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NCT02013700 · ClinicalTrials.gov registry record · Phase 1
Allogeneic Human Cells (hMSC)in Patients With Idiopathic Pulmonary Fibrosis Via Intravenous Delivery (AETHER)
A Phase 1 study, sponsored by Joshua M Hare.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT02013700: Clinical Trial Phase 1 study, sponsored by Joshua M Hare.
NCT02013700 is a Phase 1 study that was terminated before completion, run by Joshua M Hare. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02013700, a Phase 1 study, was terminated before completion, sponsored by Joshua M Hare.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a phase I, randomized, blinded, placebo-controlled 9 subjects pilot safety run-in followed by an additional 16 randomized subjects for a total of 25 subjects. In the pilot phase subjects will be randomized into three treatment groups of allogenic mesenchymal stem cells and in the randomized phase subjects will receive either allogenic mesenchymal stem cells or matched placebo.
Primary Outcome
Safety (Primary): Incidence (one month post infusion) of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
Interventions
- BIOLOGICAL Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs)
- BIOLOGICAL matched placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-11-13 |
| Est. Completion | 2016-11-24 |
| Phase | Phase 1 |
Why NCT02013700 stopped before completion
NCT02013700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs) is the first listed.
NCT02013700 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02013700 about?
NCT02013700 is a clinical study titled "Allogeneic Human Cells (hMSC)in Patients With Idiopathic Pulmonary Fibrosis Via Intravenous Delivery (AETHER)". This is a phase I, randomized, blinded, placebo-controlled 9 subjects pilot safety run-in followed by an additional 16 randomized subjects for a total of 25 subjects. In the pilot phase subjects will be randomized into three treatment groups of allogenic mesenchymal stem cells and in the randomized ...
What is the current status of trial NCT02013700?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2013-11-13. Estimated completion is 2016-11-24.
What interventions are being tested in trial NCT02013700?
The interventions under investigation include: Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs) (BIOLOGICAL), matched placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT02013700?
This trial is sponsored by Joshua M Hare, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02013700's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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