Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT01233960|
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : December 8, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: adult human mesenchymal stem cells||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 29, 2010|
|Actual Primary Completion Date :||September 15, 2014|
|Actual Study Completion Date :||September 15, 2014|
Infusions of Prochymal 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.
- Disease remission [ Time Frame: 180 Days after first infusion in Protocol 603 ]Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ
- 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.
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|Study Director:||Mahboob Rahman||Mesoblast, Inc.|
|Responsible Party:||Mesoblast, Inc.|
|Other Study ID Numbers:||
|First Posted:||November 3, 2010 Key Record Dates|
|Last Update Posted:||December 8, 2021|
|Last Verified:||March 2020|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Adult Stem Cell Therapy
inflammation of the gastrointestinal tract
Inflammatory Bowel Diseases
Digestive System Diseases