Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01233960|
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : March 10, 2020
|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.
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.|