Safety Aspects of Immunoadsorption in IgG Removal Using a Single‐Use,Multiple‐pass Protein A Immunoadsorber (LIGASORB): Clinical Investigation in Healthy Volunteers |
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| Authors: | Sven Süfke Hendrik Lehnert Ingrid Uhlenbusch‐Körwer Frank Gebauer |
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| Affiliation: | 1. University of Lübeck, Lübeck, Germany;2. Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany;3. Fresenius Medical Care Adsorber Tec GmbH, Krems, Austria |
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| Abstract: | Therapeutic apheresis and immunoadsorption are used to deplete efficiently pathogenic autoantibodies in crises in several acute autoimmune driven diseases. This prospective, non‐comparative cohort study was conducted at a single study center under standardized conditions in 10 healthy volunteers. Efficient immunoglobulin G (IgG) removal (?86% versus baseline) was achieved after 3 apheresis treatments on 3 consecutive days. The treatments were well tolerated. Safety laboratory parameters did not show unexpected or pathological changes. The effects were transient, with most parameters exhibiting complete recovery between treatments. Minimal complement activation and moderate transient fibrinogen depletion were observed. Immunoadsorption with LIGASORB® provides a safe and effective treatment alternative to TPE in acute episodes of peripheral neurological diseases mediated by pathogenic IgG autoantibodies. |
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| Keywords: | Apheresis Fibrinogen Immunoadsorption Immunoglobulin G Staphylococcal Protein A |
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