Literature DB >> 22932219

FDA oversight of cell therapy clinical trials.

Patrick Au1, Deborah A Hursh, Agnes Lim, Malcolm C Moos, Steven S Oh, Bruce S Schneider, Celia M Witten.   

Abstract

The U.S. Food and Drug Administration applies regulatory flexibility to balance benefits and risks to subjects in cell-therapy clinical trials.

Mesh：

Year:  2012        PMID： 22932219     DOI： 10.1126/scitranslmed.3004131

Source DB:  PubMed          Journal:  Sci Transl Med        ISSN： 1946-6234            Impact factor:   17.956


  15 in total

Review 1.  Nanotechnology-Driven Cell-Based Therapies in Regenerative Medicine.

Authors:  D Alzate-Correa; W R Lawrence; A Salazar-Puerta; N Higuita-Castro; D Gallego-Perez
Journal:  AAPS J       Date:  2022-03-15       Impact factor: 3.603

2.  2005 Donor Eligibility Requirements: Unintended Consequences for Stem Cell Development.

Authors:  Larry A Couture; Melissa K Carpenter
Journal:  Stem Cells Transl Med       Date:  2015-08-18       Impact factor: 6.940

Review 3.  Adoptive T cell transfer for cancer immunotherapy in the era of synthetic biology.

Authors:  Michael Kalos; Carl H June
Journal:  Immunity       Date:  2013-07-25       Impact factor: 31.745

4.  Cell-based therapeutics: the next pillar of medicine.

Authors:  Michael A Fischbach; Jeffrey A Bluestone; Wendell A Lim
Journal:  Sci Transl Med       Date:  2013-04-03       Impact factor: 17.956

5.  Lentivirus Manufacturing Process for Primary T-Cell Biofactory Production.

Authors:  Harikrishnan Radhakrishnan; Harold S Javitz; Parijat Bhatnagar
Journal:  Adv Biosyst       Date:  2020-05-10

6.  Pluripotent stem cells in translation: a Food and Drug Administration-National Institutes of Health collaboration.

Authors:  Naomi Kleitman; Mahendra S Rao; David F Owens
Journal:  Stem Cells Transl Med       Date:  2013-06-11       Impact factor: 6.940

Review 7.  Nanoparticles and clinically applicable cell tracking.

Authors:  Monique R Bernsen; Jamal Guenoun; Sandra T van Tiel; Gabriel P Krestin
Journal:  Br J Radiol       Date:  2015-08-07       Impact factor: 3.629

8.  Translating stem cell research to the clinic: a primer on translational considerations for your first stem cell protocol.

Authors:  Timothy O'Brien; Michael Creane; Anthony J Windebank; Andre Terzic; Allan B Dietz
Journal:  Stem Cell Res Ther       Date:  2015-08-22       Impact factor: 6.832

Review 9.  Engineering Therapeutic T Cells: From Synthetic Biology to Clinical Trials.

Authors:  Jonathan H Esensten; Jeffrey A Bluestone; Wendell A Lim
Journal:  Annu Rev Pathol       Date:  2016-12-05       Impact factor: 23.472

10.  Imaging transplanted stem cells in real time using an MRI dual-contrast method.

Authors:  Ethel J Ngen; Lee Wang; Yoshinori Kato; Balaji Krishnamachary; Wenlian Zhu; Nishant Gandhi; Barbara Smith; Michael Armour; John Wong; Kathleen Gabrielson; Dmitri Artemov
Journal:  Sci Rep       Date:  2015-09-02       Impact factor: 4.379
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