Comparison of MSC Manufactured at Different Centers

Mesenchymal Stem Cells are widely used in clinical trials. They are manufactured in different centers with variable conditions including donor, source of starting material, culture conditions etc. Their use and release criteria are also variable. The focus of this study is to answer the following questions: 1. Describe differences in BMSC manufacturing among centers 2. Identify differences, if any, due to manufacturing on product quality 3. Identify the most important sources of variability Each participating site provides several samples for analysis. The evaluation will include descriptive characteristics (e.g. starting material, methods, surface marker expression etc); as well as gene expression analysis. Additional studies will include murine transplantation studies with assessment of in vivo bone and cartilage formation and support of hematopoiesis

Completed

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CT

Stroncek