Cell Institute | Stem cell preparation related testing

2022-07-16 0 By

To strengthen quality management of stem cells in the preparation and clinical research, in July 2015, the national health and family planning commission (now the national WeiJianWei) and the food and drug supervision administration (now the state food and drug administration) to make the “stem cell preparations before the quality control and clinical research guiding principles (try out)” (hereinafter referred to as “principles”), the requirement has been put on record of clinical research organization,In the preparation and use of stem cell preparations, strict standard operating procedures must be followed to ensure that the quality of stem cell-related preparations can be controlled and the safety and effectiveness of treatment can be guaranteed.The inspection of stem cell preparation can be divided into quality inspection and release inspection.Quality test is a comprehensive quality test to ensure the safety, effectiveness and quality control of stem cells after specific in vitro treatment.Release test is a relatively rapid and simplified cellular test that should be performed preclinical for each batch of stem cell preparation of each type based on the completion of quality test.The Principles provide guidance on the relevant testing contents and requirements of stem cell preparations, including bacteria, fungi, mycoplasma, endogenous and exogenous viruses, abnormal immunological reactions, cell identification, cell activity, cell differentiation ability, tumorigenesis and residue detection, etc. The specific items are as follows:The preparation of stem cells should be carried out in a biological laboratory in accordance with GMP standards. The above items are necessary tests for each batch of cell preparations before they are released from storage and are essential for quality control at all stages of stem cell preparation process.At present, a number of clinical applications of stem cells have been carried out at home and abroad, involving a variety of stem cells and a variety of disease types.Many stem cell types, mesenchymal stem cells derived from bone marrow, adipose tissue, umbilical cord or placental tissue, have some potential for multidirectional differentiation and anti-inflammatory and immunological regulation.At present, more than 200 kinds of diseases, including bone and joint diseases, liver cirrhosis, spinal cord injury and nervous system diseases, have been found to be clinically treated with stem cells.As pointed out in the 12th Five-Year Plan of The National Major Scientific Research Program on Stem Cell Research of the Ministry of Science and Technology, regenerative medicine with stem cell therapy as the core will become another way to treat diseases after drug therapy and surgical therapy, and will also become the core of the new medical revolution.Stem cell-based medicinal Products (STEM cell-based medicinal Products) : a cell medicinal product consisting of various types of stem cells, which is used to treat disease or improve health, and is of appropriate quality and safety standards and has a definite biological effect.Reference: Guidelines for Quality Control of Stem Cell Preparations and Preclinical Studies (Trial) END