期刊
MOLECULAR THERAPY-METHODS & CLINICAL DEVELOPMENT
卷 10, 期 -, 页码 371-378出版社
CELL PRESS
DOI: 10.1016/j.omtm.2018.08.006
关键词
-
资金
- NHLBI [P40HL116242]
- NCI
- NIH/NCI [P30 CA008748]
- NIH [P01CA190174-01A1A, R01CA114218, P50-CA190991, R01-CA177476]
- St. Baldrick's Foundation
- William Lawrence and Blanche Hughes Foundation
- Carson Family Charitable Trust
- Annual Terry Fox Run for Cancer Research
- NCI [PO1 CA008748, PO1 CA008748-T]
- NATIONAL CANCER INSTITUTE [P01CA190174, R01CA177476, P50CA190991, R01CA114218, ZIABC011334, P30CA008748] Funding Source: NIH RePORTER
- NATIONAL HEART, LUNG, AND BLOOD INSTITUTE [P40HL116242] Funding Source: NIH RePORTER
Replication-competent retrovirus (RCR) is a safety concern for individuals treated with retroviral gene therapy. RCR detection assays are used to detect RCR in manufactured vector, transduced cell products infused into research subjects, and in the research subjects after treatment. In this study, we reviewed 286 control (n = 4) and transduced cell products (n = 282) screened for RCR in the National Gene Vector Bio-repository. The transduced cell samples were submitted from 14 clinical trials. All vector products were previously shown to be negative for RCR prior to use in cell transduction. After transduction, all 282 transduced cell products were negative for RCR. In addition, 241 of the clinical trial participants were also screened for RCR by analyzing peripheral blood at least 1 month after infusion, all of which were also negative for evidence of RCR infection. The majority of vector products used in the clinical trials were generated in the PG13 packaging cell line. The findings suggest that screening of the retroviral vector product generated in PG13 cell line may be sufficient and that further screening of transduced cells does not provide added value.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据