Generation of mesenchymal stem cells as a medicinal product in organ transplantation

Mesenchymal stem cells (MSCs) are emerging as an alternative treatment in solid-organ transplantation. The use of MSCs as a therapeutic product requires the translation of basic research protocols into a production process under good manufacturing practice (GMP) to obtain a safe product of high quality. This requires a different mindset from the academic setting of changing protocols into a well defined, controlled and documented process. This review describes some of the challenges faced by culturing MSCs as a medicinal product.

Clinical-grade MSCs are used in the clinical trials and proved to be safe as a medicinal product. Because of the differences in the type of MSCs and in the production process, clinical outcome is not always comparable. New standardized methods in the culture condition such as the use of alternatives for fetal bovine serum (FBS), standardized plating densities or the use of bioreactors may further standardize the production process.

To generate MSCs as a medicinal product in organ transplantation, regulation requires that MSCs have to be generated under GMP. During the whole production process, all critical steps should be known and described. Further steps should be taken to optimize and standardize the production process.