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ABSTRACT
The gene-editing technique CRISPR—clustered regularly interspaced short palindromic repeats—is often depicted as a security threat because it could theoretically allow scientists or amateurs to edit the genome of a variety of organisms and potentially cause harm to humans, plants, and animals. The recent use of CRISPR by Chinese scientist He Jiankui to edit the genome of viable embryos, which resulted in the birth of twin girls, has exacerbated those fears. This article reviews the timeline of the CRISPR-babies experiment, highlights the challenges that contributed to the experiment's failure, and evaluates the risks of CRISPR's use for malevolent purposes. It concludes that although the potential for abuse is great, the technical obstacles are still too significant to allow successful modification that would threaten security.
Notes
1 He Jiankui, “CCR5 Gene Editing in Mouse, Monkey, and Human Embryos Using CRISPR-Cas9,” paper presented at Second International Summit on Human Genome Editing, Hong Kong, November 28, 2018, <https://livestream.com/accounts/7036396/events/8464254/videos/184103056>
2 Ibid.; Jon Cohen, “The Untold Story of the Circle of Trust Behind the World’s First Gene-Edited Babies,” Science Magazine, August 1, 2019, <www.sciencemag.org/news/2019/08/untold-story-circle-trust-behind-world-s-first-gene-edited-babies#sidebar>.
3 He Jiankui, “Q&A Session,” Second International Summit on Human Genome Editing, Hong Kong, November 28, 2018, <https://livestream.com/accounts/7036396/events/8464254/videos/184103056>.
4 Ibid.; XinhuaNet, “Guangdong Releases Preliminary Investigation Result of Gene-Edited Babies,” January 21, 2019, <www.xinhuanet.com/english/2019-01/21/c_137762633.htm; David Cyranoski, “The CRISPR Babies Scandal: What’s Next for Human Genome Editing,” Nature, March 11, 2019, <www.nature.com/articles/d41586-019-00673-1>.
5 David Cyranoski and Sara Reardon, “Chinese Scientists Genetically Modify Human Embryos,” Nature, April 22, 2015, <www.nature.com/news/chinese-scientists-genetically-modify-human-embryos-1.17378.
6 Antonio Regalado, “The Man Who Crossed the Germline,” MIT Technology Review, Vol. 122, No. 1 (2019), pp. 62–69; Cyranoski, “The CRISPR-Baby Scandal.”
7 Sharon Begley, “CRISPR Babies Lab Asked U.S. Scientists for Help to Disable Cholesterol Gene in Human Embryos,” STAT News, December 4, 2018, <www.statnews.com/2018/12/04/crispr-babies-cholesterol-gene-editing/>.
8 Cyranoski, “The CRISPR-Baby Scandal.”
9 Jiankui He, “Evaluating the Safety of Germline Genome Editing in Human, Monkey and Mouse Embryos,” Cold Spring Harbor, July 29, 2017, <www.youtube.com/watch?v=llxNRGMxyCc>.
10 Sharon Begley, “The CRISPR Shocker: How Genome Editing Scientist He Jiankui Rose from Obscurity to Stun the World,” STAT News, December 17, 2018, <www.statnews.com/2018/12/17/crispr-shocker-genome-editing-scientist-he-jiankui/>.
11 He, “Evaluating the Safety of Germline Genome Editing in Human, Monkey and Mouse Embryos.”
12 Ibid.
13 Ibid. Jesse Gelsinger suffered from a rare genetic disease that causes a build-up of ammonia in the blood. The disease has no treatment and is generally lethal. In 1999, Jesse joined a gene-therapy clinical trial at the University of Pennsylvania in Philadelphia which aimed to inject a corrected gene in his cells with the help of an adenovirus (a form of common-cold virus). Jesse died four days after his injection due to a strong immune reaction to the adenovirus. For more details see Meir Rende, “The Death of Jesse Gelsinger, 20 Years Later,” Science History Institute, June 4, 2019, <www.sciencehistory.org/distillations/the-death-of-jesse-gelsinger-20-years-later>.
14 He, “Evaluating the Safety of Germline Genome Editing in Human, Monkey and Mouse Embryos.”
15 For a review of current research on CRISPR and HIV see Qiaoqiao Xiao et al., “Application of CRIPSR Cas9-Based Gene Editing in HIV-1/AIDS Therapy,” Frontiers in Cellular and Infection Microbiology, March 22, 2019, <www.frontiersin.org/articles/10.3389/fcimb.2019.00069/full>.
16 Cohen, “The Untold Story of the Circle of Trust Behind the World’s First Gene-Edited Babies.”
17 Ibid.; Marilynn Marchione, “Chinese Researcher Claims First Gene-Edited Babies,” AP News, November 26, 2018, <www.apnews.com/4997bb7aa36c45449b488e19ac83e86d>.
18 “Diàochá | fēngkuáng de hèjiànkuí yŭ tuìquè de shòu shì zhě” [Investigation: Crazy He Jiankui and the retreated subjects], November 11, 2018, Baidu, <https://baijiahao.baidu.com/s?id=1618471475417466286&wfr=spider&for=pc>.
19 Ibid. See also Jing Bao Nie and Alexander T.M. Cheung, “He Jiankui Genetic Misadventure, Part 3: What Are the Major Ethical Issues?” Hastings Center, January 10, 2019, <www.thehastingscenter.org/jiankuis-genetic-misadventure-part-3-major-ethical-issues/>.
20 Erika Kleiderman, “Re-examining the Ethical and Regulatory Dimensions of Gene Editing in the Wake of the CRISPR Babies Scandal,” Labroots Webinar, October 3, 2019; He, “Q&A Session.”
21 Begley and Joseph, “The CRISPR Shocker”.
22 He, “Q&A Session”; Marchione, “Chinese Researcher Claims First Gene-Edited Babies.”
23 Cohen, “The Untold Story of the Circle of Trust Behind the First Gene-Edited Babies.”
24 Ibid.; Regalado, “The Man Who Crossed the Germline.”
25 Pam Belluck, “Gene-Edited Babies: What a Chinese Scientist Told an American Mentor,” New York Times, April 14, 2019, <www.nytimes.com/2019/04/14/health/gene-editing-babies.html>.
26 He, “Q&A Session.”
27 In January 2019, the Chinese authorities confirmed that the second pregnancy was still underway and that the mother was under medical observation.
28 He, “Q&A Session.”
29 Belluck, “Gene-Edited Babies.”
30 Ibid.
31 Christina Larson, “Gene-Editing Chinese Scientist Kept Much of His Work Secret,” AP News, November 27, 2018, <www.apnews.com/13303d99c4f849829e98350301e334a9>; Cohen, “The Untold Story of the Circle of Trust Behind the World’s First Gene-Edited Babies.”
32 Cohen, “The Untold Story of the Circle of Trust Behind the World’s First Gene-Edited Babies”; Dennis Normile, “Chinese Scientist Who Produced Genetically Altered Babies Sentenced to 3 Years in Jail,” STAT News, December 30, 2019, <www.sciencemag.org/news/2019/12/chinese-scientist-who-produced-genetically-altered-babies-sentenced-3-years-jail>.
33 A copy of Jinakiu He’s consent forms is available at <www.sciencemag.org/sites/default/files/crispr_informed-consent.pdf>.
34 He, “Q&A Session.”
35 Nie and Cheung, “He Jiankui Genetic Misadventure.”
36 Cyranoski, “The CRISPR-Baby Scandal.”
37 Antonio Regalado, “Chinese Scientists Are Creating CRISPR Babies,” MIT Technology Review, November 25, 2018, <www.technologyreview.com/2018/11/25/138962/exclusive-chinese-scientists-are-creating-crispr-babies/>.
38 Shaogang Lu and Yuzhu Chen, “The World’s First Gene Edited Babies Immunized Against AIDS Were Born in China,” people.com.cn, November 26, 2018, <www.thepaper.cn/newsDetail_forward_2671359>(in Chinese); Jing-Bao Nie, “He Jiankui’s Genetic Misadventure: Why Him? Why China?” Hastings Center, December 5, 2018, <www.thehastingscenter.org/jiankuis-genetic-misadventure-china/>; Lu and Chen, “The World’s First Gene Edited Babies Immunized Against AIDS Were Born in China.”
39 Cohen, “The Untold Story of the Circle of Trust Behind the First Gene-Edited Babies.”
40 Antonio Regalado, “Why the Paper on the CRISPR Babies Stayed Secret for so Long,” MIT Technology Review, December 3, 2019, <www.technologyreview.com/s/614761/nature-jama-rejected-he-jiankui-crispr-baby-lulu-nana-paper/>; Marilynn Marchione, “One Year after the ‘CRISPR Babies’ Scandal, the Chinese Scientists Are Still Missing,” Science Alert, November 26, 2019, <www.sciencealert.com/1-year-on-there-s-still-mystery-surrounding-china-s-gene-edited-babies>.
41 Cohen, “The Untold Story of the Circle of Trust Behind the First Gene-edited Babies”; Julia Belluz, “How Soon Will CRISPR Gene-Edited Babies Come to the US?” VOX, December 6, 2018; AP News, “China Says Doctor Behind Gene-Edited Babies Acted on His Own,” January 21, 2019, <www.apnews.com/19c395ef2d3148b1a8ae0ab8be5375b0>; Sisi Xiao and Xiongying Li, “Guangdong Releases Preliminary Investigation Result of Gene-Edited Babies,” XinhuaNet, January 21, 2019, <www.xinhuanet.com/local/2019-01/21/c_1124020517.htm> (in Chinese).
42 Xiao and Li, “Guangdong Releases Preliminary Investigation Result of Gene-Edited Babies”; Cyranoski, “The CRISPR Babies Scandal”; Normile, “Chinese Scientist Who Produced Genetically Altered Babies Sentenced to 3 Years in Jail.”
43 Normile, “Chinese Scientist Who Produced Genetically Altered Babies Sentenced to 3 Years in Jail”; Mark Terry, “Chinese CRISPR Scientist Receives 3 year Prison Sentence and $430,000 Fine,” BioSpace, December 30, 2019, <www.biospace.com/article/china-jails-scientist-who-gene-edited-crispr-twins-/>.
44 He, “Q&A Session.”
45 Marchione, “Chinese Researcher Claims First Gene-Edited Babies.”
46 He, “Q&A Session.”
47 Antonio Regalado, “China CRISPR Babies: Read Exclusive Excerpts from the Unseen Original Research,” MIT Technology Review, December 3, 2019, <www.technologyreview.com/s/614764/chinas-crispr-babies-read-exclusive-excerpts-he-jiankui-paper/>.
48 He, “Q&A Session.” See also American College of Obstetricians and Gynecologists, “Labor and Delivery Management of Women with Human Immunodeficiency Virus Infection,” Committee Opinion, September 2018, <www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2018/09/labor-and-delivery-management-of-women-with-human-immunodeficiency-virus-infection>.
49 Haoyi Wang and Hui Yang, “Gene-Edited Babies: What Went Wrong and What Could Go Wrong,” PLOS Biology, April 30 2019, <https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.3000224>.
50 Robin Lovell-Badge, in He “Q&A Session.”
51 Sharon Begley, “For Rules on Creating ‘CRISPR Babies’ from Edited Embryos, Scientists Call a Do-Over,” STAT News, August 12, 2019, <www.statnews.com/2019/08/12/crispr-babies-rules-scientists-call-for-do-over/>; Marchione, “Chinese Researcher Claims First Gene-Edited Babies.”
52 Begley, “The CRISPR Shocker.”
53 Michael Le Page, “More Details on the Experiment that Shocked the World,” New Scientist, November 28, 2018, <www.newscientist.com/article/2186911-crispr-babies-more-details-on-the-experiment-that-shocked-the-world/>.
54 Jiankui He provided copies of the unpublished article to the Associated Press (AP) in 2018, as part of a story the press agency was preparing about the experiment. AP distributed the manuscript to a few scientists to gain their insights, but never published a dedicated article on the manuscript. More recently, in early 2019, the MIT Technology Review obtained copies of the manuscript from an unidentified source and published some excerpts in an article published in December 2019. The unpublished manuscript was also submitted by He to several scientific journals and reviewed by their editors and/or external reviewers. Nature, which initially deemed the article worthy of consideration, eventually rejected it due to the ethical and legal concerns it raised. BioRxiv rejected the article for similar reasons. He later submitted the manuscript to the Journal of the American Medical Association, which had it reviewed by 11 reviewers, but decided to reject it in January 2019. See Regalado, “China CRISPR Babies.”
55 Kiran Musunuru, “Opinion: We Need to Know What Happened to CRISPR Twins Lulu and Nana,” MIT Technology Review, December 3, 2019, <www.technologyreview.com/s/614762/crispr-baby-twins-lulu-and-nana-what-happened/>.
56 Cohen, “The Untold Story of the Circle of Trust Behind the World’s First Gene-Edited Babies”; see also Jiankui He, “CV,” Linkedin, <www.linkedin.com/in/jiankui-he-a1917517/?originalSubdomain=cn>.
57 He, “CV.”
58 Mark Terry, “CRISPR Scandal Drags in Another US Researcher, Stanford’s Quake,” Biospace, April 15, 2019, <www.biospace.com/article/stanford-s-quake-questioned-regarding-involvement-in-chinese-crispr-babies/>.
59 Jiankui He and Michael Deem, “Heterogenous Diversity of Spacers within CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats),” Physical Review Letters, September 17, 2010, <https://journals.aps.org/prl/pdf/10.1103/PhysRevLett.105.128102>.
60 He, “CV”; see also SUStech, “Jiankui He: Publications in Refereed Journals,” <https://web.archive.org/web/20181126211939/<www.sustc-genome.org.cn/publication.html>.
61 Luyang Zhao et al., “Single Molecule Sequencing of the M13 Virus Genome without Amplification,” PLoS One, December 18, 2017, <www.ncbi.nlm.nih.gov/pubmed/29253901>; Minyue Dong et al., “Single Molecule Sequencing of Cell-Free DNA from Maternal Plasma from Noninvasive Trisomy Detection,” bioRxiv, October 27, 2017, <www.biorxiv.org/content/10.1101/209924v1.full>.
62 Jiankui He and Michael W. Deem, “Hierarchical Evolution of Animal Body Plans,” Developmental Biology, Vol. 337, No. 1 (2010), pp. 157–61.
63 Jiankui He and Michael W. Deem, “Low-Dimensional Clustering Detects Incipient Dominant Influenza Strain Clusters,” Protein Engineering, Design and Selection, Vol. 23, No. 12, (2010), pp. 935–46.
64 Jiankui He and Michael W Deem, “Structure and Response in the World Trade Network,” Physical Review Letters, November 15, 2010, <https://journals.aps.org/prl/pdf/10.1103/PhysRevLett.105.198701>.
65 Lisa M. Krieger, “Scientist at Center of Gene-Editing Controversy Worked at Stanford,” Mercury News, December 4, 2018, <www.mercurynews.com/2018/11/27/controversial-crispr-scientist-studied-at-stanford/>; He, “CV.”
66 Ning Jiang et al., “Lineage Structure of the Human Antibody Repertoire in Response to Influenza Vaccination,” Science Translational Medicine, Vol. 5, No. 171 (2013), <https://stm.sciencemag.org/content/5/171/171ra19>.
67 Quake is one of the founders and board members of Agenovir, a biotech company that aims to combine Quake’s research on viral infections and CRISPR-Cas9 to treat diseases caused by latent or persistent viral infections. David Holley, “Agenovir Gets $10.6M to Take on Viral Infections with CRISPR,” Xconomy, May 18, 2016, <https://xconomy.com/san-francisco/2016/05/18/agenovir-gets-10-6m-to-take-on-viral-infections-with-crispr/>; he also contributed to a research paper that describes the discovery of a new Cas9 enzyme resistant to higher temperatures. It is worth noting that Quake’s contribution was in the analysis of the data, and writing the paper, not in doing the actual research. See Stephanie T. Schmidt et al., “Nucleaic Acid Cleavage with a Hyperthermophilic Cas9 from an Uncultured Ignavibacterium,” Proceedings of the National Academy of Sciences of the United States of America, Vol. 116, No. 46 (2019), pp. 23100–05, <www.pnas.org/content/116/46/23100.short?rss=1>.
68 Pam Belluck, “Gene-Edited Babies: What a Chinese Scientist Told an American Mentor,” New York Times, April 14, 2019, <www.nytimes.com/2019/04/14/health/gene-editing-babies.html>.
69 Broad Institute, “CRISPR Timeline,” <www.broadinstitute.org/what-broad/areas-focus/project-spotlight/crispr-timeline>.
70 Laura He, Jane Zhang, and Louise Moon, “Who Are the Investors Supporting He Jiankui, the Chinese Scientist Behind the Gene-Edited Babies?” South China Morning Post, November 29, 2018, <www.scmp.com/business/china-business/article/2175486/who-are-investors-supporting-he-jiankui-chinese-scientist>; see also Ma Jing Chen Weicheng, “Businessman He Jiankui Gene Business,” Sina.Com, November 17, 2018, <https://finance.sina.com.cn/china/gncj/2018-11-27/doc-ihpevhck8461145.shtml>.
71 The Peacock program was created in 2011 by the city of Shenzen to attract up-and-coming scientists, offering them state-of the-art-labs and generous research funding and salaries.
72 Cohen, “The Untold Story of the Circle of Trust Behind the First Gene-Edited Babies,” Science, August 1, 2019; see also China Innovation Funding, “Thousand Talent Plan,” <chinainnovationfunding.eu/thousand-talents-plan/>.
73 Aaron Krol, “Direct Genomics’ New Clinical Sequencer Revives a Forgotten DNA Technology,” Bio.ITWorld, October 29, 2015, <www.bio-itworld.com/2015/10/29/direct-genomics-new-clinical-sequencer-revives-forgotten-dna-technology.html>; Begley, “The CRISPR Shocker”; Zach Coleman, “Chinese ‘Baby Editing’ Scientist Retreats from Flagship Company,” Nikkei Asian Review, July 16, 2019, <https://asia.nikkei.com/Business/Biotechnology/Chinese-baby-editing-scientist-retreats-from-flagship-company>.
74 Coleman, “Chinese ‘Baby Editing’ Scientist Retreats from Flagship Company.”
75 Ryan Ferrell, “China’s Direct Genomics Introduces the First Single Molecule Genome Sequencer for the Clinic,” CISION PRWeb, October 27, 2015, <www.prweb.com/releases/2015/10/prweb13044436.htm>; David Cyranoski, “Direct Genomics Revives Helicos Sequencing System for China’s Hospitals,” Nature Biotechnology, February 5, 2016, <www.nature.com/articles/nbt0216-122b>; Jane Qiu, “Chinese Government Funding May Have Been Used for ‘CRISPR Babies’ Project, Documents Suggest,” STAT News, February 25, 2019, <www.statnews.com/2019/02/25/crispr-babies-study-china-government-funding/>.
76 The larger biotech company, Beijing Genomic Institutes, launched its own BGISEQ-500 in 2015. See also Krol, “Direct Genomics’ New Clinical Sequencer Revives a Forgotten DNA Technology”; Direct Genomics, “Crunchbase,” <www.crunchbase.com/organization/direct-genomics#section-overview>; Cyranoski, “Direct Genomics Revives Helicos Sequencing System for China’s Hospitals.”
77 Jane Qiu, “Chinese Government Funding May Have Been Used for ‘CRISPR Babies’ Project, Documents Suggest,” STAT News, February 25, 2019, <www.statnews.com/2019/02/25/crispr-babies-study-china-government-funding/>.
78 Laura He, Jane Zhang, and Louise Moon, “Man Behind ‘Gene-Edited Babies’ Has $40 Million in Start-Up Funding,” Inkstone, November 29, 2018, <www.inkstonenews.com/business/investors-behind-he-jiankui-chinese-scientist-who-claims-have-created-genetically-edited-babies/article/2175607>.
79 Brian Wang, “Scientist Who Edited Humans Was Very Active in Biotech Startups,” NextBig future, January 10, 2019, <www.nextbigfuture.com/2019/01/scientist-who-edited-humans-was-very-active-in-many-biotech-startups.html>.
80 Jing-Bao Nie, “He Jiankui’s Genetic Misadventure: Why Him? Why China?” Hastings Center, December 5, 2018, <www.thehastingscenter.org/jiankuis-genetic-misadventure-china/>.
81 CRISPR scientist, email correspondence with author, March 24, 2020.
82 The other members of the scientific team, aside from Jiankui He and Michael Deem who had no expertise in the field, were students whose expertise could not be verified.
83 Regalado, “Chinese Scientists Are Creating CRISPR Babies”; Antonio Regalado, “He Jiankui Faces Three Years in Prison for CRISPR Babies,” MIT Technology Review, December 30, 2019, <www.technologyreview.com/s/614997/he-jiankui-sentenced-to-three-years-in-prison-for-crispr-babies/>.
84 Marchione, “Chinese Researcher Claims First Gene-Edited Babies.”
85 Xiaoqing Zhou profile, Wuyi University, <www.wyu.edu.cn/swjk/info/1072/2215.htm>.
86 Regalado, “He Jiankui Faces Three Years in Prison for CRISPR Babies.”
87 Ibid.
88 A list of Zhang’s publication can be found on PubMed. Only articles authored by Zhang Renli from the Reproductive Medicine Center in Guangzhou were taken into account: <www.ncbi.nlm.nih.gov/pubmed/?term=Zhang%20RL%5BAuthor%5D&cauthor=true&cauthor_uid=19527377>.
89 The He Lab, “Gene Surgery in Embryos: An Embryologist Explains How It Works,” November 25, 2018, Youtube, <www.youtube.com/watch?v=-1mivZUXgNI>.
90 Haiyang, “He Jiankui Genetic Editing Infant, Program Assistant Qin Jinzhou Hospital: Uninformed, Not Involved,” The Paper, November 17, 2018, <www.thepaper.cn/newsDetail_forward_2677070> (in Chinese).
91 Haiyang, “He Jiankui Genetic Editing Infant, Program Assistant Qin Jinzhou Hospital.”
92 Jeanne O'Brien, MD, Chair, Ethics Committee, Shady Grove Fertility, Rockville, MD, email correspondence with author, January 25, 2021.
93 The He Lab, “Gene Surgery in Embryos.”
94 Yongyang Cheng, “Brave New World with Chinese Characteristics,” Bulletin of the Atomic Scientists, January 13, 2019, <https://thebulletin.org/2019/01/brave-new-world-with-chinese-characteristics/>.
95 Qin’s list of publications can be found at <www.semanticscholar.org/author/Jinzhou-Qin/6906049>.
96 PubMed lists three publications under Qin’s name and affiliation, two published in 2017 (one of which also lists He and Zhang as co-authors), and one in 2019. The 2019 paper is a statistical analysis of IVF success rates in the United States and China, which did not involve laboratory work. One of the 2017 articles analyzes the effects of the culture media on the success rate of IVF. In this paper, Qin is listed as the second author. However the experiment took place in Arizona, with embryos from patients of the Center for Reproductive Endocrinology and Fertility, so it seems unlikely that Qin directly contributed to the laboratory work. See Linda Wu, Jinzhou Qin, Dikai Zhang, Minqi Zhang, Suzhen Lu, Jennifer Howell, Timothy J. Gelety, and Bin Wu, “Effect of Assisted Reproductive Technology (ART) on Babies Born: Compared by IVF Laboratories of Two Countries,” Embryology: Theory and Practice, July 9, 2019, <www.intechopen.com/books/embryology-theory-and-practice/effect-of-assisted-reproductive-technology-art-on-babies-born-compared-by-ivf-laboratories-of-two-co>; Bin Wu, Jinzhou Qin, Suzhen Lu, Linda Wu, and Timothy J. Gelety, “Improving ART Pregnancy Rate with Two Kinds of Media and Two Types of Incubators,” Embryo Cleavage, September 6, 2017, <www.intechopen.com/books/embryo-cleavage/improving-art-pregnancy-rate-with-two-kinds-of-media-and-two-types-of-incubators>.
97 Minyue Dong, Liwei Deng, Huan Jin, Jinsen Cai, Huan Shang, Shuo Zhang, Yueping Zhang, Jinzhou Qin, Dikai Zhang, Feng Long, Renli Zhang, Runsheng Chen, Michael W. Deem, Jun Yu, and Jiankui He, “Single Molecule Sequencing of Cell-Free DNA from Maternal Plasma from Noninvasive Trisomy Detection,” bioRxiv, October 27, 2017, <www.biorxiv.org/content/10.1101/209924v1.full>.
98 Xiaoqing Zhou, School of Biotechnology and Health, Wuyi University, China, <www.wyu.edu.cn/swjk/info/1072/2215.htm.
99 Ibid.
100 Xiaoqing Zhou et al., “Generation of CRISPR/Cas9-Mediated Gene-Targeted Pigs via Somatic Cell Nuclear Transfer,” Cellular and Molecular Life Sciences, Vol. 72, No. 6 (2015), pp. 1175–84; Shu Wei et al., “Conversion of Embryonic Stem Cells into Extraembryonic Lineages by CRISPR-Mediated Activators,” Scientific Reports, Vol. 6, Article No. 19648 (2016), <https://www.nature.com/articles/srep19648#citeas>; Sisi Lai et al., “Generation of Knock-in Pigs Carrying Oct4-tdTomato Reporter through CRISPR/Cas9- Q14 Mediated Genome Engineering,” PLoS One, Vol. 11, No. 1 (2016), <https://doi.org/10.1371/journal.pone.0146562>.
101 Sharon Begley, “’CRISPR Babies’ Lab Asked U.S. Scientist for Help to Disable Cholesterol Gene in Human Embryos,” STATNews, December 4, 2018, <www.statnews.com/2018/12/04/crispr-babies-cholesterol-gene-editing/>.
102 Regalado, “The Man Who Crossed the Germline.”
103 Ibid.; Antonio Regalado, “Years Before CRISPR Babies, This Man Was the First to Edit Human Embryos,” MIT Technology Review, December 11, 2018, <www.technologyreview.com/s/612554/years-before-crispr-babies-this-man-was-the-first-to-edit-human-embryos/>; Christie Rizk, “CRISPR License Agreements Prohibits Misuse, but Enforcement Is Challenging,” Genomeweb, May 7, 2019, <www.genomeweb.com/gene-silencinggene-editing/crispr-license-agreements-prohibit-misuse-enforcement-challenging#.XoN66C2ZNN0>.
104 Candice Choi and Marilynn Marchione, “US Nobelist Was Told of Gene-Edited Babies,” AP News, January 28, 2019, <https://apnews.com/3f3bdc73e7c84fe685f2813510329d62>.
105 Ibid. For Luzariaga’s profile, see <www.umassmed.edu/ccts/about/pi-and-director/>.
106 Munsunuru conducted a study in 2014 on using CRISPR to edit mice liver cells. See Qiurong Ding et al., “Permanent Alteration of PCSK9 with in Vivo CRISPR-Cas9 Genome Editing,” Circulation Research, Vol 115, No. 5 (2014), <www.ncbi.nlm.nih.gov/pubmed/24916110>.
107 Begley, “‘CRISPR Babies’ Lab Asked U.S. Scientist for Help to Disable Cholesterol Gene in Human Embryos.”
108 Ibid.
109 National Academies of Sciences, Engineering and Medicine, “Human Genome Editing: Science, Ethics and Governance,” Consensus Study Report, 2017, <www.nap.edu/catalog/24623/human-genome-editing-science-ethics-and-governance>.
110 Cohen, “The Untold Story of the Circle of Trust Behind the First Gene-Edited Babies”; Begley, “The CRISPR Shocker.”
111 Cohen, “The Untold Story of the Circle of Trust Behind the First Gene-Edited Babies.”
112 Andrew Joseph, “An Outsider Claimed to Make Genome Editing History—and the World Snapped to Attention,” STATNews, November 26, 2018, <www.statnews.com/2018/11/26/he-jiankui-gene-edited-babies-china/>.
113 Begley, “CRISPR Babies Lab Asked U.S. Scientists for Help to Disable Cholesterol Gene in Human Embryos.”
114 Qiaoqiao Xiao, Deyin Guo, and Shuliang Chen, “Application of CRISPR/Cas9-Based Gene Editing in HIV-1/AIDS Therapy,” Frontiers in Cellular and Infection Microbiology, March 22, 2019, <www.frontiersin.org/articles/10.3389/fcimb.2019.00069/full>; Henry T. Greely, “He Jiankui, Embryo Editing, CCR5, the London Patient, and Jumping to Conclusions,” STAT News, April 15, 2019, <https://www.statnews.com/2019/04/15/jiankui-embryo-editing-ccr5/>; He, “Q&A Session.”
115 For an overview of using CRISPR to attack HIV see Wang and Yang, “Gene-Edited Babies.”
116 Zhen Wang, Qingua Pan, Patrick Gendron, Weijun Zhu, Fei Guo, Shan Cen, Mark A.Wainberg, and Chen Liang, “CRISPR/Cas9-Derived Mutations Both Inhibit HIV-1 Replication and Accelerate Viral Escape,” Cell, April 7, 2016, pp. 485–89, <www.sciencedirect.com/science/article/pii/S2211124716302984>; Ewen Callaway, “HIV Overcomes Gene-Editing Attack,” Nature, April 7, 2016, <www.nature.com/news/hiv-overcomes-crispr-gene-editing-attack-1.19712>; Wang and Yang, “Gene-Edited Babies.” Recent research has also shown that other viruses are able to escape the CRISPR system. See Senen D. Mendoza, Eliza S. Nieweglowska, Sutharsan Govindarajan, Lina M. Leon, Joel D. Berry, Anika Tiwari, Vorrapon Chaikeeratisak, Joe Pogliano, David A. Agard, and Joseph Bondy-Denomy, “A Bacteriophage Nucleus-Like Compartment Shields DNA from CRISPR Nucleases,” Nature, December 9, 2019, <www.nature.com/articles/s41586-019-1786-y>.
117 Wang and Yang, “Gene-Edited Babies.”
118 Ibid.
119 Ibid.
120 Ibid.
121 Regalado, “China CRISPR Babies.”
122 Ibid. For more details on the challenges of checking for off-target effects in human embryos see also Rebecca Lea and Kathy Niakan, “Human Germline Genome Editing,” Nature Cell Biology, Vol. 21 (December 2019), pp. 1479–89.
123 Regalado, “China CRISPR Babies.”
124 Ibid.
125 Cohen, “The Untold Story of the Circle of Trust Behind the World’s First Gene-Edited Babies.”
126 Kathleen Vogel and Sonia Ben Ouagrham-Gormley, “Anticipating Emerging Biotechnology Threats: A Case Study of CRISPR,” Politics and the Life Sciences, Vol 37, No. 2 (2018), pp. 203–19.
127 See, for example, Pinar Ackakaya et al., “In Vivo CRISPR-Cas Gene Editing with No Detectable Genome-Wide Off-Target Mutations,” BioRxiv, February 27, 2018, <www.nature.com/articles/s41586-018-0500-9>; Henriette O’Geen, Abigail S. Yu, and David J. Sega, “How Specific Is CRISPR/Cas9 Really?” Current Opinion in Chemical Biology, Vol. 29 (2015), pp. 72–78; Chuai Guo-hui, Wang Qi-Long, and Liu Qi, “In Silico Meets in Vivo: Towards Computational CRISPR-Based sgRNA Design,” Trends in Biotechnology, Vol. 35, No. 1 (2017), pp. 12–21; Jennifer E. Chapman, David Gillum, and Samira Kiani, “Approaches to Reduce CRISPR Off-Target Effects for Safer Genome Editing,” Applied Biosafety, Vol. 22, No. 1 (2017), pp. 7–13.
128 Lea and Niakan, “Human Germline Genome Editing.”
129 See, for example, Edward A. Stadtmauer et al., “CRISPR-Engineered T Cells in Patients with Refractory Cancer,” Science, Vol. 367, No. 6481 (2020), <https://science.sciencemag.org/content/367/6481/eaba7365>; Dennis Normile, “China Sprints Ahead in CRISPR Therapy Race,” Science Magazine, Vol. 358, No. 6359 (2017), pp. 20–21, <https://science.sciencemag.org/content/358/6359/20>.
130 Marilynn Marchione, “Doctors Try First CRISPR Editing in the Body for Blindness,” AP News, March 4, 2020, <https://apnews.com/17fcd6ae57d39d06b72ca40fe7cee461>.
131 Ibid.; Tina Hesman Saey, “CRISPR Enters Its First Human Clinical Trials,” ScienceNews, August 14, 2019, <www.sciencenews.org/article/crispr-gene-editor-first-human-clinical-trials>.
132 Kathleen Vogel and Sonia Ben Ouagrham-Gormley, “Anticipating Emerging Biotechnology Threats: A Case Study of CRISPR,” Politics and the Life Sciences, Vol. 37, No. 2 (2018), pp. 203–19. See also Ling Li, Zhi-Yao He, Xia-Wei Wei, Guang-Ping Gao, and Yu-Quan Wei, “Challenges in CRISPR/CAS9 Delivery: Potential Roles of Nonviral Vectors,” Human Gene Therapy, Vol. 26, No. 7 (2015), pp. 452–62, <www.tandfonline.com/doi/full/10.1080/10717544.2018.1474964>; Christopher A. Lino, Jason C. Harper, James P. Carney, and Jerilyn A. Timlin, “Delivering CRISPR: A Review of the Challenges and Approaches,” Drug Delivery, Vol. 25, No. 1 (2018), pp. 1234–57, <www.ncbi.nlm.nih.gov/pmc/articles/PMC6058482/>.
133 John Cohen, “Moratorium for Germline Editing Splits Biologists,” Science, March 15, 2019, <https://science.sciencemag.org/content/363/6432/1130>.
134 WHO, “WHO Launches Registry on Human Genome Editing,” press release, August 29, 2019, <www.who.int/news-room/detail/29-08-2019-who-launches-global-registry-on-human-genome-editing>.
135 Nature, “China Set to Introduce Gene-Editing Regulations Following CRISPR-Baby Furore,” May 20, 2019, <www.nature.com/articles/d41586-019-01580-1>; Bloomberg News, “China Proposes Stricter Rules on Gene Editing after Scandal,” February 27, 2019, <www.bloomberg.com/news/articles/2019-02-27/china-proposes-stricter-rules-after-rogue-gene-scientist-scandal>.
136 R. Alta Charro, “Rogues and Regulation of Germline Editing,” New England Journal of Medicine, Vol. 380, No. 10 (2019), pp. 976–80, <www.nejm.org/doi/full/10.1056/NEJMms1817528>.
137 Megan Molteni, “US Biotech Firms Made China’s Gene-Edited Babies Possible,” Wired, November 30, 2018, <www.wired.com/story/us-biotech-firms-made-chinese-crispr-babies-possible/>.
138 See, for example, Cohen, “The Untold Story of the Circle of Trust Behind the World’s First Gene-Edited Babies;” Begley, “The CRISPR Shocker.”
139 Rory O’Neil, “EPO Revokes Broad’s CRISPR Patent,” Life Sciences Intellectual Property Review, January 16, 2020, <www.lifesciencesipreview.com/news/breaking-epo-performs-backflip-in-broad-s-crispr-hearing-3869>; Amy Sandys, “EPO Revokes Broad Institute Patent—but It Is Just the Beginning for CRISPR-Cas,” Juve Patent, January 17, 2020, <www.juve-patent.com/news-and-stories/cases/epo-revokes-broad-institute-patent-but-its-just-the-beginning-for-crispr-cas/>.