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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: Clinical Trial Phase 1 study, sponsored by Emory University.
NCT05035862 is a Phase 1 study that was terminated before completion, run by Emory University. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This outcome will measure safety of allogeneic cord tissue derived MSCs and allogeneic interferon-γ primed bone marrow derived MSCs. Assessments will be made by physical examination and further investigation as indicated. Events will be classified according to the NIH Clinical Toxicity Criteria for Adverse Events (CTCAE), version 5. All recorded adverse events and serious adverse events will be documented and recorded. Their attribution to the γMSC product will be determined. Adverse events that
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 |
Why NCT05035862 stopped before completion
NCT05035862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT05035862 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT05035862's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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