Abstract
Genome editing technology, including zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and clustered regularly interspaced short palindromic repeat (CRISPR)/Cas, has enabled far more efficient genetic engineering even in non-human primates. This biotechnology is more likely to develop into medicine for preventing a genetic disease if corrective genome editing is integrated into assisted reproductive technology, represented by in vitro fertilization. Although rapid advances in genome editing are expected to make germline gene correction feasible in a clinical setting, there are many issues that still need to be addressed before this could occur. We herein examine current status of genome editing in mammalian embryonic stem cells and zygotes and discuss potential issues in the international regulatory landscape regarding human germline gene modification. Moreover, we address some ethical and social issues that would be raised when each country considers whether genome editing-mediated germline gene correction for preventive medicine should be permitted.Electronic supplementary materialThe online version of this article (doi:10.1186/1477-7827-12-108) contains supplementary material, which is available to authorized users.
Highlights
Germline gene modification has been considered to be efficacious against some genetic diseases due to its impact on the entire body of the offspring
Human germline gene modification is largely forbidden by law or guidelines even in countries that are permissive to human embryonic stem cell research [9]
Genome editing technology is more likely to develop into medicine for preventing a genetic disease if corrective genome editing is integrated into assisted reproductive technology (ART), including in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI)
Summary
Germline (oocyte, sperm, zygote, and embryo) gene modification has been considered to be efficacious against some genetic diseases due to its impact on the entire body of the offspring. Potential subjects for genome editing-mediated germline gene correction Genetic engineering can produce site-specific mutations in cells or an organism. Meticulously designing and validating Zinc finger domains in ZFNs, TALE subunits in TALENs, and sgRNAs in CRISPER/Cas which are specific to a target site of a gene is required in order to maximize the efficiency of desired gene modification and minimize the possibility of off-target mutations in genome editing-mediated gene correction. Belgium, Bulgaria, Canada, Denmark, Sweden, and the Czech Republic ban germline gene modification on the grounds that a modified gene may be inherited by offspring or that the gene modification may impair human embryo (Additional file 1: Table S1) It is unclear whether genome editing-mediated germline gene correction is rendered illegal in those countries when. There are many ethical and social issues that should be addressed prior to the initiation of genome editing-mediated germline gene correction for preventive medicine
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