ID: NCT01233960
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
73 participants
INTERVENTIONAL
2010-11-29
2014-09-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prochymal
Infusions of Prochymal on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells.
adult human mesenchymal stem cells
PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603.
Interventions
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adult human mesenchymal stem cells
PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject successfully completed all screening assessments in Protocol 603 as required by Protocol 603.
* Subject successfully completed the full course of each of the four infusions of investigational agent on Days 0, 3, 7, and 14 of Protocol 603 after August 3, 2010.
* Subject must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603.
* Subject must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.
Exclusion Criteria
* Subject had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.
* Subject had a serious adverse event in any previous PROCHYMAL study that was deemed by the principal investigator of that study to be possibly or probably related to PROCHYMAL and also that was within 48 h after a PROCHYMAL infusion.
18 Years
70 Years
ALL
No
Sponsors
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Mesoblast, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mahboob Rahman
Role: STUDY_DIRECTOR
Mesoblast, Inc.
Locations
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University of California, San Francisco
San Francisco, California, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
University of Chicago
Chicago, Illinois, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Saint Louis Center for Clinical Research
St Louis, Missouri, United States
St. Louis Center for Clinical Studies
St Louis, Missouri, United States
Dartmouth HItchcock Medical Center
Lebanon, New Hampshire, United States
Weill Cornell Medical College
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Gastroenterology Center of the Midsouth, PC
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
McGuire Research Institute
Richmond, Virginia, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
University of Otago
Christchurch, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Countries
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Other Identifiers
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CRD 611
Identifier Type: -
Identifier Source: org_study_id