Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05035862 · ClinicalTrials.gov registry record · Phase 1
Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma
A Phase 1 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT05035862 is a Phase 1 study that was terminated before completion, run by Emory University. The registered enrollment target is 1 participants.
The verdict
NCT05035862, a Phase 1 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study is a two strata, dose escalation Phase I clinical trial designed to assess the safety and determine the maximal tolerated dose (MTD) of allogenic cord tissue derived MSCs (cMSCs, stratum 1) and allogeneic, interferon-γ primed bone marrow MSCs (γMSCs, stratum 2). Each stratum is designed to independently accrue 3 children at a dose level 1 of 2x106 cells/kg and 6 children at dose level 2 of 10x106 cells/kg, resulting in 9 children in each stratum. The primary objectives are to determine the safety and toxicity of allogeneic cord tissue derived MSCs and allogeneic interferon-γ primed bone marrow derived MSCs.
Interventions
- DRUG Prednisone
- DRUG Albuterol Sulfate
- DRUG Interferon gamma-primed mesenchymal stromal cells (MSCs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2022-03-16 |
| Est. Completion | 2022-12-16 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05035862
The ClinicalTrials.gov registry entry for NCT05035862 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT05035862 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05035862 about?
NCT05035862 is a clinical study titled "Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma". This study is a two strata, dose escalation Phase I clinical trial designed to assess the safety and determine the maximal tolerated dose (MTD) of allogenic cord tissue derived MSCs (cMSCs, stratum 1) and allogeneic, interferon-γ primed bone marrow MSCs (γMSCs, stratum 2). Each stratum is designed t...
What is the current status of trial NCT05035862?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2022-03-16. Estimated completion is 2022-12-16.
What interventions are being tested in trial NCT05035862?
The interventions under investigation include: Prednisone (DRUG), Albuterol Sulfate (DRUG), Interferon gamma-primed mesenchymal stromal cells (MSCs) (DRUG).
Who is sponsoring clinical trial NCT05035862?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.