Tumorigenicity assessment of cell therapy products: the need for global consensus and points to consider.
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DOI: 10.1016/j.jcyt.2019.10.001
Abstract: Pluripotent stem cells offer the potential for an unlimited source for cell therapy products. However, there is concern regarding the tumorigenicity of these products in humans, mainly due to the possible unintended contamination of undifferentiated… read more here.
Keywords: cell therapy; assessment cell; therapy products; tumorigenicity ... See more keywords
Management of externally manufactured cell therapy products: the Mayo Clinic approach.
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DOI: 10.1016/j.jcyt.2020.12.013
Abstract: BACKGROUND The rise of investigative and commercially available cell therapy products adds a new dynamic to academic medical centers; that is, the management of patient-specific cell products. The scope of cell therapy has rapidly expanded… read more here.
Keywords: externally manufactured; therapy products; cell; mayo clinic ... See more keywords
Accommodating clinical trials and other externally manufactured cellular therapy products: challenges, lessons learned and creative solutions.
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DOI: 10.1016/j.jcyt.2021.04.005
Abstract: BACKGROUND AIMS The Division of Transfusion Medicine and Cellular Therapy at New York-Presbyterian/Columbia University Irving Medical Center (NYPH-CUIMC) comprises the immunohematology laboratory and blood bank (transfusion service), hemotherapy/apheresis and the cellular therapy laboratory (CTL). The… read more here.
Keywords: clinical trials; lessons learned; therapy products; therapy ... See more keywords
Delivering externally manufactured cell and gene therapy products to patients: perspectives from the academic center experience.
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DOI: 10.1016/j.jcyt.2021.09.010
Abstract: The recent success of the commercialization of CAR-T and other immune effector cells has led to the rapid expansion of clinical trials using cellular therapy products. The expansion of both investigational and commercially available cell… read more here.
Keywords: center; externally manufactured; therapy products; therapy ... See more keywords
Emerging gene therapy products for RPGR-associated X-linked retinitis pigmentosa
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DOI: 10.1080/14728214.2022.2152003
Abstract: ABSTRACT Introduction Mutations in the RPGR gene are responsible for one of the most prevalent and severe types of retinitis pigmentosa. Gene therapy has shown great promise to treat inherited retinal diseases, and currently, four… read more here.
Keywords: rpgr; retinitis pigmentosa; gene therapy; therapy products ... See more keywords
Letter to the editor: ‘Emerging gene therapy products for RPGR-associated X-linked retinitis pigmentosa’
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DOI: 10.1080/14728214.2022.2152202
Abstract: This letter is to comment on the review article ‘Emerging gene therapy products on RPGR-associated retinitis pigmentosa’ by Martinez-Fernandez de la Camara and colleagues published in this issue of Expert Opinion On Emerging Drugs [1].… read more here.
Keywords: gene therapy; products rpgr; therapy products; gene ... See more keywords
Comparison of Five Commercial Molecular Assays for Mycoplasma Testing of Cellular Therapy Products
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DOI: 10.1128/jcm.01498-22
Abstract: Testing of cellular therapy products for Mycoplasma is a regulatory requirement by the United States Food and Drug Administration (FDA) to ensure the sterility and safety of the product prior to release for patient infusion.… read more here.
Keywords: cellular therapy; testing cellular; therapy products; commercial molecular ... See more keywords