cell therapy | cellular therapy | cytotherapy

fresh cell therapy

somatic cell therapy medicinal product

cell therapy

cellular therapy [ live cell therapy | fresh cell therapy ]

Foundation for Gene and Cell Therapy

Certain advanced gene therapy and somatic cell therapy medicinal products (e.g. xenogeneic cell therapy and certain gene transfer products) may contain replication-competent particles and/or infectious agents.

This is particularly important in the context of the emergence of new therapies, such as gene therapy and associated cell therapies, and xenogenic somatic therapy.

This procedure, now compulsory for high-technology medicinal products (gene therapy and associated cell therapies, xenogenic therapies) in order to maintain the high level of scientific evaluation and thus to preserve the confidence of medical professionals and patients, will also become compulsory for orphan medicinal products; for products containing a new active substance and indicated for the treatment acquired immune deficiency syndrome, cancer, neurodegenerative disorder or diabetes and, four years after the entry into force of the Regulation, also for the treatment of auto-immune diseases, immune dysfunctions and viral diseases.

6. Written authorisation shall be required before commencing clinical trials involving medicinal products for gene therapy, somatic cell therapy including xenogenic cell therapy and all medicinal products containing genetically modified organisms.