Summary

for people ages 18-70 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Details

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

Keywords

Crohn's Disease Adult Stem Cell Therapy inflammation of the gastrointestinal tract Crohn Disease adult human mesenchymal stem cells Prochymal

Eligibility

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.

Locations

  • University of California, San Francisco
    San Francisco California 94115 United States
  • Cotton-O'Neil Clinical Research Center
    Topeka Kansas 66606 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mesoblast International Sàrl
ID
NCT01233960
Phase
Phase 3
Study Type
Interventional
Last Updated