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NCT03635450 · ClinicalTrials.gov registry record · Phase 1
Study of hCT-MSC in Newborn Infants With Moderate or Severe HIE
A Phase 1 study, sponsored by Joanne Kurtzberg, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03635450: Completed Phase 1 study, sponsored by Joanne Kurtzberg, MD.
NCT03635450 is a Phase 1 study that has completed, run by Joanne Kurtzberg, MD. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03635450, a Phase 1 study, has completed, sponsored by Joanne Kurtzberg, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
To determine the safety of single and repeated intravenous doses of hCT-MSC in newborn infants with HIE.
Primary Outcome
for this study, infusion reactions are defined as anaphylactic or anaphylactoid reactions with clinical signs inclusive of skin rashes, bronchospasm, angioedema, myocardial infarcts, arrhythmias, and acute lung injury.
Interventions
- BIOLOGICAL Infusion of hCT-MSC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-12-27 |
| Est. Completion | 2020-12-28 |
| Phase | Phase 1 |
What the finished NCT03635450 record still lists
NCT03635450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Infusion of hCT-MSC is the first listed.
NCT03635450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03635450 about?
NCT03635450 is a clinical study titled "Study of hCT-MSC in Newborn Infants With Moderate or Severe HIE". To determine the safety of single and repeated intravenous doses of hCT-MSC in newborn infants with HIE.
What is the current status of trial NCT03635450?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-12-27. Estimated completion is 2020-12-28.
What interventions are being tested in trial NCT03635450?
The interventions under investigation include: Infusion of hCT-MSC (BIOLOGICAL).
Who is sponsoring clinical trial NCT03635450?
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 NCT03635450's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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