Warning from illegal stem cell therapies New
The opportunities of stem cell and other cell-based therapies raise great hopes in physicians as well as patients. Due to novel therapies, major progress is expected particularly in the areas of difficult-to-treat, chronic and incurable diseases. In order to prevent illegal profiteering, it is important for authorities to monitor this quickly evolving therapeutic area.
Patient safety and clinical trials
In recent years, stem cells have been in the focus of medical science. A large number of studies worldwide are aimed to reveal stem cell application for improvement or cure of certain medical conditions. Cell preparations such as stem cells are systematically tested in clinical trials before successful approval. As a result, patients receiving experimental therapies can be sure of proper manufacturing of their therapeutics. Furthermore, the patients are guaranteed to receive a tightly monitored follow-up treatment. Thus obtained scientific evidence is used to increase efficacy as well as safety of novel therapeutic approaches. One of the major criteria of clinical trials is a treatment free of charge for the participant patients.
A world wide problem
Currently the number of suspect notifications is increasing not only in Austria: seriously ill patients are promised cure achieved by novel cellular therapies, such as dendritic cell therapy, in exchange for large sums. Moreover, the manufacturing sites and laboratories are often unknown and thus not subject to the necessary monitoring and quality control by the respective authorities. Therefore, manufacturing quality of the cell preparations is mostly insufficient and it is nontransparent to what extent the respective cells have been manipulated. As a result, it is nearly impossible to predict the actual effect of the administered therapy. For these reasons, prevention of “patient experiments” is one focus of enforcement work.
Contact for reports
If you have any knowledge/information about offers of dendritic cell therapies or other stem cell or cell therapies, please contact enforcement@basg.gv.at or the Federal Office for Safety in Health Care, Enforcement Group, Traisengasse 5, 1200 Vienna.
| Further information Link | Please also see the official warning of the European Medicines Agency (EMA) concerning this matter. |
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