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NCT04399889 · ClinicalTrials.gov registry record · Phase 1
hCT-MSCs for COVID19 ARDS
A Phase 1 study, sponsored by Joanne Kurtzberg, MD.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04399889: Clinical Trial Phase 1 study, sponsored by Joanne Kurtzberg, MD.
NCT04399889 is a Phase 1 study that was terminated before completion, run by Joanne Kurtzberg, MD. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04399889, a Phase 1 study, was terminated before completion, sponsored by Joanne Kurtzberg, MD.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a 50 patient, Phase 1/2a multi-center pilot study to test the safety and to describe the preliminary efficacy of intravenous administration of allogenic human cord tissue mesenchymal stromal cells (hCT-MSC) as an investigational agent, under U.S. INDs 19968 (Duke) and 19937 (U Miami) to patients with acute respiratory distress syndrome (ARDS) due to COVID-19 infection (COVID-ARDS). The first 10 consecutive patients will receive investigational MSCs manufactured by Duke. In the second phase of the study, 40 additional patients will be randomized to receive placebo or investigational MSCs manufactured by Duke or University of Miami. Patients will be eligible for infusion of 3 daily consecutive doses of hCT-MSC or placebo if they have a confirmed diagnosis of COVID-19 and meet clinical and radiographic criteria for ARDS. Results from the first 10 patients will be compared with concurrent outcomes utilizing standard of care treatments in participating hospitals and in published reports in the medical literature. Results from the additional 40 patients will be combined with the first 10 and analyzed. The trial is relying on focused eligibility of the participants (patients with ARDS), single cohort with short trial time (4 weeks), and simple assessment of clinical outcome (survival, improvement of ARDS). This is a sequential design in the sense that after the first 10 patients are evaluated a decision will be made by the PIs and the Data Safety Monitoring Board whether to proceed with the exploratory randomized portion of the study.
Primary Outcome
Number of infusion reactions measured by any one of the following: fever, anaphylaxis, rash, hypertension, hypotension, tachycardia, nausea, vomiting, or any other new or worsening symptoms associated with the infusion.
Interventions
- OTHER Placebo
- BIOLOGICAL Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-06-18 |
| Est. Completion | 2022-02-16 |
| Phase | Phase 1 |
Why NCT04399889 stopped before completion
NCT04399889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04399889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04399889 about?
NCT04399889 is a clinical study titled "hCT-MSCs for COVID19 ARDS". This is a 50 patient, Phase 1/2a multi-center pilot study to test the safety and to describe the preliminary efficacy of intravenous administration of allogenic human cord tissue mesenchymal stromal cells (hCT-MSC) as an investigational agent, under U.S. INDs 19968 (Duke) and 19937 (U Miami) to pati...
What is the current status of trial NCT04399889?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-06-18. Estimated completion is 2022-02-16.
What interventions are being tested in trial NCT04399889?
The interventions under investigation include: Placebo (OTHER), Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University. (BIOLOGICAL).
Who is sponsoring clinical trial NCT04399889?
This trial is sponsored by Joanne Kurtzberg, MD, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04399889's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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