EMEA: Guideline on xenogeneic cell-based medicinal products

Xenogeneic cell-based therapy is the use of viable animal somatic cell preparations, suitably adapted for: (a) implantation/ infusion into a human recipient or (b) extracorporeal treatment through bringing (non-human) animal cells into contact with human body fluids, tissues or organs. The principal objective is reconstitution of cell/tissue/organ functions. The genotype and/or phenotype of the cells may have been modified, e.g. by isolation, culture, expansion, pharmacological treatment or combination with various matrices.

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