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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 3, 2007 | ||||||||
| Last Updated Date | March 3, 2008 | ||||||||
| Start Date ICMJE | August 2005 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00511550 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors | ||||||||
| Official Title ICMJE | Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors | ||||||||
| Brief Summary | Peripheral blood stem cells (PBSCs) collected following stimulation with filgrastim are commonly used for autologous hematopoietic transplants. PBSCs are also now being used for some syngeneic and allogeneic hematopoietic transplants involving HLA-matched sibling donors. However, many issues remain unanswered about the use of PBSCs for allogeneic transplants and the effects of filgrastim on healthy individuals. The purpose of this study is to determine the effectiveness of filgrastim stimulated PBSCs in hematopoietic cell transplants involving unrelated donors and to determine the effects of this donation process on unrelated stem cell donors. |
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| Detailed Description | This study establishes and evaluates a system to supply peripheral blood stem cell (PBSC)products for use in unrelated donor hematopoietic stem cell (HSC) transplantation. The protocol describes processes for donor identification, education and evaluation. Procedures for administration and monitoring of the stem cell mobilizing agent filgrastim are included. The study also describes procedures for the collection of PBSC products by leukapheresis and includes provisions for indefinite donor follow-up. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Prospective | ||||||||
| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 15 | ||||||||
| Completion Date | November 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: -Healthy adults Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00511550 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | UC-2508 | ||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | July 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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