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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 December 2021 |
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Main ID: |
NCT01233960 |
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Date of registration:
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02/11/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
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Scientific title:
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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 |
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Date of first enrolment:
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November 29, 2010 |
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Target sample size:
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73 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01233960 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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New Zealand
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United States
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Contacts
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Name:
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Mahboob Rahman |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mesoblast, Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: adult human mesenchymal stem cells
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Primary Outcome(s)
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Disease remission
[Time Frame: 180 Days after first infusion in Protocol 603]
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Secondary Outcome(s)
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Improvement in Quality of Life (IBDQ)
[Time Frame: 180 Days after first infusion in Protocol 603]
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Infusional toxicity as a measure of safety and tolerability
[Time Frame: 180 Days after first infusion in Protocol 603]
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Disease Improvement
[Time Frame: 180 Days after first infusion in Protocol 603]
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Number of Adverse events as a measure of safety
[Time Frame: 180 Days after first infusion in Protocol 603]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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