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Allogeneic Cell Therapy Companies: Revolutionizing Treatment Through Off-the-Shelf Therapies
Author: Dr. Anya Sharma, PhD, a leading researcher in cellular immunology with over 15 years of experience in the development and application of allogeneic cell therapies. Her work has been published extensively in peer-reviewed journals and she holds several patents in the field.
Publisher: BioTech Insights, a leading publisher of scientific and medical information specializing in cutting-edge advancements in biotechnology and pharmaceutical research.
Editor: Dr. Benjamin Lee, MD, PhD, a seasoned medical editor with expertise in hematology and oncology. He has overseen the publication of numerous articles on cell therapy and related topics.
Keywords: allogeneic cell therapy companies, off-the-shelf therapies, CAR T-cell therapy, allogeneic CAR T cells, cell therapy manufacturing, gene editing, immune cell therapies, allogeneic NK cells, allogeneic MSCs, clinical trials allogeneic cell therapy.
Introduction:
The field of cell therapy is undergoing a dramatic transformation, driven largely by the emergence of allogeneic cell therapy companies. Unlike autologous therapies, which use a patient's own cells, allogeneic therapies employ cells derived from a donor, offering the potential for "off-the-shelf" treatments. This removes the time-consuming and expensive process of isolating and expanding a patient's cells, making treatment more accessible and potentially faster. This article explores the various methodologies and approaches employed by allogeneic cell therapy companies to develop and commercialize these transformative therapies.
H1: Methodologies Employed by Allogeneic Cell Therapy Companies
H2: Gene Editing Technologies
A significant advancement driving the progress of allogeneic cell therapy companies is the incorporation of gene editing technologies. CRISPR-Cas9, TALENs, and zinc-finger nucleases are employed to modify donor cells, mitigating the risk of graft-versus-host disease (GvHD). This involves removing or inactivating genes responsible for immune rejection, while simultaneously enhancing the therapeutic efficacy of the cells. Many allogeneic cell therapy companies are focusing on this approach, particularly in the development of allogeneic CAR T-cells and Natural Killer (NK) cells.
H2: Immune Cell Engineering
Engineering immune cells, like T cells and NK cells, is a cornerstone of many allogeneic cell therapy companies' efforts. CAR T-cell therapy, a revolutionary treatment for certain cancers, is now being adapted for allogeneic use. This involves genetically modifying donor T-cells to express chimeric antigen receptors (CARs) that target specific cancer cells. Significant challenges remain in controlling GvHD, but advancements in gene editing and immune modulation are making allogeneic CAR T-cell therapy a rapidly developing area. Similarly, allogeneic NK cells are being explored due to their ability to kill cancer cells without causing significant GvHD.
H2: Mesenchymal Stromal Cells (MSCs)
Allogeneic cell therapy companies are also actively developing therapies based on mesenchymal stromal cells (MSCs). MSCs are multipotent stromal cells that can differentiate into various cell types and possess immunomodulatory properties. Their allogeneic nature makes them attractive candidates for treating various conditions, including inflammatory diseases, graft-versus-host disease, and tissue repair. The relative ease of expansion and cryopreservation of MSCs makes them cost-effective for large-scale manufacturing.
H2: Manufacturing and Scale-up
A major hurdle for allogeneic cell therapy companies is the efficient and consistent manufacturing of these therapies at scale. This requires robust and standardized processes that ensure the quality, safety, and efficacy of the final product. Many companies are investing heavily in advanced biomanufacturing technologies, including automation and closed-system processes, to streamline production and meet the growing demand. This is crucial for making these therapies widely accessible and affordable.
H1: Approaches to Mitigating GvHD
One of the primary challenges in allogeneic cell therapy is preventing graft-versus-host disease (GvHD), a potentially fatal complication where donor immune cells attack the recipient's tissues. Allogeneic cell therapy companies are employing several approaches to minimize this risk:
H2: HLA Matching and Selection
Careful selection of donors based on human leukocyte antigen (HLA) matching with the recipient can reduce the risk of GvHD. Advances in HLA typing and donor registries are facilitating better matching.
H2: Immune Suppression
The use of immunosuppressive drugs can help prevent GvHD, but careful management is needed to avoid compromising the immune system's ability to fight off infections or cancer.
H2: Genetic Engineering
As mentioned earlier, gene editing technologies are being used to modify donor cells to reduce their immunogenicity and minimize the risk of GvHD.
H2: Immune Modulation
Strategies that modulate the recipient's immune system or the donor cells’ activity are also under investigation to reduce GvHD risk.
H1: Clinical Trials and Regulatory Landscape
Numerous clinical trials are evaluating the safety and efficacy of various allogeneic cell therapies. The regulatory landscape is evolving rapidly, with agencies like the FDA and EMA establishing guidelines for the development and approval of these novel therapies. The success of these clinical trials will be crucial in determining the widespread adoption of these therapies.
H1: Future Directions for Allogeneic Cell Therapy Companies
The future of allogeneic cell therapy companies is bright, with ongoing research focused on:
Expanding the therapeutic applications: Moving beyond oncology to treat autoimmune diseases, neurodegenerative disorders, and other conditions.
Improving manufacturing efficiency: Developing more scalable and cost-effective manufacturing processes.
Enhancing cell persistence and efficacy: Improving the longevity and effectiveness of transplanted cells.
Developing personalized allogeneic therapies: Combining the advantages of allogeneic and autologous approaches.
Conclusion:
Allogeneic cell therapy companies are at the forefront of a revolution in medicine, offering the promise of accessible and potentially curative therapies for a wide range of diseases. The development of sophisticated gene editing technologies, improved manufacturing processes, and a deeper understanding of immune regulation are driving remarkable progress in this field. While challenges remain, particularly in mitigating GvHD and ensuring long-term efficacy, the ongoing research and development efforts by allogeneic cell therapy companies are paving the way for a future where off-the-shelf cell therapies become a standard of care for many patients.
FAQs:
1. What is the difference between allogeneic and autologous cell therapy? Allogeneic uses donor cells, while autologous uses the patient's own cells.
2. What are the advantages of allogeneic cell therapies? Off-the-shelf availability, potentially faster treatment, and lower cost compared to autologous therapies.
3. What is graft-versus-host disease (GvHD)? A potentially fatal complication where donor immune cells attack the recipient's tissues.
4. How is GvHD prevented in allogeneic cell therapies? Through HLA matching, immunosuppressive drugs, gene editing, and immune modulation.
5. What types of cells are commonly used in allogeneic cell therapies? T cells, NK cells, and MSCs.
6. What are the current applications of allogeneic cell therapies? Primarily oncology, but expanding to other areas.
7. What are the regulatory hurdles for allogeneic cell therapies? Rigorous safety and efficacy testing required by regulatory agencies.
8. What is the future outlook for allogeneic cell therapy companies? Expansion into new therapeutic areas, improved manufacturing, and potentially personalized approaches.
9. How are allogeneic cell therapy companies addressing scalability challenges? Through investments in advanced biomanufacturing technologies and automation.
Related Articles:
1. "CRISPR-Cas9 in Allogeneic CAR T-cell Therapy: Overcoming Challenges and Achieving Clinical Success": Discusses the use of CRISPR technology in developing safer and more effective allogeneic CAR T-cell therapies.
2. "Allogeneic NK Cell Therapies: A Promising Frontier in Cancer Immunotherapy": Explores the therapeutic potential of allogeneic NK cells in treating various cancers.
3. "Manufacturing Challenges and Solutions in Allogeneic Cell Therapy Production": Focuses on the technical aspects of manufacturing allogeneic cell therapies at scale.
4. "The Role of Gene Editing in Preventing Graft-Versus-Host Disease in Allogeneic Cell Therapies": Details the applications of gene editing technologies in mitigating GvHD.
5. "Clinical Trials of Allogeneic Cell Therapies: A Review of Recent Advances": Provides an overview of the current clinical trial landscape for allogeneic cell therapies.
6. "The Regulatory Landscape for Allogeneic Cell Therapies: A Global Perspective": Analyzes the regulatory pathways for the approval of allogeneic cell therapies worldwide.
7. "Economic Considerations of Allogeneic Cell Therapies: Cost-Effectiveness and Access": Discusses the economic aspects of allogeneic cell therapy and its potential impact on healthcare systems.
8. "Allogeneic Mesenchymal Stromal Cells: Therapeutic Applications and Future Directions": Explores the therapeutic potential of allogeneic MSCs in various diseases.
9. "The Ethical Considerations of Allogeneic Cell Therapies: Donor Consent and Equity of Access": Addresses ethical implications associated with the use of donor cells in therapeutic applications.
| allogeneic cell therapy companies: Ex Vivo Cell Therapy Klaus Schindhelm, Robert Nordon, 1999 R.E. Nordon and K. Schindhelm, Introduction. -- L. Robb, A.G. Elefanty, and C.G. Begley, Transcriptional Control of Hematopoieses. -- R. Starr and N.A. Nicola, Cell Signaling by Hemopoietic Growth Factor Receptors. -- P.J. Simmons, D.N. Haylock, and J.-P. Lévesque, Influence of Cytokines and Adhesion Molecules on Hematopoietic Stem Cell Development. -- P.A. Rowlings, Allogeneic Hematopoietic Stem Cell Transplantation. -- U. Hahn and L.B. To, Autologous Stem Cell Transplantation. -- M.R. Vowels, Cord Blood Stem Cell Transplantation. -- S.R. Riddell, E.H. Warren, D. Lewinsohn, C. Yee, and P.D. Greenberg, Reconstitution of Immunity by Adoptive Immunotherapy with T Cells. -- L.Q. Sun, M. Miller, and G. Symonds, Exogenous Gene Transfer into Lymphoid and Hematopoietic Progenitor Cells. -- C. Dowding, T. Leemhuis, A. Jakubowski, and C. Reading, Process Development for Ex Vivo Cell Therapy. -- R.E. Nordon and K. Schindhelm, Cell Separation. -- P.W. Zandstra, C.J. Eaves, and J.M. Piret, Environ ... |
| allogeneic cell therapy companies: Splicing Life United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1982 |
| allogeneic cell therapy companies: Haploidentical Transplantation Stefan O. Ciurea, Rupert Handgretinger, 2018-05-03 In this book, world-renowned experts in the field express well-reasoned opinions on a range of issues and controversies relating to haploidentical transplantation with the aim of providing practicing hematologists with clinically relevant and readily applicable information. Among the areas covered are graft manipulation and methods to control T-cell alloreactivity, the nature of the ideal graft and donor, haploidentical transplantation in pediatric and adult patients with malignant and nonmalignant diseases, immunologic reconstitution following transplantation, complications, and the prevention and treatment of relapse post transplantation. Attention is drawn to the implications of high-impact clinical trials whenever such trials are available. The readily intelligible text is complemented by numerous helpful tables, algorithms, and figures. The book will provide practical support for hematologists and transplant physicians as they attempt to provide optimal care in this exciting but increasingly complex medical specialty. |
| allogeneic cell therapy companies: Regulatory Aspects of Gene Therapy and Cell Therapy Products Maria Cristina Galli, Mercedes Serabian, 2015-09-15 This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent must-know guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals. |
| allogeneic cell therapy companies: Regenerative Biology and Medicine David L. Stocum, 2012-06-07 Regenerative Biology and Medicine, Second Edition — Winner of a 2013 Highly Commended BMA Medical Book Award for Medicine — discusses the fundamentals of regenerative biology and medicine. It provides a comprehensive overview, which integrates old and new data into an ever-clearer global picture. The book is organized into three parts. Part I discusses the mechanisms and the basic biology of regeneration, while Part II deals with the strategies of regenerative medicine developed for restoring tissue, organ, and appendage structures. Part III reflects on the achievements of regenerative biology and medicine; future challenges; bioethical issues that need to be addressed; and the most promising developments in regenerative medicine. The book is designed for multiple audiences: undergraduate students, graduate students, medical students and postdoctoral fellows, and research investigators interested in an overall synthesis of this field. It will also appeal to investigators from fields not directly related to regenerative biology and medicine, such as chemistry, informatics, computer science, mathematics, physics, and engineering. - Highly Commended 2013 BMA Medical Book Award for Medicine - Includes coverage of skin, hair, teeth, cornea, and central neural tissues - Provides description of regenetive medicine in digestive, respiratory, urogenital, musculoskeletal, and cardiovascular systems - Includes amphibians as powerful research models with discussion of appendage regeneration in amphibians and mammals |
| allogeneic cell therapy companies: Cell and Gene Therapies Miguel-Angel Perales, Syed A. Abutalib, Catherine Bollard, 2018-11-27 In this book, experts in the field express their well-reasoned opinions on a range of complex, clinically relevant issues across the full spectrum of cell and gene therapies with the aim of providing trainee and practicing hematologists, including hematopoietic transplant physicians, with information that is relevant to clinical practice and ongoing research. Each chapter focuses on a particular topic, and the concise text is supported by numerous working tables, algorithms, and figures. Whenever appropriate, guidance is provided regarding the availability of potentially high-impact clinical trials. The rapid evolution of cell and gene therapies is giving rise to numerous controversies that need to be carefully addressed. In meeting this challenge, this book will appeal to all residents, fellows, and faculty members responsible for the care of hematopoietic cell transplant patients. It will also offer a robust, engaging tool to aid vital activities in the daily work of every hematology and oncology trainee. |
| allogeneic cell therapy companies: Progenitor and Stem Cell Technologies and Therapies Anthony Atala, 2012-03-15 Progenitor and stem cells have the ability to renew themselves and change into a variety of specialised types, making them ideal materials for therapy and regenerative medicine. Progenitor and stem cell technologies and therapies reviews the range of progenitor and stem cells available and their therapeutic application.Part one reviews basic principles for the culture of stem cells before discussing technologies for particular cell types. These include human embryonic, induced pluripotent, amniotic and placental, cord and multipotent stem cells. Part two discusses wider issues such as intellectual property, regulation and commercialisation of stem cell technologies and therapies. The final part of the book considers the therapeutic use of stem and progenitor cells. Chapters review the use of adipose tissue-derived stem cells, umbilical cord blood (UCB) stem cells, bone marrow, auditory and oral cavity stem cells. Other chapters cover the use of stem cells in therapies in various clinical areas, including lung, cartilage, urologic, nerve and cardiac repair.With its distinguished editor and international team of contributors, Progenitor and stem cell technologies and therapies is a standard reference for both those researching in cell and tissue biology and engineering as well as medical practitioners investigating the therapeutic use of this important technology. - Reviews the range of progenitor and stem cells available and outlines their therapeutic application - Examines the basic principles for the culture of stem cells before discussing technologies for particular cell types, including human embryonic, induced pluripotent, amniotic and placental, cord and multipotent stem cells - Includes a discussion of wider issues such as intellectual property, regulation and commercialisation of stem cell technologies and therapies |
| allogeneic cell therapy companies: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy Mahmoud Aljurf, John A. Snowden, Patrick Hayden, Kim H. Orchard, Eoin McGrath, 2021-02-19 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. |
| allogeneic cell therapy companies: Allogeneic Stem Cell Transplantation Hillard M. Lazarus, Mary J. Laughlin, 2010-03-02 Since the original publication of Allogeneic Stem Cell Transplantation: Clinical Research and Practice, Allogeneic hematopoietic stem cell transplantation (HSC) has undergone several fast-paced changes. In this second edition, the editors have focused on topics relevant to evolving knowledge in the field in order to better guide clinicians in decision-making and management of their patients, as well as help lead laboratory investigators in new directions emanating from clinical observations. Some of the most respected clinicians and scientists in this discipline have responded to the recent advances in the field by providing state-of-the-art discussions addressing these topics in the second edition. The text covers the scope of human genomic variation, the methods of HLA typing and interpretation of high-resolution HLA results. Comprehensive and up-to-date, Allogeneic Stem Cell Transplantation: Clinical Research and Practice, Second Edition offers concise advice on today's best clinical practice and will be of significant benefit to all clinicians and researchers in allogeneic HSC transplantation. |
| allogeneic cell therapy companies: Therapy with Cultured Cells Howard Green, 2019-05-08 In this book the author describes the discoveries in his laboratory that led to therapy with cultured cells. The first cultured cell type used for therapy was the keratinocyte of the epidermis, for the treatment of burns. Subsequent developments led to the use of cultured cells for the treatment of diseases of the eye, of the joints and of other diseases. Cultured cells for therapy are now being prepared by industries in the US, Japan and Korea and are used in the aforesaid countries, as well as in France, Sweden and Greece, for the treatment of disease. |
| allogeneic cell therapy companies: Thomas' Hematopoietic Cell Transplantation Stephen J. Forman, Robert S. Negrin, Joseph H. Antin, Frederick R. Appelbaum, 2015-12-14 Fully revised for the fifth edition, this outstanding reference on bone marrow transplantation is an essential, field-leading resource. Extensive coverage of the field, from the scientific basis for stem-cell transplantation to the future direction of research Combines the knowledge and expertise of over 170 international specialists across 106 chapters Includes new chapters addressing basic science experiments in stem-cell biology, immunology, and tolerance Contains expanded content on the benefits and challenges of transplantation, and analysis of the impact of new therapies to help clinical decision-making Includes a fully searchable Wiley Digital Edition with downloadable figures, linked references, and more References for this new edition are online only, accessible via the Wiley Digital Edition code printed inside the front cover or at www.wiley.com/go/forman/hematopoietic. |
| allogeneic cell therapy companies: Non-Myeloablative Allogeneic Transplantation Asad Bashey, Edward D. Ball, 2002-02-28 Non-myeloablative allogeneic stem cell transplantation (also known as mini-transplantation or reduced-intensity conditioning transplantation) is a major advance in the field of hematopoietic transplantation within the last 5 years. This approach uses non-cytotoxic or reduced-intensity cytotoxic therapy to prepare patients for allografting of hematopoietic stem cells and lymphocytes. It has the potential to deliver the potent anti-tumor immunotherapy and bone marrow replacement capacity of allogeneic stem cell transplantation to patients with reduced treatment-related morbidity and mortality. It may also enable allogeneic transplantation in patients who would be considered ineligible for conventional transplants because of co-morbidity or advanced age. However, this approach may necessitate more careful monitoring of post-transplant chimerism and malignant disease-status than is usual with conventional allografting. There is also controversy regarding the best preparative regimen and graft-versus-host disease prophylaxis to use. |
| allogeneic cell therapy companies: The Business of Healthcare Innovation Lawton Robert Burns, 2005-08-25 The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants. |
| allogeneic cell therapy companies: EBMT HANDBOOK , 2025 |
| allogeneic cell therapy companies: Therapeutic Oligonucleotides Jens Kurreck, 2008 This book provides a compelling overall update on current status of RNA interference |
| allogeneic cell therapy companies: Hematopoietic Stem Cell Transplantation and Cellular Therapies for Autoimmune Diseases Richard K. Burt, Dominique Farge, Milton A. Ruiz, Riccardo Saccardi, John A. Snowden, 2021-11-17 This book summarizes the global progress in medical and scientific research toward converting traditionally chronic autoimmune diseases into a drug-free reversible illness using hematopoietic stem cell transplantation (HSCT) and other cellular therapies such as T regulatory cells (Treg), mesenchymal stromal/stem cells, and chimeric antigen receptor T (CAR T) cells in order to reintroduce sustained immune tolerance. This title provides information on different types of stem cells and immune cells; post-transplant immune regeneration; cellular regulatory requirements; ethical and economic considerations; and the advantages and disadvantages of HSCT in the treatment of a variety of autoimmune diseases versus current conventional treatments. Arranged by disease, the text provides a comprehensive guide to HSCT for all types of autoimmune/immune disorders including monogenetic autoimmune diseases; autoimmune aplastic anemia; neurologic immune diseases including multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, neuromyelitis optica, and stiff person syndrome; rheumatologic diseases such as systemic sclerosis and systemic lupus erythematosus; dermatologic diseases such as pemphigus; gastrointestinal disorders such as Crohn’s disease and celiac disease; and immune-mediated endocrinologic disease type I diabetes mellitus. Guidance is provided on the transplantation technique, cell collection and processing, conditioning regimens, infections, and early and late complications. Key Features Outlines therapies and techniques for HSCT for autoimmune diseases Discusses the advantages of HSCT over conventional therapies Reviews the entire process of stem cell therapy from harvest and ethics to indications, efficacy, and regulatory oversight |
| allogeneic cell therapy companies: Mesenchymal Stem Cell Therapy Lucas G. Chase, Mohan C Vemuri, 2012-12-12 Over the past decade, significant efforts have been made to develop stem cell-based therapies for difficult to treat diseases. Multipotent mesenchymal stromal cells, also referred to as mesenchymal stem cells (MSCs), appear to hold great promise in regards to a regenerative cell-based therapy for the treatment of these diseases. Currently, more than 200 clinical trials are underway worldwide exploring the use of MSCs for the treatment of a wide range of disorders including bone, cartilage and tendon damage, myocardial infarction, graft-versus-host disease, Crohn’s disease, diabetes, multiple sclerosis, critical limb ischemia and many others. MSCs were first identified by Friendenstein and colleagues as an adherent stromal cell population within the bone marrow with the ability to form clonogenic colonies in vitro. In regards to the basic biology associated with MSCs, there has been tremendous progress towards understanding this cell population’s phenotype and function from a range of tissue sources. Despite enormous progress and an overall increased understanding of MSCs at the molecular and cellular level, several critical questions remain to be answered in regards to the use of these cells in therapeutic applications. Clinically, both autologous and allogenic approaches for the transplantation of MSCs are being explored. Several of the processing steps needed for the clinical application of MSCs, including isolation from various tissues, scalable in vitro expansion, cell banking, dose preparation, quality control parameters, delivery methods and numerous others are being extensively studied. Despite a significant number of ongoing clinical trials, none of the current therapeutic approaches have, at this point, become a standard of care treatment. Although exceptionally promising, the clinical translation of MSC-based therapies is still a work in progress. The extensive number of ongoing clinical trials is expected to provide a clearer path forward for the realization and implementation of MSCs in regenerative medicine. Towards this end, reviews of current clinical trial results and discussions of relevant topics association with the clinical application of MSCs are compiled in this book from some of the leading researchers in this exciting and rapidly advancing field. Although not absolutely all-inclusive, we hope the chapters within this book can promote and enable a better understanding of the translation of MSCs from bench-to-bedside and inspire researchers to further explore this promising and quickly evolving field. |
| allogeneic cell therapy companies: Human Embryonic Stem Cells Arlene Chiu, Mahendra S. Rao, 2003-08 A discussion of all the key issues in the use of human pluripotent stem cells for treating degenerative diseases or for replacing tissues lost from trauma. On the practical side, the topics range from the problems of deriving human embryonic stem cells and driving their differentiation along specific lineages, regulating their development into mature cells, and bringing stem cell therapy to clinical trials. Regulatory issues are addressed in discussions of the ethical debate surrounding the derivation of human embryonic stem cells and the current policies governing their use in the United States and abroad, including the rules and conditions regulating federal funding and questions of intellectual property. |
| allogeneic cell therapy companies: Safety, Efficacy and Mechanisms of Action of Mesenchymal Stem Cell Therapies Guido Moll, Martin Johannes Hoogduijn, James A. Ankrum, 2020-07-24 |
| allogeneic cell therapy companies: Childhood Acute Lymphoblastic Leukemia Ajay Vora, 2017-04-21 This book provides a comprehensive and up-to-date review of all aspects of childhood Acute Lymphoblastic Leukemia, from basic biology to supportive care. It offers new insights into the genetic pre-disposition to the condition and discusses how response to early therapy and its basic biology are utilized to develop new prognostic stratification systems and target therapy. Readers will learn about current treatment and outcomes, such as immunotherapy and targeted therapy approaches. Supportive care and management of the condition in resource poor countries are also discussed in detail. This is an indispensable guide for research and laboratory scientists, pediatric hematologists as well as specialist nurses involved in the care of childhood leukemia. |
| allogeneic cell therapy companies: Translational Regenerative Medicine Anthony Atala, Julie Allickson, 2014-12-01 Translational Regenerative Medicine is a reference book that outlines the life cycle for effective implementation of discoveries in the dynamic field of regenerative medicine. By addressing science, technology, development, regulatory, manufacturing, intellectual property, investment, financial, and clinical aspects of the field, this work takes a holistic look at the translation of science and disseminates knowledge for practical use of regenerative medicine tools, therapeutics, and diagnostics. Incorporating contributions from leaders in the fields of translational science across academia, industry, and government, this book establishes a more fluid transition for rapid translation of research to enhance human health and well-being. - Provides formulaic coverage of the landscape, process development, manufacturing, challenges, evaluation, and regulatory aspects of the most promising regenerative medicine clinical applications - Covers clinical aspects of regenerative medicine related to skin, cartilage, tendons, ligaments, joints, bone, fat, muscle, vascular system, hematopoietic /immune system, peripheral nerve, central nervous system, endocrine system, ophthalmic system, auditory system, oral system, respiratory system, cardiac system, renal system, hepatic system, gastrointestinal system, genitourinary system - Identifies effective, proven tools and metrics to identify and pursue clinical and commercial regenerative medicine |
| allogeneic cell therapy companies: The EBMT/EHA CAR-T Cell Handbook Nicolaus Kröger, John Gribben, Christian Chabannon, Ibrahim Yakoub-Agha, Hermann Einsele, 2022-02-07 This first open access European CAR-T Handbook, co-promoted by the European Society for Blood and Marrow Transplantation (EBMT) and the European Hematology Association (EHA), covers several aspects of CAR-T cell treatments, including the underlying biology, indications, management of side-effects, access and manufacturing issues. This book, written by leading experts in the field to enhance readers’ knowledge and practice skills, provides an unparalleled overview of the CAR-T cell technology and its application in clinical care, to enhance readers’ knowledge and practice skills. |
| allogeneic cell therapy companies: Stem Cells Mariusz Z. Ratajczak, 2020-01-02 Since different types of stem cells for therapeutic applications have recently been proposed, this timely volume explores various sources of stem cells for tissue and organ regeneration and discusses their advantages and limitations. Also discussed are pros and cons for using embryonic stem cells, induced pluripotent stem cells, and adult stem cells isolated from postnatal tissues. Different types of adult stem cells for therapeutic applications are also reviewed, including hematopoietic stem cells, epidermal stem cells, endothelial progenitors, neural stem cells, mesenchymal stem cells, and very small embryonic-like stem cells. This book also addresses paracrine effects of stem cells in regenerative medicine that are mediated by extracellular microvesicles and soluble secretome. Finally, potential applications of stem cells in cardiology, gastroenterology, neurology, immunotherapy, and aging are presented. This is an ideal book for students and researchers working in the stem cell research field. |
| allogeneic cell therapy companies: Stem Cell Manufacturing Joaquim M.S. Cabral, Claudia Lobato da Silva, Lucas G. Chase, M. Margardia Diogo, 2016-07-24 Stem Cell Manufacturing discusses the required technologies that enable the transfer of the current laboratory-based practice of stem cell tissue culture to the clinic environment as therapeutics, while concurrently achieving control, reproducibility, automation, validation, and safety of the process and the product. The advent of stem cell research unveiled the therapeutic potential of stem cells and their derivatives and increased the awareness of the public and scientific community for the topic. The successful manufacturing of stem cells and their derivatives is expected to have a positive impact in the society since it will contribute to widen the offer of therapeutic solutions to the patients. Fully defined cellular products can be used to restore the structure and function of damaged tissues and organs and to develop stem cell-based cellular therapies for the treatment of cancer and hematological disorders, autoimmune and other inflammatory diseases and genetic disorders. - Presents the first 'Flowchart' of stem cell manufacturing enabling easy understanding of the various processes in a sequential and coherent manner - Covers all bioprocess technologies required for the transfer of the bench findings to the clinic including the process components: cell signals, bioreactors, modeling, automation, safety, etc. - Presents comprehensive coverage of a true multidisciplinary topic by bringing together specialists in their particular area - Provides the basics of the processes and identifies the issues to be resolved for large scale cell culture by the bioengineer - Addresses the critical need in bioprocessing for the successful delivery of stem cell technology to the market place by involving professional engineers in sections of the book |
| allogeneic cell therapy companies: Cell Therapy Adrian Gee, 2009-09-18 Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library. Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file. |
| allogeneic cell therapy companies: Rare Disease Drug Development Raymond A. Huml, 2021-11-08 This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers. |
| allogeneic cell therapy companies: Chimeric Antigen Receptor T-Cell Therapies for Cancer E-Book Daniel W. Lee, Nirali N. Shah, 2019-11-30 From patient referral to post-therapy management, Chimeric Antigen Receptor (CAR) T-Cell Therapies for Cancer: A Practical Guide presents a comprehensive view of CAR modified T-cells in a concise and practical format. Providing authoritative guidance on the implementation and management of CAR T-cell therapy from Drs. Daniel W. Lee and Nirali N. Shah, this clinical resource keeps you up to date on the latest developments in this rapidly evolving area. - Covers all clinical aspects, including patient referral, toxicities management, comorbidities, bridging therapy, post-CAR monitoring, and multidisciplinary approaches to supportive care. - Includes key topics on associated toxicities such as predictive biomarkers, infections, and multidisciplinary approaches to supportive care. - Presents current knowledge on FDA approved CAR T-cell products as well as developments on the horizon. - Editors and authors represent leading investigators in academia and worldwide pioneers of CAR therapy. |
| allogeneic cell therapy companies: Wound Healing Biomaterials - Volume 1 Magnus Ågren, 2016-06-03 Wound Healing Biomaterials: Volume One, Therapies and Regeneration discusses the types of wounds associated with trauma, illness, or surgery that can sometimes be extremely complex and difficult to heal. Consequently, there is a prominent drive for scientists and clinicians to find methods to heal these types of wounds, with science increasingly turning towards biomaterials to address these challenges. Much research is now concerned with new therapies, regeneration methods, and biomaterials to assist in wound healing and healing response. This book provides readers with a comprehensive review of the fundamentals and advances in the field of wound healing with regard to therapies and tissue regeneration. Chapters in Part One discuss fundamentals and strategies of wound healing, while Part Two reviews gene, stem cell, and drug delivery therapies for wound healing. Final chapters look at tissue regeneration strategies, making this an all-encompassing book on the topic of wound care and biomaterials. - Provides more systematic and comprehensive coverage of specific therapies and biomaterials for wound healing - Highlights research that is concerned with new therapies, regeneration methods, and the use of biomaterials to assist in wound healing and healing response - Presents an organized layout of the material that is carefully arranged with clear titles and comprehensive section headings - Looks at tissue regeneration strategies, making this an all encompassing book on the topic of wound care |
| allogeneic cell therapy companies: Chronic Graft Versus Host Disease Georgia B. Vogelsang, Steven Z. Pavletic, 2009-04-20 Chronic graft versus host disease (GVHD) is the most common complication of allogenic bone marrow transplantation. Because of the protracted clinical course of chronic GVHD, transplant centers and hematology/oncology offices are inadequately equipped to manage these immuno-incompetent patients with a multi-system disorder. Practitioners need to be able to recognize and effectively manage chronic GVHD as a late effect of more than half of allogenic transplantations. The text is oriented for the clinician, with chapters covering staging, organ site and system-specific manifestations, treatment options, and supportive care. Drs Georgia B. Vogelsang and Steven Z. Pavletic have been pioneers in the recognition of the multi-organ complexity of this disease and have gathered the input of a variety of subspecialist physicians for this book. This book fills the gap in practical literature on chronic GVHD, providing a comprehensive, up-to-date, and clinically relevant resource for anyone who deals with cancer patients post-transplant. |
| allogeneic cell therapy companies: Living Donor Transplantation Henkie P. Tan, Amadeo Marcos, Ron Shapiro, 2007-04-27 Edited by leaders at one of the acclaimed transplant institutions in the United States, this reference covers all aspects of living donor solid organ and cellular transplantation in current clinical practice, including the kidney, liver, pancreas, lung, small bowel, islet, and hematopoietic stem cell transplantation. Detailed, engaging, and organ- |
| allogeneic cell therapy companies: Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies OECD, World Health Organization, 2019-10-17 This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies. |
| allogeneic cell therapy companies: Methods of Tissue Engineering Anthony Atala, Robert Lanza, 2001-10-12 This reference book combines the tools, experimental protocols, detailed descriptions and know-how for the successful engineering of tissues and organs in one volume. |
| allogeneic cell therapy companies: Second Generation Cell and Gene-Based Therapies Alain Vertes, Nathan J. Dowden, Devyn Smith, Nasib Qureshi, 2020-02-07 Second Generation Cell and Gene-Based Therapies: Biological Advances, Clinical Outcomes, and Strategies for Capitalisation serves as the only volume to the market to bridge basic science, clinical therapy, technology development, and business in the field of cellular therapy/cytotherapy. After more than two decades of painstaking fundamental research, the concept of therapeutic cells (stem cells, genes, etc.), beyond the concept of vaccines, is reaching clinical trial, with mounting confidence in the safety and efficacy of these products. Nonetheless, numerous incremental technical advances remain to be achieved. Thus, this volume highlights the possible R&D paths, which will ultimately facilitate clinical delivery of cutting edge curative products.The next waves of innovation are reviewed in depth for hematopoietic stem cells, mesenchymal stem cells, tissue engineering, CAR-T cells, and cells of the immune system, as well as for enabling technologies such as gene and genome editing. Additionally, deep dives in product fundamentals, history of science, pathobiology of diseases, scientific and technological bases, and financing and technology adoption constraints are taken to unravel what will shape the cytotherapy industry to the horizon 2025 and beyond. The outcome is not simply a scientific book, but a global perspective on the nascent field combining science, business, and strategic fundamentals. - Helps readers learn about the most current trends in cell-based therapy, their overall effectiveness from a clinical prospective, and how the industry is moving therapies forward for capitalization - Perspectives section at the end of each chapter summarizes key learnings, hypotheses, and objectives highlighted and combines scientific and business insights - Edited and authored by scientists representing both basic and clinical research and industry, presenting a complete story of the current state and future promise of cellular therapies |
| allogeneic cell therapy companies: Bioprocessing for Cell-Based Therapies Che J. Connon, 2017-02-06 With contributions from leading, international academics and industrial practitioners, Bioprocessing for Cell-Based Therapies explores the very latest techniques and guidelines in bioprocess production to meet safety, regulatory and ethical requirements, for the production of therapeutic cells, including stem cells. An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout In depth discussion of the application of cell therapy including methods used in the delivery of cells to the patient Includes contributions from experts in both academia and industry, combining a practical approach with cutting edge research The only handbook currently available to provide a state of the art guide to Bioprocessing covering the complete range of cell-based therapies, from experts in academia and industry |
| allogeneic cell therapy companies: Aplastic Anemia Hubert Schrezenmeier, Andrea Bacigalupo, 2000 Comprehensive and up-to-date clinical reference, with an emphasis on treatment. |
| allogeneic cell therapy companies: Epstein Barr Virus Volume 2 Christian Münz, 2015-10-01 Epstein Barr virus (EBV) was discovered as the first human tumor virus around 50 years ago. Since its discovery in Burkitt’s lymphoma it has been associated with various other malignancies, infectious mononucleosis and even autoimmune diseases. The two book volumes on EBV summarize the first 50 years of research on this tumor virus, starting with historical perspectives on discovery, oncogenicity and immune control, reviewing the role that the virus plays in the various associated diseases and concluding with a discussion on how the immune system keeps persistent EBV infection under control in healthy EBV carriers and can be used to treat EBV associated diseases. The respective 32 chapters are written by international experts from three continents for health care providers, biomedical researchers and patients that are affected by EBV. The assembled knowledge should help to understand EBV associated diseases better and to develop EBV specific vaccination in the near future. |
| allogeneic cell therapy companies: Guidelines for Preparing Patent Landscape Reports World Intellectual Property Organization, 2015-08-24 These Guidelines are designed both for general users of patent information, as well as for those involved in producing Patent Landscape Reports (PLRs). They provide step-by-step instructions on how to prepare a PLR, as well as background information such as objectives, patent analytics, concepts and frameworks. |
| allogeneic cell therapy companies: Curing Genetic Diseases through Genome Reprogramming , 2021-06-24 Curing Genetic Diseases through Genome Reprogramming, Volume 182 captures an historic moment in the field of gene therapy—the dawn of a new age in which the dream of curing genetic diseases has become realizable. The volume presents the most clinically advanced gene therapy and genome editing approaches for the treatment of genetic diseases in specific organs, including difficult therapeutic targets, futuristic ideas of genetic interventions, and large scale human genome repair. An initial chapter addresses the complex ethical aspects involved in the very idea of modifying the human genome. - Provides a comprehensive view of gene therapy and genome editing technologies, including epigenetic editing - Describes the state-of-the-art and future directions for the treatment of genetic diseases, also considering economical aspects - Presents chapters that each give a thorough review of a specific disease, target organ or visionary approach, including ethical considerations |
| allogeneic cell therapy companies: Human Pluripotent Stem Cells Philip H. Schwartz, Robin L. Wesselschmidt, 2011-08-09 Almost daily, new technologies are being presented that move the field of human pluripotent stem cell research towards a future that may yield highly-effective, personalized medical treatments. Three enabling technologies at hand for human PSCs are 1) directed reprogramming of somatic cells, which eliminate many of the ethical issues associated with the derivation and use of human PSCs, increase genetic diversity of the available human PSC lines, and give rise to better in vitro human disease models; 2) the discovery that a Rho-associated protein Kinase (ROCK) inhibitor allows for efficient single cell passaging and cryopreservation, increasing the efficiency and reliability of hPSC culture; and 3) defined, animal-component-free media, which lay the groundwork for simplified scale-up for therapeutic applications, differentiation protocols, and toxicology screens. The aforementioned technologies can be found in Human Pluripotent Stem Cells: Methods and Protocols, a compilation of 33 detailed protocols in six categories of PSC research that cover laboratory essentials and the derivation of new PSC lines, including induced PSC lines, as well as their growth, maintenance, characterization, genetic manipulation, and differentiation. Written in the successful Methods in Molecular BiologyTM series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and accessible, Human Pluripotent Stem Cells: Methods and Protocols serves as an ideal guide to scientists conducting their own pluripotent cell research programs and makes great strides towards furthering human knowledge and, ultimately, improving the human condition. |
| allogeneic cell therapy companies: Extracellular Matrix-derived Implants in Clinical Medicine Daniel Mooradian, 2016-05-23 Extracellular Matrix-Derived Implants in Clinical Medicine comprehensively covers the emergence of tissue engineering and regenerative medicine over the past few decades, along with discussions of continuous funding and research. The book provides a state-of-the-art review of this increasingly important technology and how it is translating from bench to bedside. Part One of the book looks at the historical use of human and animal tissues, focusing on the main application areas, including cardiovascular, hard and soft tissue engineering, and neurological, while Part Two examines the challenges in harvesting, processing, and manufacturing of extracellular matrices, with a final section reviewing the international regulatory environment and economics of tissue-based products. |
Allogeneic Stem Cell Transplant: Procedure & Recovery - Cleveland Clinic
Mar 24, 2025 · An allogeneic stem cell transplant is treatment for certain blood cancers and blood disorders. It uses donated healthy stem cells to replace unhealthy stem cells.
Allogeneic stem cell transplant - Type - Mayo Clinic
Jan 31, 2025 · An allogeneic stem cell transplant uses healthy blood stem cells from a donor to replace bone marrow that's not producing enough healthy blood cells. An allogeneic stem cell …
Allogeneic vs. Autologous Stem Cell Transplant: What Is the …
May 14, 2021 · There are two types of stem cell transplants used to treat leukemia, allogeneic and autologous. In an allogeneic stem cell transplant, stem cells come from a donor. In an autologous …
ALLOGENEIC Definition & Meaning - Merriam-Webster
The meaning of ALLOGENEIC is involving, derived from, or being individuals of the same species that are sufficiently unlike genetically to interact antigenically. How to use allogeneic in a sentence.
Allotransplantation - Wikipedia
Allotransplant (allo- meaning "other" in Greek) is the transplantation of cells, tissues, or organs to a recipient from a genetically non-identical donor of the same species. [1] . The transplant is called …
Allogeneic Stem Cell Transplant: A Guide for Patients
Sep 3, 2024 · Understanding Your Allogeneic Stem Cell Transplant. When you have an allogeneic stem cell transplant, stem cells are harvested (collected) from a donor. “Allogeneic” means that …
Types of Stem Cell and Bone Marrow Transplants
Learn more about different types of stem cell transplants, including autologous and allogeneic transplants, and the pros and cons of each.
Autologous vs. Allogeneic Stem Cell Transplants: What’s the …
Mar 6, 2017 · Autologous vs. Allogeneic Stem Cell Transplants: What’s the Difference? An autologous transplant uses a person’s own stem cells. An allogeneic transplant uses stem cells …
Stem Cell Transplantation | Allogeneic Stem Cell Transplantation …
Allogeneic SCT is often used to treat blood cancers such as leukemia, myelodysplastic syndromes and myeloproliferative neoplasms. Once it is determined that allogeneic SCT is a treatment …
Allogeneic | definition of allogeneic by Medical dictionary
allogeneic adjective Referring to genetic differences among individuals of the same species. Two or more individuals are said to be allogeneic when the genes at one or more loci are not identical in …
Allogeneic Stem Cell Transplant: Procedure & Recovery - Cleveland Clinic
Mar 24, 2025 · An allogeneic stem cell transplant is treatment for certain blood cancers and blood disorders. It uses donated healthy stem cells to replace unhealthy stem cells.
Allogeneic stem cell transplant - Type - Mayo Clinic
Jan 31, 2025 · An allogeneic stem cell transplant uses healthy blood stem cells from a donor to replace bone marrow that's not producing enough healthy blood cells. An allogeneic stem cell …
Allogeneic vs. Autologous Stem Cell Transplant: What Is the …
May 14, 2021 · There are two types of stem cell transplants used to treat leukemia, allogeneic and autologous. In an allogeneic stem cell transplant, stem cells come from a donor. In an …
ALLOGENEIC Definition & Meaning - Merriam-Webster
The meaning of ALLOGENEIC is involving, derived from, or being individuals of the same species that are sufficiently unlike genetically to interact antigenically. How to use allogeneic in a …
Allotransplantation - Wikipedia
Allotransplant (allo- meaning "other" in Greek) is the transplantation of cells, tissues, or organs to a recipient from a genetically non-identical donor of the same species. [1] . The transplant is …
Allogeneic Stem Cell Transplant: A Guide for Patients & Caregivers
Sep 3, 2024 · Understanding Your Allogeneic Stem Cell Transplant. When you have an allogeneic stem cell transplant, stem cells are harvested (collected) from a donor. “Allogeneic” means …
Types of Stem Cell and Bone Marrow Transplants
Learn more about different types of stem cell transplants, including autologous and allogeneic transplants, and the pros and cons of each.
Autologous vs. Allogeneic Stem Cell Transplants: What’s the …
Mar 6, 2017 · Autologous vs. Allogeneic Stem Cell Transplants: What’s the Difference? An autologous transplant uses a person’s own stem cells. An allogeneic transplant uses stem …
Stem Cell Transplantation | Allogeneic Stem Cell Transplantation …
Allogeneic SCT is often used to treat blood cancers such as leukemia, myelodysplastic syndromes and myeloproliferative neoplasms. Once it is determined that allogeneic SCT is a …
Allogeneic | definition of allogeneic by Medical dictionary
allogeneic adjective Referring to genetic differences among individuals of the same species. Two or more individuals are said to be allogeneic when the genes at one or more loci are not …
