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NCT00763490 · ClinicalTrials.gov registry record · Phase 2
Trial Of Double Umbilical Cord Blood Transplantation
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00763490 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 20 participants.
The verdict
NCT00763490, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This pilot research study is to investigate the safety and effectiveness of stem cell transplantation to treat blood-related (hematopoietic) cancers, using stem cells collected from two different, umbilical cord blood donors. Subjects in this study are receiving a stem cell transplant because other treatments have failed or their disease is unlikely to respond to other treatment options. Blood-related cancers can be treated and sometimes cured with very high doses of chemotherapy and radiation therapy, given to kill the cancer cells; however, these treatments can prove unsuccessful and can harm normal cells in the bone marrow or a patient's disease may be unlikely to respond to these treatment options. Hematopoietic stem cells transplantation (HSCT) is a potential cure, but opportunities to perform HSCT are limited by donor availability. Only 20-30% of patients may have matched family donors. In some cases, a mismatched family donor may be suitable. For patients needing a transplant who do not have a suitably matched family donor, blood stem cells from matched unrelated donors can be used. The length of time required to identify a matched unrelated donor presents another obstacle for patients waiting to receive an HSCT. Blood stem cells are found in umbilical cord blood (UCB), which is blood left over in the placenta (afterbirth) after a baby is born. Usually this blood is discarded with the placenta, but over the past 15 years, we have learned how to collect and freeze cord blood cells to be used for transplants at a later time. A cord blood unit is the cord blood cells collected and stored from a single placenta. More than 6,500 umbilical cord blood stem cell transplants have been done worldwide, mostly in children with leukemia. One important factor affecting the success of a cord blood transplant is the cell dose (number of stem cells in the cord blood unit / recipient's weight). Patients who receive a high cell dose (\> 2.5 x 107 cells/kilogram) have better
Interventions
- DRUG Mycophenolate Mofetil
- PROCEDURE Full intensity, double umbilical cord, stem cell transplant
- DRUG Flu/Bu4 conditioning regimen
- RADIATION Total Lymphoid Irradiation (TLI)
- DRUG Graft versus Host Disease prevention (GVHD prophylaxis)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-12 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00763490
The ClinicalTrials.gov registry entry for NCT00763490 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT00763490 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00763490 about?
NCT00763490 is a clinical study titled "Trial Of Double Umbilical Cord Blood Transplantation". This pilot research study is to investigate the safety and effectiveness of stem cell transplantation to treat blood-related (hematopoietic) cancers, using stem cells collected from two different, umbilical cord blood donors. Subjects in this study are receiving a stem cell transplant because other ...
What is the current status of trial NCT00763490?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2008-12. Estimated completion is 2015-10.
What interventions are being tested in trial NCT00763490?
The interventions under investigation include: Mycophenolate Mofetil (DRUG), Full intensity, double umbilical cord, stem cell transplant (PROCEDURE), Flu/Bu4 conditioning regimen (DRUG), Total Lymphoid Irradiation (TLI) (RADIATION), Graft versus Host Disease prevention (GVHD prophylaxis) (DRUG).
Who is sponsoring clinical trial NCT00763490?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
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