Literature DB >> 30017092

The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage?

Toni Cathomen1, Silke Schüle2, Martina Schüßler-Lenz2, Mohamed Abou-El-Enein3.   

Abstract

Medicinal products based on genome editing must undergo rigorous preclinical testing and are subject to regulatory oversight for proper risk assessment prior to first evaluation in humans. We give a European perspective on the regulatory expectations to translate genome editing to the clinic to ensure their timely progress to market.
Copyright © 2018 Elsevier Ltd. All rights reserved.

Entities:  

Keywords:  CRISPR; clinical trials; commercialization; ethics; genome editing; regulation

Mesh:

Year:  2018        PMID: 30017092     DOI: 10.1016/j.tibtech.2018.06.005

Source DB:  PubMed          Journal:  Trends Biotechnol        ISSN: 0167-7799            Impact factor:   19.536


  6 in total

1.  In Vivo HSC Gene Therapy Using a Bi-modular HDAd5/35++ Vector Cures Sickle Cell Disease in a Mouse Model.

Authors:  Chang Li; Hongjie Wang; Aphrodite Georgakopoulou; Sucheol Gil; Evangelia Yannaki; André Lieber
Journal:  Mol Ther       Date:  2020-09-05       Impact factor: 11.454

Review 2.  From fiction to science: clinical potentials and regulatory considerations of gene editing.

Authors:  Maria Schacker; Diane Seimetz
Journal:  Clin Transl Med       Date:  2019-10-21

3.  Mesenchymal Stem/Stromal Cells Overexpressing CXCR4R334X Revealed Enhanced Migration: A Lesson Learned from the Pathogenesis of WHIM Syndrome.

Authors:  Hamid Reza Bidkhori; Ahmad Reza Bahrami; Moein Farshchian; Asieh Heirani-Tabasi; Mahdi Mirahmadi; Halimeh Hasanzadeh; Naghmeh Ahmadiankia; Reza Faridhosseini; Mahtab Dastpak; Arezoo Gowhari Shabgah; Maryam M Matin
Journal:  Cell Transplant       Date:  2021 Jan-Dec       Impact factor: 4.064

Review 4.  Applications of CRISPR-Cas9 as an Advanced Genome Editing System in Life Sciences.

Authors:  Kamand Tavakoli; Alireza Pour-Aboughadareh; Farzad Kianersi; Peter Poczai; Alireza Etminan; Lia Shooshtari
Journal:  BioTech (Basel)       Date:  2021-07-06

Review 5.  Unproven stem cell interventions: A global public health problem requiring global deliberation.

Authors:  Zubin Master; Kirstin R W Matthews; Mohamed Abou-El-Enein
Journal:  Stem Cell Reports       Date:  2021-06-08       Impact factor: 7.765

6.  CRISPR-Cas9-Edited Tacrolimus-Resistant Antiviral T Cells for Advanced Adoptive Immunotherapy in Transplant Recipients.

Authors:  Leila Amini; Dimitrios Laurin Wagner; Uta Rössler; Ghazaleh Zarrinrad; Livia Felicitas Wagner; Tino Vollmer; Désirée Jacqueline Wendering; Uwe Kornak; Hans-Dieter Volk; Petra Reinke; Michael Schmueck-Henneresse
Journal:  Mol Ther       Date:  2020-09-08       Impact factor: 11.454

  6 in total

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