Mobilized Peripheral Blood Stem Cells are Pluripotent and Can Be Safely Harvested and Stored for Cartilage Repair
- PMID: 33940122
- DOI: 10.1016/j.arthro.2021.04.036
Mobilized Peripheral Blood Stem Cells are Pluripotent and Can Be Safely Harvested and Stored for Cartilage Repair
Abstract
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 3 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 4 mL 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. × 106 total viable cells/4 mL vial and 2.1 ± 1.0 × 106 CD34+ cells/4 mL vial. After processing for cryopreservation, the average cell count decreased to 331.3 ± 79. × 106 total viable cells /4 mL vial and 1.5 ± 0.7 × 106 CD34+ cells/4 mL vial CD34+ cells. Preprocessing viability averaged 99% and postprocessing 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.
Copyright © 2021. Published by Elsevier Inc.
Comment in
-
Editorial Commentary: Cell-Based Therapies for Articular Cartilage Repair Require Precise Progenitor Cell Characterization and Determination of Mechanism of Action.Arthroscopy. 2021 Nov;37(11):3357-3359. doi: 10.1016/j.arthro.2021.06.006. Arthroscopy. 2021. PMID: 34740410
-
Regarding "Mobilized Peripheral Blood Stem Cells are Pluripotent and Can be Safely Harvested and Stored for Cartilage Repair".Arthroscopy. 2021 Dec;37(12):3389-3390. doi: 10.1016/j.arthro.2021.09.019. Arthroscopy. 2021. PMID: 34863374 No abstract available.