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The Emerging Role of Exosome Nanoparticles in Regenerative Medicine
Published in Harishkumar Madhyastha, Durgesh Nandini Chauhan, Nanopharmaceuticals in Regenerative Medicine, 2022
Zahra Sadat Hashemi, Mahlegha Ghavami, Saeed Khalili, Seyed Morteza Naghib
Stem cells are undifferentiated cells that could differentiate into specialised cell types (potency) and proliferate indefinitely with numerous cell growth cycles (self-renewal) (Hashemi et al. 2015; Hashemi et al. 2013; Molaabasi et al. 2020; Ghorbanzade et al. 2020). The use of stem cells is a highly established approach in regenerative medicine (Askari and Naghib 2020; Ghorbanzade and Naghib 2019). For instance, Embryonic Stem Cells (ESCs) can differentiate into more than 200 types of cells which could be used to restore a patient’s tissue from severe injuries or chronic diseases (Mahla 2016). The application of regenerative medicine could encompass the cell therapy (using the patient’s own cells or non-native donor cells), treatment with growth factors, applications of recombinant proteins, small molecules, and finally tissue engineering and gene therapy. The cell therapy method could be defined as the introduction of new cells into the tissue for disease treatment. These new cells often focus on the stem cells or mature, functional cells with or without genetic modification (gene therapy) for both kinds of cells (Wei et al. 2013).
Cellular Therapeutics: A Novel Modality with Great Therapeutic Potential
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Cell therapy is defined as the administration of live whole cells or maturation of a specific cell population in a patient for the treatment of a disease. There is a distinct difference between this approach versus organ transplantation, which transfers whole organs from one subject to another. However, if organs can be grown ex vivo in the future starting with cells, this definition may be revised. In fact, there are certain types of tissues, such as skin, that can be artificially created beginning with cells (Organogenesis, Inc. markets such a product), so the line between cellular therapies and tissue/organ therapeutics is already becoming blurred. There are very specific regulatory definitions of what a cellular therapy is, and this affects which regulatory agencies review dossiers. For example, administration of chimeric antigen receptor T (CART) cells that are genetically modified are considered gene therapies and, as such, administered through the Office of Tissue and Advanced Therapies in the United States. As cell therapies continue to advance, there have been specific guidance documents created with more clarity regarding the requirements for these therapies.
A calibration-free method for biosensing in cell manufacturing
Published in IISE Transactions, 2021
Jialei Chen, Zhaonan Liu, Kan Wang, Chen Jiang, Chuck Zhang, Ben Wang
Cell therapy is one of the most promising treatment approaches to have emerged over the last decades, demonstrating great potential in treating cancers, including leukemia and lymphoma (Kim and de Vellis, 2009; Yin, 2017). Among those therapies, Chimeric Antigen Receptor (CAR) T-cell therapy (Bonifant et al., 2016; June et al., 2018), involving the reprogramming of a patient’s T cells to effectively target and attack tumor cells, has shown innovative therapeutic effects in clinical trials, leading to a recent approval (i.e., the treatment of CD19+ hematological malignancies, see Prasad (2018)) by the FDA as a new cancer treatment modality. As illustrated in Figure 1, a typical CAR T-cell therapy involves four steps: deriving cells from a patient, genetically modifying the cells, culturing the cells, and re-administering back to the patient. With increasingly mature gene modification technology, more and more researchers focus on the culturing step (i.e., the red box in Figure 1), where the goal is to substantially increase the cell amount from a small batch to one dose for delivery to the patient. However, a key challenge is the intrinsic patient-to-patient variability in the starting material, i.e., cells derived from different patients vary in their viabilities, acceptance rates of genetic modification, and reactions to culture media (Hinrichs and Restifo, 2013). These variabilities introduce difficulties in cell culturing scale-up (i.e., cell manufacturing), and therefore, the current CAR T-cell therapy is hindered by low scalability, labor-intensive processes, and extremely high cost (Harrison et al., 2019). To achieve high quality and acceptable vein-to-vein cost, we present in this work a statistical framework for online monitoring in cell manufacturing, which can alleviate the negative effect of the intrinsic patient-to-patient variability.