摘要 |
PROBLEM TO BE SOLVED: To provide a method of preparing a master cell bank composition comprising mesenchymal stem cells, for preparing mesenchymal stem cells for clinical applications as therapeutic compositions (called investigational drugs/investigational medicinal products).SOLUTION: A composition comprises mesenchymal stem cells, fetal bovine serum (FBS) and dimethyl sulfoxide (DMSO); or mesenchymal stem cells, Plasmalyte A(R), human serum albumin (HSA) and DMSO, optionally along with pharmaceutically acceptable additives. The mesenchymal stem cells have a concentration of 25 million to 200 million cells per 15 ml, the HSA has a concentration of 1-6%, the Plasmalyte A has a concentration of 80-90%, and the DMSO has a concentration of 5-10% in each cryo-preserved vial. |