Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Mesoblast International Sàrl
ClinicalTrials.gov Identifier:
NCT01233960
First Posted: November 3, 2010
Last Update Posted: October 31, 2016
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Crohn's Disease | Drug: adult human mesenchymal stem cells | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
Further study details as provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
Primary Outcome Measures:
- Disease remission [ Time Frame: 180 Days after first infusion in Protocol 603 ]CDAI at or below 150 and increase in IBDQ
Secondary Outcome Measures:
- Disease Improvement [ Time Frame: 180 Days after first infusion in Protocol 603 ]CDAI response to treatments is defined as a CDAI of 150 or below, or a reduction in CDAI of at least 100 points.
- Improvement in Quality of Life (IBDQ) [ Time Frame: 180 Days after first infusion in Protocol 603 ]IBDQ response to treatment is defined as IBDQ of 170 or above, or an increase in IBDQ of at least 16 points.
- 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 ]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.
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | July 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prochymal
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.
|
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.
Other Names:
|
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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233960
Locations
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94115 | |
| United States, Florida | |
| Clinical Research of West Florida | |
| Clearwater, Florida, United States, 33765 | |
| Shafran Gastroenterology Center | |
| Winter Park, Florida, United States, 32789 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kansas | |
| Cotton-O'Neil Clinical Research Center | |
| Topeka, Kansas, United States, 66606 | |
| United States, Maryland | |
| University of Maryland, Baltimore | |
| Baltimore, Maryland, United States, 21201 | |
| Chevy Chase Clinical Research | |
| Chevy Chase, Maryland, United States, 20815 | |
| United States, Missouri | |
| Saint Louis Center for Clinical Research | |
| St. Louis, Missouri, United States, 63128 | |
| St. Louis Center for Clinical Studies | |
| St. Louis, Missouri, United States, 63128 | |
| United States, New Hampshire | |
| Dartmouth HItchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10028 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, Tennessee | |
| Gastroenterology Center of the Midsouth, PC | |
| Germantown, Tennessee, United States, 38138 | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| United States, Virginia | |
| McGuire Research Institute | |
| Richmond, Virginia, United States, 23249 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia | |
| Australia, Victoria | |
| Royal Melbourne Hospital | |
| Melbourne, Victoria, Australia | |
| New Zealand | |
| University of Otago | |
| Christchurch, New Zealand | |
| Waikato Hospital | |
| Hamilton, New Zealand | |
Sponsors and Collaborators
Mesoblast International Sàrl
Investigators
| Study Director: | Pushpam Bharathi | Mesoblast International Sarl |
More Information
| Responsible Party: | Mesoblast International Sàrl |
| ClinicalTrials.gov Identifier: | NCT01233960 History of Changes |
| Other Study ID Numbers: |
CRD 611 |
| First Submitted: | November 2, 2010 |
| First Posted: | November 3, 2010 |
| Last Update Posted: | October 31, 2016 |
| Last Verified: | October 2016 |
Keywords provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
|
Crohn's Disease Adult Stem Cell Therapy inflammation of the gastrointestinal tract |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |