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Historical perspectives and the future of adverse reactions associated with haemopoietic stem cells cryopreserved with dimethyl sulfoxide
Authors:Michael A Cox  Jens Kastrup  Mikulas Hrubi?ko
Institution:1. Danish Medicines Agency, Axel Heides Gade 1, 2300, Copenhagen S, Denmark
2. Department of Cardiology, Rigshospital Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen ?, Denmark
3. Slovak Medical University, Bratislava, Slovakia
Abstract:A retrospective review of the published literature identified several hundred adverse reactions (e.g. nausea, chills, cardiac arrhythmias, neurological symptoms and respiratory arrest) associated with the transplantation of stem cells cryopreserved with dimethyl sulfoxide. The occurrences of these are generally accepted as commonplace, as the majority of reactions are transient, whilst a few patients may require clinical treatment. This exploratory study is a collation of the historical data and the expectations for the notification of serious adverse reactions. Outline information is presented on the development of related European Directives, some technical aspects of dimethyl sulfoxide and the sequential stages of preservation and administration.
Keywords:
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