The overall goal of this study is to provide an advanced manufacturing strategy that will help enhance the yield and effectiveness of manufactured mesenchymal stem cells (MSCs) and the extracellular vesicles (EVs) produced by MSCs.
This collaboration aims to understand what culture parameters regulate the production of MSCs and MSC-derived EVs that can be used to promote immunosuppression and/or vascularization. These studies will enhance our understanding of the cellular mechanisms that regulate both the production rate and potency of MSCs and EVs produced by MSCs. This project is directly in line with the Center for Biologics Evaluation and Research (CBER) mission by providing approaches to improve the safety, quality, and effectiveness of emerging MSC and MSC-derived EV therapies. Additionally, the project aims to help enhance scientific understanding and facilitate assessment of data needs for such novel regulated products. The successful accomplishment of this study will potentially provide manufacturing guidelines that will ultimately enhance key attributes and potency of MSC and MSC-derived EV products, which is in line with the goal of the Office of Tissues and Advanced Therapies (OTAT).