Results from a horizon scan on risks associated with transplantation of human organs, tissues and cells: from donor to p

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Results from a horizon scan on risks associated with transplantation of human organs, tissues and cells: from donor to patient C. A. Herberts • M. V. D. Z. Park • J. W. G. A. Pot • C. G. J. C. A. de Vries

Received: 13 August 2013 / Accepted: 16 April 2014 Ó Springer Science+Business Media Dordrecht 2014

Abstract The successful transplantation of human materials such as organs, tissues and cells into patients does not only depend on the benefits, but also on the mitigation of risks. To gain insight into recent publications on risks associated with the process of transferring human materials from donor to recipient we performed a horizon scan by reviewing scientific literature and news websites of 2011 on this subject. We found there is ample information on how extended donor criteria, such as donor age, affect the survival rates of organs or patients. Interestingly, gender mismatch does not appear to be a major risk factor in organ rejection. Data on risks of donor tumor transmission was very scarce; however, risk categories for various tumor types have been suggested. In order to avoid rejection, a lot of research is directed towards engineering tissues from a patient’s own tissues and

Electronic supplementary material The online version of this article (doi:10.1007/s10561-014-9450-0) contains supplementary material, which is available to authorized users. C. A. Herberts Section on Pharmacology, Toxicology and Biotechnology, Medicines Evaluation Board (MEB), P.O. Box 8275, 3503 RG Utrecht, The Netherlands M. V. D. Z. Park  J. W. G. A. Pot  C. G. J. C. A. de Vries (&) Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA Bilthoven, The Netherlands e-mail: [email protected]

cells. Some but not all of these developments have reached the clinic. Developments in the field of stem cell therapy are rapid. However, many hurdles are yet to be overcome before these cells can be applied on a large scale in the clinic. The processes leading to genetic abnormalities in cells differentiated from stem cells need to be identified in order to avoid transplantation of aberrant cells. New insights have been obtained on storage and preservation of human materials, a critical step for success of their clinical use. Likewise, quality management systems have been shown to improve the quality and safety of human materials used for transplantation. Keywords Medical use  Human organ  Human tissue  Human cells  Risk  Procurement  Processing  Donation

Introduction The use of human organs, tissues and cells has been offering great opportunities to treat a large variety of diseases and conditions for several decades. The field of medical use of human organs, tissues and cells is evolving rapidly, and knowledge on the use of these human materials and the available accompanying techniques have increased substantially in the last decade. Novel use of stem cells and improved methods to engineer tissues are continuously being invented. However, the use of hum