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NCT04811261 · ClinicalTrials.gov registry record · Early Phase 1
u-STOP LVAD Bleed: Utilization of Umbilical Cord Lining Stem Cells (ULSCs) To Prevent Left Ventricular Assist Device (LVAD) Associated Angiodysplastic Bleeding
A Early Phase 1 study of Angiodysplastic Bleeding, sponsored by University of Florida.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT04811261: Completed Early Phase 1 study of Angiodysplastic Bleeding, sponsored by University of Florida.
NCT04811261 is a Early Phase 1 study of Angiodysplastic Bleeding that has completed, run by University of Florida. The registered enrollment target is 9 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04811261, a Early Phase 1 study of Angiodysplastic Bleeding, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I, single ascending dose, first in human, open-label, non-controlled, dose-escalation trial that will investigate intravenous infusions of Umbilical cord lining stem cells (UCLSCs) in Left Ventricular Assist Device (LVAD) patients. This study will recruit patients from the Advanced Heart Failure and LVAD Clinic at the University of Florida, including recently implanted patients, as well as patients on chronic long-term support, with the goal of enrolling up to 9 subjects to participate in the study.
Primary Outcome
Dose Limiting Toxicities are treatment-emergent suspected adverse reactions graded severe, such as severe infusion-related hypersensitivity toxicities of grade ≥3, and any serious adverse event (SAE). (Note: DLT during an infusion will stop that infusion in that subject.)
Conditions Studied
Interventions
- DRUG Intravenous Infusion of UCLSCs
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2023-07-27 |
| Phase | Early Phase 1 |
What the finished NCT04811261 record still lists
NCT04811261 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 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Angiodysplastic Bleeding appearing as the primary indexed condition, and to 1 intervention - of which Intravenous Infusion of UCLSCs is the first listed.
NCT04811261 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04811261 about?
NCT04811261 is a clinical study titled "u-STOP LVAD Bleed: Utilization of Umbilical Cord Lining Stem Cells (ULSCs) To Prevent Left Ventricular Assist Device (LVAD) Associated Angiodysplastic Bleeding". This is a Phase I, single ascending dose, first in human, open-label, non-controlled, dose-escalation trial that will investigate intravenous infusions of Umbilical cord lining stem cells (UCLSCs) in Left Ventricular Assist Device (LVAD) patients. This study will recruit patients from the Advanced ...
What is the current status of trial NCT04811261?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 9 participants. The study started on 2021-11-01. Estimated completion is 2023-07-27.
What conditions does trial NCT04811261 study?
This clinical trial studies the following conditions: Angiodysplastic Bleeding.
What interventions are being tested in trial NCT04811261?
The interventions under investigation include: Intravenous Infusion of UCLSCs (DRUG).
Who is sponsoring clinical trial NCT04811261?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04811261 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04811261's enrollment target sits among peer trials
9 1746th of 2000 higher than 219 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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