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NCT00967525 · ClinicalTrials.gov registry record · NA
Intraosseous Infusion of Unrelated Cord Blood Grafts
A NA study, sponsored by Emory University.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT00967525 is a NA study that was terminated before completion, run by Emory University. The registered enrollment target is 5 participants.
The verdict
NCT00967525, a NA study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
In this trial the investigators seek to determine if injecting cord blood cells directly into the bone marrow (intraosseous injection), rather than infusing them intravenously, can improve engraftment. The rational for doing this is that most hematopoietic stem cells (HSCs) infused intravenously never reach the bone marrow, getting trapped by other organs, such as the lungs, instead. The potential advantage of intraosseous infusion is suggested by studies in rodents that have demonstrated that in HSC transplants where the cell dose is limiting intraosseous injection is a more effective route of administration. The safety of intraosseous injections, in general, is underscored by the vast experience using intraosseous injections for resuscitation of critically ill children. The safety of injecting HSCs intraosseously has been demonstrated in a clinical trial of transplanting bone marrow cells. To safeguard against problems that might result, if intraosseous infusion fails to improve engraftment in this trial, the investigators will integrate a recently introduced strategy proven to improve engraftment-the transplantation of two cord blood units. Transplanting two unrelated cord blood units by intravenous infusion has been shown to improve engraftment (although there is still room for improvement). In this trial one unit will be injected intraosseously and the other unit will be infused intravenously. This study is being conducted as a forerunner to a larger, multi-center trial. The investigators intend to enroll five patients over 1-2 years.
Interventions
- PROCEDURE cord blood infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2007-03 |
| Est. Completion | 2011-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00967525
The ClinicalTrials.gov registry entry for NCT00967525 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which cord blood infusion is the first listed.
NCT00967525 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00967525 about?
NCT00967525 is a clinical study titled "Intraosseous Infusion of Unrelated Cord Blood Grafts". In this trial the investigators seek to determine if injecting cord blood cells directly into the bone marrow (intraosseous injection), rather than infusing them intravenously, can improve engraftment. The rational for doing this is that most hematopoietic stem cells (HSCs) infused intravenously nev...
What is the current status of trial NCT00967525?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2007-03. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00967525?
The interventions under investigation include: cord blood infusion (PROCEDURE).
Who is sponsoring clinical trial NCT00967525?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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