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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 is a Phase 1 study that has completed, run by Timothy J Nelson, MD, PhD. The registered enrollment target is 30 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01883076
The ClinicalTrials.gov registry entry for NCT01883076 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Timothy J Nelson, MD, PhD, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which autologous cell-based delivery is the first listed.
NCT01883076 reports 0 study locations.
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.
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