Mobilized Peripheral Blood Stem Cells are Pluripotent and Can be Safely Harvested and Stored for Cartilage Repair.

Purpose The primary objective of this study was to reproduce and validate the harvest, processing and storage of peripheral blood stem cells for a subsequent cartilage repair trial, evaluating safety, reliability, and potential to produce viable, sterile stem cells. Methods Ten healthy subjects (aged 19-44 years) received three consecutive daily doses of filgrastim followed by an apheresis harvest of mononuclear cells on a fourth day. In a clean room, the apheresis product was prepared for cryopreservation and processed into 4mL aliquots. Sterility and qualification testing were performed pre-processing and post-processing at multiple time points out to 2 years. Eight samples were shipped internationally to validate cell transport potential. One sample from all participants was cultured to test proliferative potential with colony forming unit (CFU) assay. Five samples, from 5 participants were tested for differentiation potential, including chondrogenic, adipogenic, osteogenic, endoderm, and ectoderm assays. Results Fresh aliquots contained an average of 532.9 ± 166. x106 total viable cells /4mL vial and 2.1 ± 1.0 x106 CD34+ cells /4mL vial. After processing for cryopreservation, the average cell count decreased to 331.3 ± 79. x106 total viable cells /4mL vial and 1.5 ± 0.7 x106 CD34+ cells /4mL vial CD34+ cells. Pre-processing viability averaged 99% and post-processing 88%. Viability remained constant after cryopreservation at all subsequent time points. All sterility testing was negative. All samples showed proliferative potential, with average CFU count 301.4 ± 63.9. All samples were pluripotent. Conclusions Peripheral blood stem cells are pluripotent and can be safely harvested/stored with filgrastim, apheresis, clean-room processing, and cryopreservation. These cells can be stored for 2 years and shipped without loss of viability. Clinical relevance This method represents an accessible stem cell therapy in development to augment cartilage repair.