NCT01155362Phase 2Completed

PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2012-02Actual

Enrollment · participants50Actual

Source updated2026-07-07Last update listed in the registry record

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Changes to this trial

Last 12 months

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Posted 2026-07-07 · 1 field changed

Main study measure wording changed

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− Before

Measure: 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).~~

+ After

Measure: Percentage of Subjects With Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Both Week 4 and Week 6

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Study details

Conditions studied

Crohn's Disease

Treatments or interventions studied

Human Placenta-Derived Cells PDA001 Intravenous InfusionBiological
Vehicle ControlDrugAlso known as Placebo

Primary outcomes · main study measures

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measure: Percentage of Subjects With Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Both Week 4 and Week 6; description: Clinical response was defined as a reduction from baseline of at least 25% and/or at least 100 points in the Crohn's Disease Activity Index (CDAI) score at both Week 4 (Day 29) and Week 6 (Day 43). The Crohn's Disease Activity Index (CDAI) is a composite clinical index used to assess disease activity in Crohn's disease based on clinical signs, symptoms, and laboratory findings. Scores range from approximately 0 to 600, with higher scores indicating more severe disease activity and lower scores indicating less severe disease activity. Scores of 150 or less generally indicate clinical remission, whereas scores greater than 450 indicate very severe disease activity.; timeFrame: Week 4 (Day 29) and Week 6 (Day 43)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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