Tissues and tissue preparations are medicinal products in accordance with Section 4 (30) of the German Medicinal Products Act (Arzneimittelgesetz, AMG). Section 63i AMG stipulates that any suspicion of a serious incident or serious adverse reaction must be reported immediately to the competent federal authority by the marketing authorisation or approval holder for tissue preparations. In its latest Tissue Vigilance Report, the Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, provides information on all spontaneous reports from 2023 concerning serious adverse events (SAEs) and serious adverse reactions (SARs) that occurred in connection with the procurement, testing, processing, storage and distribution of tissues and cells and were reported to the Paul-Ehrlich-Institut.
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The report covers SAEs and SARs relating to haematopoietic stem cells, reproductive cells and tissues, musculoskeletal tissues, cardiovascular tissues, ocular tissues, skin tissues and other tissues. Where possible, case-specific details on certain SAEs and SARs are provided. Since only the reporting of serious reactions and serious adverse events is required by law, the Paul-Ehrlich-Institut only receives sporadic information on non-serious events. These reports are therefore not included in the report.
In the 2023 reporting year, 101 suspected donor SARs, 42 suspected recipient SARs, and 46 SAEs were reported to the Paul-Ehrlich-Institut. These SARs and SAEs occurred in haematopoietic stem cells, reproductive cells, musculoskeletal tissues, cardiovascular tissues and ocular tissues. No adverse events were reported for skin tissue, amniotic tissue, umbilical cord tissue, mesenchymal stromal cells (MSC) from the bone marrow, and other tissues such as fatty tissue and keratinocytes. Four deaths were reported in association with the collection and use of tissues and tissue preparations. However, the available data suggested an alternative cause for the deaths, and none could be confirmed to be related to the collection or use of the tissue preparation. Likewise, no reported suspected cases of recipient SARs were confirmed. For all recipient SARs, a causal relationship was ruled out based on the available data as plausible alternative explanations for the reported reactions were available.
This report shows that serious adverse reactions have been reported following the use of tissue preparations; most with a possible causal relationship rather than a confirmed association. This demonstrates the safety and quality of these products.
To obtain the most comprehensive picture possible of the safety profile of tissues and tissue preparations, it is important that all suspected cases of serious adverse reactions and incidents continue to be reported to the Paul-Ehrlich-Institut. The Paul-Ehrlich-Institut provides standardised forms for these reports on its website.
Updated: 31.10.2025
