Abstract:
:The widespread use of tissue including hematopoietic stem cell products is justification for the development of standards by professional societies and for regulation by governmental agencies. The Food and Drug Administration (FDA) developed a tiered, risk-based regulatory model. At the low end of risk to the tissue recipient, the regulations being developed by the FDA are comparable to standards developed by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) and recognize a basic level of practice in the collection, processing, and distribution of hematopoietic stem cell (HSC) products. This basic level of practice, when fully enacted, will be found in part 1,271 of chapter 21 of the Code of Federal Regulations (CFR), which includes criteria for facility management, quality control, donor selection, and the processing of cells. The regulatory approach adopted by the FDA is more comprehensive than FAHCT standards, however. It defines higher levels of regulatory oversight that combines appropriate sections of part 1271 with current good manufacturing practice requirements described in parts 210, 211, and 820 of chapter 21 of the CFR for HSC products that are more than minimally manipulated.
journal_name
Int J Hematoljournal_title
International journal of hematologyauthors
Rowley SDdoi
10.1007/BF02982036subject
Has Abstractpub_date
2002-04-01 00:00:00pages
237-45issue
3eissn
0925-5710issn
1865-3774journal_volume
75pub_type
杂志文章,评审abstract::We describe the case of a 62-year-old man with biopsy-proven cardiac involvement of multiple myeloma-associated immunoglobulin light-chain amyloidosis, whose cardiac function improved after bortezomib therapy. Angiotensin-converting enzyme inhibitors and diuretics were initially administered, resulting in improvement ...
journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1007/s12185-010-0710-x
更新日期:2010-11-01 00:00:00
abstract::The antitumor effect of high-dose chemotherapy (HDC) followed by autologous peripheral blood stem cell transplantation (auto-PBSCT) is considered superior to that of conventional chemotherapy. However, the long-term benefits of this strategy in Japan remain unclear. Therefore, in this study, 109 cancer patients enroll...
journal_title:International journal of hematology
pub_type: 临床试验,杂志文章,多中心研究
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abstract::Thrombomodulin (TM) is an endothelial cell membrane glycoprotein which modulates coagulation via the formation of thrombin-TM complexes. We investigated the human megakaryoblastic cell line (UT-7) for the presence of functional TM on the cell surface and in cell lysates using a specific enzyme-linked immunosorbent ass...
journal_title:International journal of hematology
pub_type: 杂志文章
doi:
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journal_title:International journal of hematology
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journal_title:International journal of hematology
pub_type: 杂志文章
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更新日期:2020-10-19 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1007/s12185-013-1258-3
更新日期:2013-02-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章,评审
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更新日期:2014-10-01 00:00:00
abstract::Imatinib mesylate and rituximab are molecularly targeted drugs against the BCR-ABL fusion protein and the CD20 antigen, respectively. Although these drugs have excellent anticancer effects, a major concern is drug resistance. We have investigated the case of a patient with Philadelphia chromosome-positive and CD20+ ac...
journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1532/ijh97.04033
更新日期:2004-07-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1007/s12185-009-0380-8
更新日期:2009-09-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1007/s12185-016-2108-x
更新日期:2017-02-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章
doi:
更新日期:2000-01-01 00:00:00
abstract::Since the presence of erythroblasts (Ebl) in the peripheral blood of patients suspected to have aplastic anemia (AA) has been thought to suggest an error in diagnosis, such patients may not receive appropriate therapy promptly, with potentially fatal results. However, we recently experienced patients who had the typic...
journal_title:International journal of hematology
pub_type: 杂志文章
doi:
更新日期:1994-08-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1532/IJH97.06227
更新日期:2007-05-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1007/s12185-011-0809-8
更新日期:2011-03-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1007/s12185-011-0952-2
更新日期:2011-11-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章
doi:
更新日期:1994-10-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1016/0925-5710(95)00365-y
更新日期:1995-06-01 00:00:00
abstract::A 2-year-old Japanese boy who presented with multiple cervical, axillary, and inguinal lymphadenopathy was diagnosed by immunocytochemical analysis as having myeloid/natural killer (NK) cell precursor acute leukemia. Leukemic blasts in the bone marrow were positive for CD56 (NK marker), CD7 (T-cell marker), CD33 (myel...
journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1007/BF02982029
更新日期:2002-02-01 00:00:00
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journal_title:International journal of hematology
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journal_title:International journal of hematology
pub_type: 杂志文章
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更新日期:2014-04-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章
doi:
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pub_type: 杂志文章
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更新日期:2019-06-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1007/s12185-008-0098-z
更新日期:2008-07-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章,meta分析,评审
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更新日期:2017-10-01 00:00:00
abstract::Cytomegalovirus (CMV) infection/reactivation is a serious complication after hematopoietic cell transplantation (HCT). The DNA vaccine ASP0113 contains two plasmids encoding CMV antigens (glycoprotein B and tegument phosphoprotein 65) that stimulate humoral and cellular immunity. Between June 2013 and February 2014, A...
journal_title:International journal of hematology
pub_type: 杂志文章,多中心研究
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更新日期:2017-02-01 00:00:00
abstract::Increased levels of asparagine synthetase (ASNS), an enzyme producing intracellular asparagine, have been implicated in the development of asparaginase resistance. The aim of this study was to assess ASNS mRNA and protein expression in bone marrow cell populations of children with acute lymphoblastic leukemia (ALL). B...
journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1007/s12185-014-1509-y
更新日期:2014-03-01 00:00:00
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journal_title:International journal of hematology
pub_type: 杂志文章,评审
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journal_title:International journal of hematology
pub_type: 临床试验,杂志文章
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更新日期:2013-03-01 00:00:00
abstract::CD5+ diffuse large B-cell lymphoma (DLBCL) has recently been identified as a subgroup with different clinical characteristics from CD5- DLBCL and as having a poorer outcome than CD5- DLBCL. Data regarding differences in gene alteration between CD5+ and CD5- DLBCL have accumulated. In this article, we report an analysi...
journal_title:International journal of hematology
pub_type: 杂志文章
doi:10.1532/ijh97.04119
更新日期:2005-01-01 00:00:00
abstract::To investigate the expression of activation molecules on CD5(+)B lymphocytes in peripheral blood of autoimmune hemolytic anemia (AIHA)/Evans patients. The expression of CD80, CD86, and CD69 on CD5(+)B lymphocytes was detected using flow cytometry in 30 AIHA/Evans patients, 18 normal controls (NC) and nine chronic lymp...
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pub_type: 杂志文章
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更新日期:2016-05-01 00:00:00