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NCT01155362 · ClinicalTrials.gov registry record · Phase 2
PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease
A Phase 2 study, sponsored by Celularity Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01155362: Completed Phase 2 study, sponsored by Celularity Incorporated.
NCT01155362 is a Phase 2 study that has completed, run by Celularity Incorporated. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01155362, a Phase 2 study, has completed, sponsored by Celularity Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
This Phase 2a study evaluated the efficacy, safety, and tolerability of intravenous human placenta-derived cells (PDA001) compared with placebo in adults with moderate-to-severe Crohn's disease. Three PDA001 dose levels were evaluated.
Primary Outcome
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 i
Interventions
- DRUG Vehicle Control
- BIOLOGICAL Human Placenta-Derived Cells PDA001 Intravenous Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT01155362 record still lists
NCT01155362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle Control is the first listed.
NCT01155362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01155362 about?
NCT01155362 is a clinical study titled "PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease". This Phase 2a study evaluated the efficacy, safety, and tolerability of intravenous human placenta-derived cells (PDA001) compared with placebo in adults with moderate-to-severe Crohn's disease. Three PDA001 dose levels were evaluated.
What is the current status of trial NCT01155362?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2010-08. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01155362?
The interventions under investigation include: Vehicle Control (DRUG), Human Placenta-Derived Cells PDA001 Intravenous Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT01155362?
This trial is sponsored by Celularity Incorporated, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01155362's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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