![]() ![]() There were also many international policies discussed in 2015, including one proposed by the United Nations Educational, Scientific and Cultural Organization (UNESCO) which called for a moratorium on germline genome editing, but none of these policies became international law. Given the potential of CRISPR to more easily modify the genome, Congress passed a bill in 2015 that prohibits the Food and Drug Administration (FDA) from reviewing any drug or biological product in which a human embryo has been genetically modified ( Figure 3). CRISPR is a much faster and effective way to edit the genome of any cell, but it may cause unintended DNA changes. In 2012, 40 years after the initial development of recombinant DNA technology, scientists uncovered the powers of CRISPR to edit the genome of mammalian cells. ![]() DNA editing made in germline cells (gray) will be passed down to all further generations. DNA editing made in somatic cells (purple) cannot be passed down to future generations. A common fear is that germline genome editing may also lead down a “ slippery slope” towards designer babies. Germline genome editing is controversial because it makes permanent changes to parental egg or sperm cells in humans that can be inherited in all future generations ( Figure 2). ![]() Contrary to somatic gene therapy, in the mid 1990s, national and international guidelines and regulations were established in over 40 countries to prohibit germline genome editing in humans. Today, there are thousands of clinical trials utilizing somatic cell gene therapy with recombinant DNA technology to treat disease. Somatic gene therapy refers to genetic modifications made in non-reproductive cells so the modifications are not passed onto future generations ( Figure 2). In the late 1980s, the RAC first began approving clinical trials using recombinant DNA technology to genetically engineer somatic cells. DNA from one cell (purple) is transferred into the DNA of the second cell (blue) using a virus. The RAC’s principal mandate was to serve as an advisory committee-to review research proposals planning to genetically modify cells and to withhold funding from projects that did not follow the evolving Guidelines. In 1975, the National Institutes of Health (NIH) appointed a Recombinant DNA Advisory Committee (RAC), a group of 25 scientists tasked with creating the NIH Guidelines for Research Involving Recombinant DNA Molecules. This new gene-editing technology allowed for rapid advancements in science, medicine, and agriculture, but it was met with strong pushback on the putative hazards of genetic modification. In 1972, Paul Berg, an American scientist, took genetic material from one cell and inserted it into the genome of another cell with a virus, generating the first recombinant DNA molecule ( Figure 1). Early regulation of gene-editing technology However, a global community of scientists believe it is premature to use CRISPR in human babies because of inadequate scientific review and a lack of international consensus regarding the ethics of when and how this technology should be used. This was a huge step forward for gene therapies, as the potential of CRISPR to treat otherwise incurable diseases seemed possible. Last year, scientists used CRISPR to cure dogs of Duchenne muscular dystrophy. CRISPR, also known as CRISPR/Cas9, can be thought of as “genetic scissors” that can be programmed to edit DNA in any cell. Nearly four months ago, Chinese researcher He Jiankui announced that he had edited the genes of twin babies with CRISPR. ![]()
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