A Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease
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ClinicalTrials.gov Identifier: NCT01155362 |
Recruitment Status
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Completed
First Posted
: July 1, 2010
Last Update Posted
: March 2, 2018
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Sponsor:
Celularity Incorporated
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Celularity Incorporated
Tracking Information | ||||
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First Submitted Date ICMJE | May 26, 2010 | |||
First Posted Date ICMJE | July 1, 2010 | |||
Last Update Posted Date | March 2, 2018 | |||
Study Start Date ICMJE | August 2010 | |||
Actual Primary Completion Date | February 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
A reduction from baseline by 25% and/or > 100 points in the Crohn's Disease Activity Index (CDAI) scores at both Week 4 (Day 29) and at Week 6 (Day 43). [ Time Frame: Week 4 (Day 29) and Week 6 (Day 43) ] Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
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Original Primary Outcome Measures ICMJE |
A reduction from baseline by 25% and/or > 100 points in the Crohn's Disease Activity Index (CDAI) scores at both Week 4 (Day 29) and at Week 6 (Day 43). [ Time Frame: Week 4 (Day 29) and Week 6 (Day 43) ] | |||
Change History | Complete list of historical versions of study NCT01155362 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
The induction of a clinical remission defined as a Crohn's Disease Activity Index score of < 150 points at both Week 4 (Day 29) and Week 6 (Day 43) [ Time Frame: Week 4 (Day 29) and Week 6 (Day 43) ] Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
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Original Secondary Outcome Measures ICMJE |
The induction of a clinical remission defined as a Crohn's Disease Activity Index score of < 150 points at both Week 4 (Day 29) and Week 6 (Day 43) [ Time Frame: Week 4 (Day 29) and Week 6 (Day 43) ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease | |||
Official Title ICMJE | A Phase 2a, Randomized, Double Blind, Placebo Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease | |||
Brief Summary | The primary objective of the study is to estimate the treatment effect of 3 different doses of PDA001 versus placebo in subjects with moderate-to-severe Crohn's Disease. The secondary objective of the study is to assess the safety and tolerability of PDA001 versus placebo in the above-mentioned patient population. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Crohn's Disease | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
50 | |||
Original Estimated Enrollment ICMJE |
52 | |||
Actual Study Completion Date | April 2014 | |||
Actual Primary Completion Date | February 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
A female of childbearing potential is a sexually mature woman who:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01155362 | |||
Other Study ID Numbers ICMJE | CCT-PDA001-002 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Celularity Incorporated | |||
Study Sponsor ICMJE | Celularity Incorporated | |||
Collaborators ICMJE | Celgene Corporation | |||
Investigators ICMJE |
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PRS Account | Celularity Incorporated | |||
Verification Date | July 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |