Mesenchymal Stromal Cell Production in Academic Centers: Challenges and Opportunities

The clinical applications of mesenchmyal stromal cells (MSCs) are expanding, and academic centers are increasingly involved in preclinical studies and current Good Manufacturing Practices (cGMP) production of MSCs for human trials. MSC manufacturing is fairly straightforward, though it is highly variable across laboratories and often in need of optimization prior to clinical trials. The successful translational development of MSCs relies upon a team of individuals with diverse training and backgrounds (eg, medicine, basic and applied science, medical technology, quality assurance, and regulatory affairs). There are challenges, such as identifying qualified team members and funding sources, balancing workload, and dealing with many trial-specific issues. However, there are also many opportunities, not the least of which is the opportunity for academic centers to play a central role in the advancement of clinical trials with MSCs.