Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

Status:

NO_LONGER_AVAILABLE

Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

Lead Sponsor:

Mesoblast, Inc.

Conditions:

Crohn's Disease

Eligibility:

All Genders

18-70 years

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 anoth...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01510431

Last Update

March 10 2020

Active Locations (4)

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Page 1 of 1 (4 locations)

Unviersity of California, San Francisco

San Francisco, California, United States, 94115

Stormont-Vail

Topeka, Kansas, United States, 66606

Mount Sinai Hospital

New York, New York, United States, 10128