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NCT01769755 · ClinicalTrials.gov registry record · Phase 1
A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease
A Phase 1 study, sponsored by Celularity Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01769755: Completed Phase 1 study, sponsored by Celularity Incorporated.
NCT01769755 is a Phase 1 study that has completed, run by Celularity Incorporated. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01769755, a Phase 1 study, has completed, sponsored by Celularity Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohn's disease who are refractory to one or more standard Crohn's disease therapies.
Primary Outcome
Number of participants experiencing adverse events during the initial and extended follow-up periods
Interventions
- BIOLOGICAL PDA001
- DRUG Vehicle Controlled Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01769755 record still lists
NCT01769755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which PDA001 is the first listed.
NCT01769755 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01769755 about?
NCT01769755 is a clinical study titled "A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease". To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohn's disease who are refractory to one or more standard Crohn's disease therapies.
What is the current status of trial NCT01769755?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2013-03. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01769755?
The interventions under investigation include: PDA001 (BIOLOGICAL), Vehicle Controlled Placebo (DRUG).
Who is sponsoring clinical trial NCT01769755?
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 NCT01769755's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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