Tumorigenicity assessment of cell therapy products: the need for global consensus and points to consider.
Sign Up to like & getrecommendations! Published in 2019 at "Cytotherapy"
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.
Sign Up to like & getrecommendations! Published in 2021 at "Cytotherapy"
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.
Sign Up to like & getrecommendations! Published in 2021 at "Cytotherapy"
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
Mitochondrial DNA as a target for analyzing the biodistribution of cell therapy products
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DOI: 10.1038/s41598-024-56591-4
Abstract: Biodistribution tests are crucial for evaluating the safety of cell therapy (CT) products in order to prevent unwanted organ homing of these products in patients. Quantitative polymerase chain reaction (qPCR) using intronic Alu is a… read more here.
Keywords: cell therapy; therapy products; mitochondrial dna; biodistribution ... See more keywords
Emerging gene therapy products for RPGR-associated X-linked retinitis pigmentosa
Sign Up to like & getrecommendations! Published in 2022 at "Expert Opinion on Emerging Drugs"
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’
Sign Up to like & getrecommendations! Published in 2022 at "Expert Opinion on Emerging Drugs"
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
Sign Up to like & getrecommendations! Published in 2023 at "Journal of Clinical Microbiology"
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
Challenges of Cell Counting in Cell Therapy Products
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DOI: 10.1177/09636897241293628
Abstract: Cell counting is a common and fundamental cell measurement technique that plays a crucial role in the development and quality control of cell therapy products. However, accurate and reliable cell counting can be challenging owing… read more here.
Keywords: cell therapy; cell counting; therapy products; cell ... See more keywords
An In Vitro RNA Editing-Based Reporter Assay for Transcriptional Activity of Therapeutic Gene in Gene Therapy Products
Sign Up to like & getrecommendations! Published in 2024 at "Molecules"
DOI: 10.3390/molecules29225312
Abstract: The expression of therapeutic genes is critical for the efficacy of gene therapy products. However, existing methods such as immunological analysis at the protein level or reverse-transcription PCR at the RNA level are unable to… read more here.
Keywords: reporter assay; gene; therapy products; gene therapy ... See more keywords