Module 18 2021

CAT Classification Decisions

Product

Indication Classificatio n

adipose tissue-derived mesenchymal stem cells expanded ex vivo combined with biomaterial β - TCP Cultured autologous adipose-derived stem cells on a polypropylene tubular scaffold Encapsulated human retinal pigment epithelial cells genetically modified to express human factor IX protein Allogeneic human Wharton’s jelly-derived mesenchymal stem cells seeded onto decellularized dermal scaffold

Bone defects

TEP, combined

Radical cystectomy in bladder cancer

TEP, combined

Haemophilia B GT, combined

Epidermolysis bullosa

TEP, not combined

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TOPRA MSc Module 18: Drug Device Combinations and other Technology