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.
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
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
Crohn's DiseaseAdult Stem Cell Therapyinflammation of the gastrointestinal tract
You can join if…
Open to people ages 18–70
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.
You CAN'T join if...
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.
University of California, San Francisco San Francisco, California, 94115, United States
Cotton-O'Neil Clinical Research Center Topeka, Kansas, 66606, United States
Baylor University Medical Center Dallas, Texas, 75246, United States
Saint Louis Center for Clinical Research St. Louis, Missouri, 63128, United States
St. Louis Center for Clinical Studies St. Louis, Missouri, 63128, United States
Gastroenterology Center of the Midsouth, PC Germantown, Tennessee, 38138, United States
University of Chicago Chicago, Illinois, 60611, United States
Vanderbilt University Medical Center Nashville, Tennessee, 37232, United States
Clinical Research of West Florida Clearwater, Florida, 33765, United States
Shafran Gastroenterology Center Winter Park, Florida, 32789, United States
McGuire Research Institute Richmond, Virginia, 23249, United States
Chevy Chase Clinical Research Chevy Chase, Maryland, 20815, United States
University of Maryland, Baltimore Baltimore, Maryland, 21201, United States
Weill Cornell Medical College New York, New York, 10028, United States
Mount Sinai School of Medicine New York, New York, 10029, United States
Dartmouth HItchcock Medical Center Lebanon, New Hampshire, 03756, United States
University of Otago Christchurch, New Zealand
Waikato Hospital Hamilton, New Zealand
Royal Adelaide Hospital Adelaide, South Australia, Australia
Royal Melbourne Hospital Melbourne, Victoria, Australia