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NCT04494386 · ClinicalTrials.gov registry record · Phase 1
Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS
A Phase 1 study, sponsored by Restem.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT04494386: Completed Phase 1 study, sponsored by Restem.
NCT04494386 is a Phase 1 study that has completed, run by Restem. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04494386, a Phase 1 study, has completed, sponsored by Restem.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (MSC), with intravenous (IV) administration in hospitalized patients with acute respiratory distress syndrome (ARDS) due to COVID-19.
Primary Outcome
Number of subjects with a DLT event during or within 24 hours after ULSC infusion \[Dose Limiting Toxicities are treatment-emergent suspected adverse reactions graded as severe, such as severe infusion-related hypersensitivity toxicities of grade ≥3, and any treatment-emergent serious adverse event (SAE) will be investigated to determine if DLT.\]
Interventions
- BIOLOGICAL Umbilical Cord Lining Stem Cells (ULSC)
- OTHER Placebo (carrier control)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-12-23 |
| Est. Completion | 2023-05-12 |
| Phase | Phase 1 |
What the finished NCT04494386 record still lists
NCT04494386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Umbilical Cord Lining Stem Cells (ULSC) is the first listed.
NCT04494386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04494386 about?
NCT04494386 is a clinical study titled "Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS". ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (M...
What is the current status of trial NCT04494386?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2020-12-23. Estimated completion is 2023-05-12.
What interventions are being tested in trial NCT04494386?
The interventions under investigation include: Umbilical Cord Lining Stem Cells (ULSC) (BIOLOGICAL), Placebo (carrier control) (OTHER).
Who is sponsoring clinical trial NCT04494386?
This trial is sponsored by Restem, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04494386's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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