Status:
COMPLETED
Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
Lead Sponsor:
Mesoblast, Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol 603 to evaluate the safety in subjects with active Crohn's disease who are resistant to standard Crohn's di...
Detailed Description
Subjects will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells. As subjects will be requi...
Eligibility Criteria
Inclusion
- Subject must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010.
- 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
- Subject is unwilling or unable to adhere to requirements of Protocol 611.
- 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.
Key Trial Info
Start Date :
November 29 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2014
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01233960
Start Date
November 29 2010
End Date
September 15 2014
Last Update
December 8 2021
Active Locations (20)
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1
University of California, San Francisco
San Francisco, California, United States, 94115
2
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
3
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
4
University of Chicago
Chicago, Illinois, United States, 60611