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NCT01883076 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome
A Phase 1 study, sponsored by Timothy J Nelson, MD, PhD.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01883076: Completed Phase 1 study, sponsored by Timothy J Nelson, MD, PhD.
NCT01883076 is a Phase 1 study that has completed, run by Timothy J Nelson, MD, PhD. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01883076, a Phase 1 study, has completed, sponsored by Timothy J Nelson, MD, PhD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a Phase I study to determine the safety and feasibility of injections of autologous umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome (HLHS) children undergoing a scheduled Glenn surgical procedure. The investigators are doing this research study to find out if autologous stem cells from the individual's own umbilical cord blood can be used to strengthen the muscle of the right side of their heart. This will help determine the safety and feasibility of using cell-based regenerative therapy as an additional treatment for the management of HLHS.
Interventions
- BIOLOGICAL autologous cell-based delivery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-05-15 |
| Est. Completion | 2021-04-28 |
| Phase | Phase 1 |
What the finished NCT01883076 record still lists
NCT01883076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which autologous cell-based delivery is the first listed.
NCT01883076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01883076 about?
NCT01883076 is a clinical study titled "Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome". This is a Phase I study to determine the safety and feasibility of injections of autologous umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome (HLHS) children undergoing a scheduled Glenn surgical procedure. The investigators are doing this research study t...
What is the current status of trial NCT01883076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-05-15. Estimated completion is 2021-04-28.
What interventions are being tested in trial NCT01883076?
The interventions under investigation include: autologous cell-based delivery (BIOLOGICAL).
Who is sponsoring clinical trial NCT01883076?
This trial is sponsored by Timothy J Nelson, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01883076's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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