Generation of clinical grade human bone marrow stromal cells for use in bone regeneration

- A semi-closed system was assembled to develop a cell processing method for clinical grade human BMSCs from aspirates.
- A Drug Master File and an IND for manufacture of autologous BMSCs were approved by the FDA.
- Cells generated by this process maintained their ability to regenerate a bone/marrow organ as demonstrated by in vivo transplantation.

In current orthopaedic practice, there is a need to increase the ability to reconstruct large segments of bone lost due to trauma, resection of tumors and skeletal deformities, or when normal regenerative processes have failed such as in non-unions and avascular necrosis. Bone marrow stromal cells (BMSCs, also known as bone marrow-derived mesenchymal stem cells), when used in conjunction with appropriate carriers, represent a means by which to achieve bone regeneration in such cases. While much has been done at the bench and in pre-clinical studies, moving towards clinical application requires the generation of clinical grade cells. What is described herein is an FDA-approved cell manufacturing procedure for the ex vivo expansion of high quality, biologically active human BMSCs. This article is part of a Special Issue entitled Stem Cells and Bone.