The Committee for Advanced Therapies (CAT) from the European Medicine Agency (EMA) has classified the NK cell technology developed by CiMaas as somatic cell therapy medicinal product with the indication for acute myeloid leukaemia.

According to the EMA is our product NK-Xpand-AML1 a biological medicinal product as the active substance allogeneic natural killer cells expanded in vitro is extracted from a biological source donor blood of human origin.  The characterization and the determination of its quality require a combination of physico-chemical-biological testing, together with the production process and its control. 

Wilfred Germeraad, CSO of CiMaas comments positively: “this qualification is part of the recognition of our technology and paves the way for clinical application in patients with AML.”

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