Literature DB >> 27876286

Clinical Trials in a Dish.

David G Strauss1, Ksenia Blinova2.   

Abstract

Clinical trials 'in a dish' involve testing medical therapies for safety or effectiveness in the laboratory with human tissue. This has become possible owing to recent biotechnology advances including induced pluripotent stem cells, organs-on-a-chip, and whole-genome sequencing. We provide here an overview of the landscape and highlight steps the FDA is taking to advance the science of clinical trials in a dish and to support the development and validation of new regulatory paradigms to assess drug safety using these new technologies. Published by Elsevier Ltd.

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Year:  2016        PMID： 27876286      PMCID： PMC5379998          DOI： 10.1016/j.tips.2016.10.009

Source DB:  PubMed          Journal:  Trends Pharmacol Sci        ISSN： 0165-6147            Impact factor:   14.819


  11 in total

Review 1.  Induced pluripotent stem cells--opportunities for disease modelling and drug discovery.

Authors:  Marica Grskovic; Ashkan Javaherian; Berta Strulovici; George Q Daley
Journal:  Nat Rev Drug Discov       Date:  2011-11-11       Impact factor: 84.694

2.  The Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative - Update on progress.

Authors:  Thomas Colatsky; Bernard Fermini; Gary Gintant; Jennifer B Pierson; Philip Sager; Yuko Sekino; David G Strauss; Norman Stockbridge
Journal:  J Pharmacol Toxicol Methods       Date:  2016-06-07       Impact factor: 1.950

3.  Human induced pluripotent stem cell-derived cardiomyocytes recapitulate the predilection of breast cancer patients to doxorubicin-induced cardiotoxicity.

Authors:  Paul W Burridge; Yong Fuga Li; Elena Matsa; Haodi Wu; Sang-Ging Ong; Arun Sharma; Alexandra Holmström; Alex C Chang; Michael J Coronado; Antje D Ebert; Joshua W Knowles; Melinda L Telli; Ronald M Witteles; Helen M Blau; Daniel Bernstein; Russ B Altman; Joseph C Wu
Journal:  Nat Med       Date:  2016-04-18       Impact factor: 53.440

4.  Modeling host interactions with hepatitis B virus using primary and induced pluripotent stem cell-derived hepatocellular systems.

Authors:  Amir Shlomai; Robert E Schwartz; Vyas Ramanan; Ankit Bhatta; Ype P de Jong; Sangeeta N Bhatia; Charles M Rice
Journal:  Proc Natl Acad Sci U S A       Date:  2014-08-04       Impact factor: 11.205

5.  Late sodium current block for drug-induced long QT syndrome: Results from a prospective clinical trial.

Authors:  L Johannesen; J Vicente; J W Mason; C Erato; C Sanabria; K Waite-Labott; M Hong; J Lin; P Guo; A Mutlib; J Wang; W J Crumb; K Blinova; D Chan; J Stohlman; J Florian; M Ugander; N Stockbridge; D G Strauss
Journal:  Clin Pharmacol Ther       Date:  2015-11-28       Impact factor: 6.875

6.  Genome editing of isogenic human induced pluripotent stem cells recapitulates long QT phenotype for drug testing.

Authors:  Yongming Wang; Ping Liang; Feng Lan; Haodi Wu; Leszek Lisowski; Mingxia Gu; Shijun Hu; Mark A Kay; Fyodor D Urnov; Rami Shinnawi; Joseph D Gold; Lior Gepstein; Joseph C Wu
Journal:  J Am Coll Cardiol       Date:  2014-08-05       Impact factor: 24.094

7.  Human induced pluripotent stem cell-derived cardiomyocytes as an in vitro model for coxsackievirus B3-induced myocarditis and antiviral drug screening platform.

Authors:  Arun Sharma; Caleb Marceau; Ryoko Hamaguchi; Paul W Burridge; Kuppusamy Rajarajan; Jared M Churko; Haodi Wu; Karim I Sallam; Elena Matsa; Anthony C Sturzu; Yonglu Che; Antje Ebert; Sebastian Diecke; Ping Liang; Kristy Red-Horse; Jan E Carette; Sean M Wu; Joseph C Wu
Journal:  Circ Res       Date:  2014-07-11       Impact factor: 17.367

8.  Approaching the in vitro clinical trial: engineering organs on chips.

Authors:  A K Capulli; K Tian; N Mehandru; A Bukhta; S F Choudhury; M Suchyta; K K Parker
Journal:  Lab Chip       Date:  2014-09-07       Impact factor: 6.799

9.  Human iPSC-derived hepatocyte-like cells support Plasmodium liver-stage infection in vitro.

Authors:  Shengyong Ng; Robert E Schwartz; Sandra March; Ani Galstian; Nil Gural; Jing Shan; Mythili Prabhu; Maria M Mota; Sangeeta N Bhatia
Journal:  Stem Cell Reports       Date:  2015-02-07       Impact factor: 7.765

Review 10.  Site-Specific Genome Engineering in Human Pluripotent Stem Cells.

Authors:  Sylvia Merkert; Ulrich Martin
Journal:  Int J Mol Sci       Date:  2016-06-24       Impact factor: 5.923
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  12 in total

Review 1.  Zebrafish patient avatars in cancer biology and precision cancer therapy.

Authors:  Maurizio Fazio; Julien Ablain; Yan Chuan; David M Langenau; Leonard I Zon
Journal:  Nat Rev Cancer       Date:  2020-04-06       Impact factor: 60.716

Review 2.  Precision Medicine in Head and Neck Cancers: Genomic and Preclinical Approaches.

Authors:  Giacomo Miserocchi; Chiara Spadazzi; Sebastiano Calpona; Francesco De Rosa; Alice Usai; Alessandro De Vita; Chiara Liverani; Claudia Cocchi; Silvia Vanni; Chiara Calabrese; Massimo Bassi; Giovanni De Luca; Giuseppe Meccariello; Toni Ibrahim; Marco Schiavone; Laura Mercatali
Journal:  J Pers Med       Date:  2022-05-24

3.  Microfluidics-enabled 96-well perfusion system for high-throughput tissue engineering and long-term all-optical electrophysiology.

Authors:  Lai Wei; Weizhen Li; Emilia Entcheva; Zhenyu Li
Journal:  Lab Chip       Date:  2020-09-30       Impact factor: 6.799

4.  Translating New Science Into the Drug Review Process: The US FDA's Division of Applied Regulatory Science.

Authors:  Rodney Rouse; Naomi Kruhlak; James Weaver; Keith Burkhart; Vikram Patel; David G Strauss
Journal:  Ther Innov Regul Sci       Date:  2017-07-21       Impact factor: 1.778

5.  "Thorough QT/QTc in a Dish": Can Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes Predict Thorough QT Outcomes?

Authors:  Hugo M Vargas
Journal:  Clin Pharmacol Ther       Date:  2019-03-07       Impact factor: 6.875

Review 6.  Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the "CiPA" Initiative and Design of a Prospective Clinical Validation Study.

Authors:  Jose Vicente; Robbert Zusterzeel; Lars Johannesen; Jay Mason; Philip Sager; Vikram Patel; Murali K Matta; Zhihua Li; Jiang Liu; Christine Garnett; Norman Stockbridge; Issam Zineh; David G Strauss
Journal:  Clin Pharmacol Ther       Date:  2017-11-16       Impact factor: 6.875

Review 7.  Recent advances in understanding and prevention of sudden cardiac death.

Authors:  Jamie I Vandenberg; Matthew D Perry; Adam P Hill
Journal:  F1000Res       Date:  2017-08-31

8.  A Multiwell Cardiac μGMEA Platform for Action Potential Recordings from Human iPSC-Derived Cardiomyocyte Constructs.

Authors:  Stacie L Edwards; Viviana Zlochiver; Donald B Conrad; Ravi Vaidyanathan; Andrew M Valiquette; Rosy Joshi-Mukherjee
Journal:  Stem Cell Reports       Date:  2018-07-19       Impact factor: 7.765

Review 9.  The Emergence of Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes (hiPSC-CMs) as a Platform to Model Arrhythmogenic Diseases.

Authors:  Marc Pourrier; David Fedida
Journal:  Int J Mol Sci       Date:  2020-01-19       Impact factor: 5.923

Review 10.  CFTR Modulators: The Changing Face of Cystic Fibrosis in the Era of Precision Medicine.

Authors:  Miquéias Lopes-Pacheco
Journal:  Front Pharmacol       Date:  2020-02-21       Impact factor: 5.810
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