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- Title
Quality assessment and regulatory aspects of autologous and allogeneic peripheral stem cell preparation.
- Authors
Dada A; Rothe G; Schmitz G; Klouche M
- Abstract
In Europe, approximately 17000 stem cell transplantations are carried out annually with an expected increase of at least 10 % per year. About ten years ago, stem cells were harvested mainly from the bone marrow. Today, stem cells are collected predominantly from the peripheral blood (65 %) by apheresis after mobilisation with hematopoietic growth factors. Laboratory diagnosis constitutes an essential part in pre-transplantation monitoring for the timing of the stem cell collection, as well as for the monitoring of the haematologic and immunologic reconstitution. In this field special requirements need to be met for laboratory diagnostic procedures since, currently, most procedures lack standardisation, for many parameters no quality control is established and no external quality control measures exist. On the other hand, the laboratory tests, which are mostly not amenable to automatisation, are strictly regulated by the national legislation and European and national guidelines and recommendations. In this review, we discuss the currently used diagnostic parameters for quality control of stem cell products and the relevant regulatory issues.
- Publication
Journal of Laboratory Medicine / Laboratoriums Medizin, 2002, Vol 26, Issue 7/8, p408
- ISSN
0342-3026
- Publication type
Journal Article