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Biosafety assessment of site-directed transgene integration in human umbilical cord-lining cells.


ABSTRACT: Biosafety and efficacy considerations that impede clinical application of gene therapy could be addressed by nonviral ex vivo cell therapy, utilizing transgenic cells that have been comprehensively pre-evaluated for genotoxic potential and transgene expression. We evaluated the genotoxic potential of phiC31 bacteriophage integrase-mediated transgene integration in cord-lining epithelial cells (CLECs) readily cultured from the outer membrane of human umbilical cords, by sequencing and mapping integration sites, spectral karyotyping, high-resolution genome copy number, transcriptome, and transgene copy number analyses and in vivo tumorigenicity. Of 44 independent integration events, <5% were exonic and 85% of modified cells had integrated

SUBMITTER: Sivalingam J 

PROVIDER: S-EPMC2911251 | biostudies-literature | 2010 Jul

REPOSITORIES: biostudies-literature

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Biosafety assessment of site-directed transgene integration in human umbilical cord-lining cells.

Sivalingam Jaichandran J   Krishnan Shruti S   Ng Wai Har WH   Lee Sze Sing SS   Phan Toan Thang TT   Kon Oi Lian OL  

Molecular therapy : the journal of the American Society of Gene Therapy 20100427 7


Biosafety and efficacy considerations that impede clinical application of gene therapy could be addressed by nonviral ex vivo cell therapy, utilizing transgenic cells that have been comprehensively pre-evaluated for genotoxic potential and transgene expression. We evaluated the genotoxic potential of phiC31 bacteriophage integrase-mediated transgene integration in cord-lining epithelial cells (CLECs) readily cultured from the outer membrane of human umbilical cords, by sequencing and mapping int  ...[more]

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