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Uppsala, Sweden

Barkholt L.,European Medicines Agency | Barkholt L.,Medical Products Agency MPA | Flory E.,European Medicines Agency | Flory E.,Paul Ehrlich Institute | And 22 more authors.
Cytotherapy | Year: 2013

In the past decade, the therapeutic value of mesenchymal stromal cells (MSCs) has been studied in various indications, thereby taking advantage of their immunosuppressive properties. Easy procurement from bone marrow, adipose tissue or other sources and conventional in vitro expansion culture have made their clinical use attractive. Bridging the gap between current scientific knowledge and regulatory prospects on the transformation potential and possible tumorigenicity of MSCs, the Cell Products Working Party and the Committee for Advanced Therapies organized a meeting with leading European experts in the field of MSCs. This meeting elucidated the risk of potential tumorigenicity related to MSC-based therapies from two angles: the scientific perspective and the regulatory point of view. The conclusions of this meeting, including the current regulatory thinking on quality, nonclinical and clinical aspects for MSCs, are presented in this review, leading to a clearer way forward for the development of such products. Copyright © 2013, International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Kimland E.,Karolinska University Hospital | Kimland E.,Medical Products Agency MPA | Nydert P.,Karolinska University Hospital | Odlind V.,Medical Products Agency MPA | And 2 more authors.
Acta Paediatrica, International Journal of Paediatrics | Year: 2012

Aim: To perform a nationwide investigation of paediatric drug use at Swedish hospitals, including an analysis of off-label drug use. Methods: All paediatric hospitals in Sweden were invited to register all prescriptions to children, aged between 0 and 18, during two separate 2-day-periods in 2008. Data were reported and analysed with respect to licence status and proportion of and reasons for off-label drug use. Results: Data on 11 294 prescriptions to 2947 paediatric patients were received. Drugs associated with pain relief, infection, prematurity, nutrition and surgery or anaesthesia were most commonly used. Paracetamol was the most frequently used drug on-label and also among the most commonly used off-label drugs. Nearly half (49%) of all administered prescriptions concerned unlicensed drugs, off-label drugs or extemporaneously prepared drugs. The corresponding rate among neonates was 69%. Lack of paediatric information in the Summary of Product Characteristics was the main reason for off-label classification. Conclusions: Paediatric off-label drug use is common at Swedish hospitals, and nearly half of all prescriptions were not documented for use in children. The findings emphasize a need for paediatric clinical studies as well as compilation of existing clinical experience and scattered evidence, particularly for drug treatment in infants and neonates. © 2012 Foundation Acta Pædiatrica.

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