Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT01510431
- Lead Sponsor
- Mesoblast, Inc.
- Brief Summary
Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and in the view of the investigator, would not benefit significantly from other Crohn's therapies but would benefit from use of PROCHYMAL.
The study is not placebo-controlled or randomized.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- currently active moderate-to-severe Crohn's disease
- exhausted standard-of-care options
- age 18 to 70 inclusive
- body weight between 30 and 150 kg
- adequate renal function
- not at risk for tuberculosis (TB) activation or re-activation
Exclusion Criteria
- biologic therapy for Crohn's within last 8 weeks
- confirmed adverse reactions during prior PROCHYMAL study participation
- alcohol or substance abuse, current or within past 6 months
- active HIV or hepatitis B or C infection
- surgery or trauma with 6 weeks
- allergy to bovine or porcine products
- elevated serum liver enzymes
- elevated serum bilirubin
- active malignancy within 5 years (other than some resected skin cancers)
- bacteremia or other serious bacterial or fungal infection within 3 months
- colonic dysplasia
- unstable arrhythmia or serious heart condition
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Unviersity of California, San Francisco
🇺🇸San Francisco, California, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Stormont-Vail
🇺🇸Topeka, Kansas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States