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This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.
This book summarizes the progress made across the international medical and scientific research communities towards the goal of converting a chronic autoimmune disease into a drug-free reversible illness using hematopoietic stem cell transplantation (HSCT) and other cellular therapies to generate sustained immune tolerance.
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Autologous hematopoietic stem cell transplantation (AHSCT) was proposed 20 years ago as an alternative therapeutic approach for patients with severe and refractory autoimmune diseases. Since then, this innovative therapy has been successfully used to treat several autoimmune diseases, such as neurological disorders (Multiple Sclerosis), connective tissue diseases (Systemic Sclerosis and Systemic Lupus Erythematous), gastrointestinal inflammatory diseases (Crohn’s Disease) and others (Juvenile Arthritis, Type 1 Diabetes, Vasculitis). Experience in phase I-II and III clinical trials over the years has led to increased safety and efficacy of this procedure. Recent studies have demonstrated su...