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



Status:Active, not recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:12/13/2017
Start Date:September 2010
End Date:February 2019

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A Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-severe Crohn's Disease

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 disease therapies.

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 required to be in Protocol 603 during the entire duration of their
participation in Protocol 611, all concomitant medication and safety information will be
monitored by Protocol 603 and the combination of data from the two protocols

Inclusion Criteria:

- Subject must have qualified for, enrolled in, and provided written ICF and
authorization for use and disclosure of 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 Criteria:

- 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.
We found this trial at
17
sites
10012 Kennerly Road
Saint Louis, Missouri 63128
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621 West Lombard Street
Baltimore, Maryland 21201
(410) 706-7101
University of Maryland, Baltimore Welcome to the University of Maryland, Baltimore (UMB) founded in 1807...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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Clearwater, FL
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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701 West Morse Boulevard
Winter Park, Florida 32789
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Winter Park, FL
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Adelaide, South Australia
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Chevy Chase, Maryland 20815
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Germantown, Tennessee 37138
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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New York, New York 10021
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New York, New York 10029
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Richmond, Virginia 23249
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10010 Kennerly Road
Saint Louis, Missouri 63128
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San Francisco, California 94143
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San Francisco, CA
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