NCT01233960

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Mesoblast, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.

Detailed description

Participants 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 participants 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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Prochymal®	PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603.

Timeline

• Start date: 2010-11-29
• Primary completion: 2014-09-15
• Completion: 2014-09-15
• First posted: 2010-11-03
• Last updated: 2026-03-11

Locations

20 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study