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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 is a Phase 1 study that was terminated before completion, run by Joanne Kurtzberg, MD. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04399889
The ClinicalTrials.gov registry entry for NCT04399889 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joanne Kurtzberg, MD, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04399889 reports 0 study locations.
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.
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