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NCT01310114 · ClinicalTrials.gov registry record · Phase 2
Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Ischemic Stroke
A Phase 2 study, sponsored by Celularity Incorporated.
- Terminated
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT01310114: Clinical Trial Phase 2 study, sponsored by Celularity Incorporated.
NCT01310114 is a Phase 2 study that was terminated before completion, run by Celularity Incorporated. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01310114, a Phase 2 study, was terminated before completion, sponsored by Celularity Incorporated.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
The primary objective of the study is to assess the safety and tolerability of Human Placenta-Derived Cells (PDA001) at 3 different dose levels versus placebo (vehicle control) administered intravenously in subjects following ischemic stroke. The secondary objective of the study is to assess the effect of PDA001 on improvement in clinical function following ischemic stroke.
Primary Outcome
A Treatment-emergent AE was any AE that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. Treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 on the following scale: Grade 1 = mild, Grade 2 = moderate, Gra
Interventions
- DRUG Placebo
- BIOLOGICAL Human Placenta-Derived Cells PDA001- (cenplacel-L)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
Why NCT01310114 stopped before completion
NCT01310114 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01310114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01310114 about?
NCT01310114 is a clinical study titled "Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Ischemic Stroke". The primary objective of the study is to assess the safety and tolerability of Human Placenta-Derived Cells (PDA001) at 3 different dose levels versus placebo (vehicle control) administered intravenously in subjects following ischemic stroke. The secondary objective of the study is to assess the eff...
What is the current status of trial NCT01310114?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2011-03. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01310114?
The interventions under investigation include: Placebo (DRUG), Human Placenta-Derived Cells PDA001- (cenplacel-L) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01310114?
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 NCT01310114's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 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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