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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233960
• Other study ID #: CRD 611
• Status: Completed
• Phase: Phase 3
• Start date: November 29, 2010
• Est. completion date: September 15, 2014

Study information

• Verified date: March 2020
• Source: Mesoblast, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 15, 2014
• Est. primary completion date: September 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subject must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• adult human mesenchymal stem cells
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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Melbourne Hospital	Melbourne	Victoria
New Zealand	University of Otago	Christchurch
New Zealand	Waikato Hospital	Hamilton
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	University of Chicago	Chicago	Illinois
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Baylor University Medical Center	Dallas	Texas
United States	Gastroenterology Center of the Midsouth, PC	Germantown	Tennessee
United States	Dartmouth HItchcock Medical Center	Lebanon	New Hampshire
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai School of Medicine	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	McGuire Research Institute	Richmond	Virginia
United States	Saint Louis Center for Clinical Research	Saint Louis	Missouri
United States	St. Louis Center for Clinical Studies	Saint Louis	Missouri
United States	University of California, San Francisco	San Francisco	California
United States	Cotton-O'Neil Clinical Research Center	Topeka	Kansas
United States	Shafran Gastroenterology Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mesoblast, Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease remission	Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ	180 Days after first infusion in Protocol 603
Secondary	Disease Improvement	CDAI response to treatments is defined as a CDAI of 150 or below, or a reduction in CDAI of at least 100 points.	180 Days after first infusion in Protocol 603
Secondary	Improvement in Quality of Life (IBDQ)	IBDQ response to treatment is defined as IBDQ of 170 or above, or an increase in IBDQ of at least 16 points.	180 Days after first infusion in Protocol 603
Secondary	Number of Adverse events as a measure of safety		180 Days after first infusion in Protocol 603
Secondary	Infusional toxicity as a measure of safety and tolerability	Infusional toxicity will be evaluated by continuously monitoring the subject's vital signs and O2 saturation by pulse oximetry from the time of PROCHYMAL administration until two hours after infusion is complete.	180 Days after first infusion in Protocol 603