Science and Technology Education Department of the National Health Commission, Working Guidelines for Clinical Research on Somatic Cells (Draft for Comments)

Issued: May 9, 2023

Applicability: The phrase "clinical research on somatic cells" means clinical research using human mature/functionally differentiated autologous or allogeneic cells that have been manipulated in vitro and which are then returned to (or implanted into) the human body as an investigational intervention for disease treatment. These Guidelines shall apply to clinical research on somatic cells that is initiated by researchers at medical institutions and the objective of which is not registration of a pharmaceutical (Section One).

Main contents: Unlike clinical trials of pharmaceuticals, the initial purpose of clinical research on somatic cells is not their marketing, but rather an early clinical exploration conducted based on its previous research base and used to answer certain scientific questions or to prove certain scientific hypotheses.