Ontology highlight
ABSTRACT:
SUBMITTER: Balcerek J
PROVIDER: S-EPMC8636860 | biostudies-literature | 2021
REPOSITORIES: biostudies-literature
Balcerek Joanna J Shy Brian R BR Putnam Amy L AL Masiello Lisa M LM Lares Angela A Dekovic Florinna F Acevedo Luis L Lee Michael R MR Nguyen Vinh V Liu Weihong W Paruthiyil Sreenivasan S Xu Jingying J Leinbach Ashley S AS Bluestone Jeffrey A JA Tang Qizhi Q Esensten Jonathan H JH
Frontiers in immunology 20211118
We report on manufacturing outcomes for 41 autologous polyclonal regulatory T cell (PolyTreg) products for 7 different Phase 1 clinical trials over a 10-year period (2011-2020). Data on patient characteristics, manufacturing parameters, and manufacturing outcomes were collected from manufacturing batch records and entered into a secure database. Overall, 88% (36/41) of PolyTreg products met release criteria and 83% (34/41) of products were successfully infused into patients. Of the 7 not infused ...[more]