Advanced Therapies

The topic of Advanced Therapies present an exciting and fascinating developmental area in medicine. Frequently, an overlap of medical device and pharmaceutical legislation is present, resulting in regulatory and clinical development challenges. Consider several examples, where the Advanced Therapies are regulataed within their own right, however the application of the therapy is difficult to imagine without appropriate medical device products to collect, process and deliver such therapies to patients:

  • Autologous chondrocytes seeded onto a collagen membrane and administered into a joint cartilage lesion. Viable cells repair the damaged tissue, while the medical device portion physically retains the cells on the cartilage defect.
  • Autologous osteoprogenitor cells, isolated from bone marrow, grown within and around a bioresorbable scaffold that acts as physical support. The integrated product consists of a cellular component and a biodegradable medical device matrix.
  • Genetically engineered cells – where a recombinant human gene in a mammalian expression vector is introduced into human cells through transfection and resulting cells are further cultured in vitro – incorporate as an integral part of the product two components: a semipermeable hollow fibre membrane capsule and a scaffold of strands of polyethylene terephthalate yarn.
  • Human endothelial cells cultured in a gelatin matrix used to reduce intimal thickening of vessels injured by frequent hemodialysis procedures. The gel matrix is a CE marked medical device. The cells are a medicinal product.
  • Isolated pancreatic beta cells embedded in an alginate matrix – this cell-based product administered to restore, correct or modify physiological function (secretion of insulin).
  • Autologous bone marrow-derived progenitor cells intended for treatment of patients with myocardial infarction are associated with a medical device delivery component.
  • Autologous human keratinocytes for the treatment of acute burns provide transient repair of the underlying structure, later replaced. The tissue collection, cell separation processing and reintroduction are achieved through medical device technologies.