Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease

Completed · Phase 3

Conditions studied: Crohn's Disease

In brief

To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.

Key facts

Study ID

NCT01233960

Run by

Mesoblast, Inc.

People needed

73

Starts

2010-11-29

Expected to finish

2014-09-15

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant 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.
• Participant successfully completed all screening assessments in Protocol 603 as required by Protocol 603.
• Participant 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.
• Participant must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603.
• Participant must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.

You may not qualify if…

• Participant is unwilling or unable to adhere to requirements of Protocol 611.
• Participant had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.
• Participant 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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