Overview

This trial is active, not recruiting.

Condition crohn's disease
Treatment adult human mesenchymal stem cells
Phase phase 3
Sponsor Mesoblast International Sàrl
Start date September 2010
End date July 2017
Trial size 120 participants
Trial identifier NCT01233960, CRD 611

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Infusions of Prochyaml on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells.
adult human mesenchymal stem cells 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.

Primary Outcomes

Measure
Disease remission
time frame: 180 Days after first infusion in Protocol 603

Secondary Outcomes

Measure
Disease Improvement
time frame: 180 Days after first infusion in Protocol 603
Improvement in Quality of Life (IBDQ)
time frame: 180 Days after first infusion in Protocol 603
Number of Adverse events as a measure of safety
time frame: 180 Days after first infusion in Protocol 603
Infusional toxicity as a measure of safety and tolerability
time frame: 180 Days after first infusion in Protocol 603

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Additional Information

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
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Mesoblast, Ltd..