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NCT03004976 · ClinicalTrials.gov registry record · Phase 2
Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke
A Phase 2 study, sponsored by Joanne Kurtzberg, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
NCT03004976: Completed Phase 2 study, sponsored by Joanne Kurtzberg, MD.
NCT03004976 is a Phase 2 study that has completed, run by Joanne Kurtzberg, MD. The registered enrollment target is 79 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03004976, a Phase 2 study, has completed, sponsored by Joanne Kurtzberg, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the efficacy of a single intravenous infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or myeloablative medications prior to the infusion. Subjects will be followed for one year post infusion for safety and efficacy. Assessments will examine safety and tolerability of the infusion, change in neurological symptoms, change in quality of life, and emotional and cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and 365 days post infusion.
Primary Outcome
The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
Interventions
- OTHER Placebo
- BIOLOGICAL Umbilical Cord Blood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2017-03-14 |
| Est. Completion | 2021-03-27 |
| Phase | Phase 2 |
What the finished NCT03004976 record still lists
NCT03004976 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03004976 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03004976 about?
NCT03004976 is a clinical study titled "Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke". The primary objective of this study is to determine the efficacy of a single intravenous infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB or placebo 3-10 days follo...
What is the current status of trial NCT03004976?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2017-03-14. Estimated completion is 2021-03-27.
What interventions are being tested in trial NCT03004976?
The interventions under investigation include: Placebo (OTHER), Umbilical Cord Blood (BIOLOGICAL).
Who is sponsoring clinical trial NCT03004976?
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 NCT03004976's enrollment target sits among peer trials
79 884th of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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