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NCT05027815 · ClinicalTrials.gov registry record · Phase 1
Tregs for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 (regARDS)
A Phase 1 study, sponsored by Jeffrey Bluestone.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT05027815: Clinical Trial Phase 1 study, sponsored by Jeffrey Bluestone.
NCT05027815 is a Phase 1 study that was terminated before completion, run by Jeffrey Bluestone. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05027815, a Phase 1 study, was terminated before completion, sponsored by Jeffrey Bluestone.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
In patients with Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 inflammatory syndrome, the administration of Treg cells is a novel treatment complementary to other pharmacologic interventions that potentially can reduce lung inflammation, promote lung tissue repair, and significantly improve clinical outcomes. This trial is to evaluate the impact of a single IV dose of cePolyTregs given to ARDS patients with COVID-19 inflammatory syndrome.
Primary Outcome
DLT is defined as any related treatment-emergent adverse event (TEAE) with a National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE 5.0) grade ≥ 3 which also represents a shift from baseline clinical status of ≥ 1 NCI CTCAE grade
Interventions
- BIOLOGICAL Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-09-23 |
| Est. Completion | 2022-03-02 |
| Phase | Phase 1 |
Why NCT05027815 stopped before completion
NCT05027815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells is the first listed.
NCT05027815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05027815 about?
NCT05027815 is a clinical study titled "Tregs for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 (regARDS)". In patients with Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 inflammatory syndrome, the administration of Treg cells is a novel treatment complementary to other pharmacologic interventions that potentially can reduce lung inflammation, promote lung tissue repair, and signific...
What is the current status of trial NCT05027815?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2021-09-23. Estimated completion is 2022-03-02.
What interventions are being tested in trial NCT05027815?
The interventions under investigation include: Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT05027815?
This trial is sponsored by Jeffrey Bluestone, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05027815's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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