EMA, the European Drug Regulators, Publish Draft Guidance on Non-Clinical and Clinical Aspects of Medical Products Containing Genetically Modified Cells.
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This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans. Its focus is on the quality, safety and efficacy requirements of genetically modified cells developed as medicinal products.
Genetically modified cells may be developed either for therapeutic use (gene therapy medicinal products) or to use the genetic modification in the manufacturing process of a cell therapy / tissue engineering product.
The following are some examples of medicinal products containing genetically modified cells (GMC) that have been used in clinical trials:
genetically modified cells for treatment of monogeneic inherited disease;
genetically modified dendritic cells and cytotoxic lymphocytes for cancer immunotherapy;
genetically modified autologous chondrocytes for cartilage repair; genetically modified progenitor cells for cardio-vascular disease treatment or for in vivo marking studies, particularly for in vivo biodistribution or in vivo differentiation analysis;
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genetically modified osteogenic cells for bone fractures repair; genetically modified cells for 66 infectious disease treatment.
This guideline defines scientific principles and provides guidance to applicants developing medicinal products containing genetically modified cells. It is recognised that this is an area under constant development and guidance should be applied to any novel procedures as appropriate.
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