Source: Drug Testing Center, State Food and Drug Administration

On January 18, 2024, CDE issued the "Technical Guidelines for Clinical Trials of Mesenchymal Stem Cells for Prevention and Treatment of graft-versus-host Disease", the full text of the notice and guidelines is as follows:

The clinical study of mesenchymal stem cells involving many indications has been carried out at home and abroad, and the clinical study of graft-versus-host disease has made rapid progress. At present, there are no relevant technical guidelines for clinical trials at home and abroad. In order to provide suggestions for clinical trials on prevention and treatment of graft-versus-host disease by mesenchymal stem cells, improve the efficiency of research and application of related products, and meet the clinical needs of patients as soon as possible, the Center for Drug Approval has drafted the Technical Guidelines for clinical trials on Prevention and treatment of graft-versus-host disease by mesenchymal stem cells (see annex).

In accordance with the requirements of the Notice of the General Department of the State Drug Administration on the Issuance Procedure of the Technical Guidelines for Printing and Distributing Drugs (Comprehensive Drug Administration (2020) No. 9), the above guidelines are now issued with the approval of the State Drug Administration and will come into force as of the date of issuance.

Annex: Technical Guidelines for Clinical trials of Mesenchymal Stem cells against graft-versus-host disease (Trial)