Clinical trial NCT01233960: Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Adult Stem Cell Therapy
inflammation of the gastrointestinal tract
Lead sponsor: Mesoblast, Ltd.
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Disease remission
timeFrame: 180 Days after first infusion in Protocol 603
Secondary outcomes:
measure: Disease Improvement
timeFrame: 180 Days after first infusion in Protocol 603
measure: Improvement in Quality of Life (IBDQ)
timeFrame: 180 Days after first infusion in Protocol 603
measure: Number of Adverse events as a measure of safety
timeFrame: 180 Days after first infusion in Protocol 603
measure: Infusional toxicity as a measure of safety and tolerability
timeFrame: 180 Days after first infusion in Protocol 603
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Saint Louis
country: United States
facility: Saint Louis Center for Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Center for Clinical Studies
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth HItchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Germantown
country: United States
facility: Gastroenterology Center of the Midsouth, PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Richmond
country: United States
facility: McGuire Research Institute
state: Virginia
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Christchurch
country: New Zealand
facility: University of Otago
city: Hamilton
country: New Zealand
facility: Waikato Hospital
Study officials:
affiliation: Mesoblast, Inc.
name: Mahboob Rahman
role: STUDY_DIRECTOR
References: