Advanced-therapy medicinal products (ATMPs) are medicines for human use that are based on gene therapy, somatic-cell therapy or tissue engineering. They offer groundbreaking new opportunities for the treatment of disease and injury. These therapies relay on novel technologies and legislation for this field in Europe was first accepted only in 2007 to facilitate global marketing of such products. Nevertheless, the market scope of ATMPs is often limited due to logistic requirements and specific characteristics of these products, especially those that are based on living autologous cells. For these reasons, so called hospital exceptions are allowed in certain cases, where use of such products is allowed within national markets. Another aspect of the ATMPs marketing is a global market of patients. This allows patients to get involved in clinical trials all over the world. However, the hype of stem cell therapies and other advanced therapies encourages patient to try treatments in the countries with less or no regulation in this field, where the offered therapies often don't meet standards of EU and other developed countries.
B.04 Guest lecture
COBISS.SI-ID: 513997687Progress in the field of stem cell therapies brings hope to treat certain incurable diseases. The article summarizes the characteristics of stem cells, various types of stem cells depending on the source (embryonic or adult tissue), and differences in their potency. We present the clinical areas where stem cells are already used in the treatment, as well as those for which there is a reasonable hope that in the near future they will become part of an established treatment. The greatest potential of stem cells lies in the treatment of degenerative diseases and traumatic injuries, where we can expect a significant impact on patient's quality of life. Lessons in this area will also assist in the understanding of cancer and immune disorders and provide opportunities for a new approach to the treatment of these diseases.
B.04 Guest lecture
COBISS.SI-ID: 31765721