Illegal stem cell therapies

Enforcement | 06/04/2019

Great hopes of physicians as well as patients are attached to stem cell and other cell-based therapies. Major progress is expected particularly in the areas of difficult-to-treat and chronic diseases. In order to prevent hope to be transformed into a “trade with hope”, it is important for authorities to monitor this new therapeutic area.

Successful enforcement operation

The department for enforcement of the Austrian Federal Office for Safety in Health Care (BASG) has lately achieved great success in the fight against illegal experimental cell-based therapies. The smooth cooperation with the Federal Criminal Police Office, international regulatory authorities, Austrian customs and the Viennese municipal authorities resulted in a final punitive decision concerning an Austrian practitioner. In collaboration with a foreign colleague, the physician offered a treatment concept involving unauthorized cell preparations. The patients had to bear the substantial costs for the therapies on their own. The status of the applied cellular therapeutics is experimental, which means that clinical data concerning safety and efficacy are not available. Additionally, the respective cell preparations were mostly produced abroad, in non-authorized laboratories which were not subjected to regulatory controls.

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 applicationfor 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

In addition to the initially described case, the number of suspect notifications is increasing not only in Austria: terminally ill patients are promised cure achieved by novel cellular therapies in exchange for large sums. The problem: usually, experimental techniques without proper authorization are applied. Moreover, the manufacturing quality of the cell preparations is mostly insufficient and it is unclear 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.