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This detailed book explores the utilization and delivery of stem cells for therapeutic purposes in patients in the clinic and the tightly controlled Good Manufacturing Practices (GMP) that make these powerful techniques possible. Fully updated and expanded from the first edition, this collection features a new set of protocols to arm stem cell biologists with protocols that are currently being used in a number of well-established facilities around the world. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls.
Authoritative and up to date, Stem Cells and Good Manufacturing Practices: Methods, Protocols, and Regulations, Second Edition serves as an ideal guide for researchers aiming to drive continued improvementsto GMP and accelerate new stem cell treatments for patients in need.
List of contents
Swiss Fetal Transplantation Program and Non-Enzymatically Isolated Primary Progenitor Cell Types for Regenerative Medicine.- GMP Tiered Cell Banking of Non-Enzymatically Isolated Dermal Progenitor Fibroblasts for Allogenic Regenerative Medicine.- Progenitor Biological Bandages: An Authentic Swiss Tool for Safe Therapeutic Management of Burns, Ulcers, and Donor Site Grafts.- Validation of the Media Fill Method for Solid Tissue Processing in Good Manufacturing Practice-Compliant Cell Production.- The Isolation, Culturing, Cryopreservation, and the Preparation as a Final Cellular Product of the Umbilical Cord-Derived Mesenchymal Stem Cells Under Good Manufacturing Practices Conditions.- The Isolation, Culture, Cryopreservation, and the Preparation as a Final Cellular Product of the Skin-Derived Fibroblasts Under Good Manufacturing Practice Conditions.- The Isolation and Manufacture of GMP-Grade Bone Marrow Stromal Cells from Bone Specimens.- Scalable Manufacturing of Human Hematopoietic Stem/Progenitor Cells Exploiting a Co-Culture Platform with Mesenchymal Stromal Cells.- GMP-Compatible, Xeno-Free Culture of Human Induced Mesenchymal Stem Cells.- GMP-Grade Methods for Cardiac Progenitor Cells: Cell Bank Production and Quality Control.- Suspension Culture of Human Induced Pluripotent Stem Cells in Single-Use Vertical-WheelTM Bioreactors Using Aggregate and Microcarrier Culture Systems.- Addressing Manufacturing Challenges for Commercialization of iPSC-Based Therapies.- Standard Operating Procedure for the Good Manufacturing Practice-Compliant Production of Human Endometrial Stem Cells for Multiple Sclerosis.- GMP-Compliant Production of Human Placenta-Derived Mesenchymal Stem Cells.- GMP-Compliant Human Schwann Cells Manufacturing for Clinical Application.- GMP-Compliant Adenoviral Vectors for Gene Therapy.- Use of Multipotent Mesenchymal Stromal Cells, Fibrin, and Scaffolds in ihe Production of Clinical Grade Bone Tissue Engineering Products.- QualityManagement Systems (QMSs) of Human Tissue- and Cell-Based Product Manufacturing Facilities.
