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On 25 November 2018, Antonio Regalado, the senior biomedicine editor at MIT Technology Review, posted a story headlined "Chinese scientists are creating CRISPR babies." He had pieced it together from a clinical-trial registration filed quietly in Beijing. Within hours, an associate professor at the Southern University of Science and Technology in Shenzhen named He Jiankui pre-empted the rest of the news cycle by uploading five YouTube videos confirming that gene-edited twin girls — pseudonymously called Lulu and Nana — had already been born in October 2018. Two days later he flew to the Second International Summit on Human Genome Editing at the University of Hong Kong, where Nobel laureate David Baltimore, chairing the meeting, called He's work "irresponsible." Within a year He was in a Shenzhen prison.
He's plan went back to June 2017. He recruited a Beijing AIDS-advocacy group called Baihualin China League to find seven couples with HIV-positive fathers and HIV-negative mothers — categories that under Chinese fertility rules cannot use ordinary in-vitro fertilisation. The first couple, given the pseudonyms Mark and Grace, attended a recruitment event He held at SUSTech on 10 June 2017. Couples were offered IVF in exchange for permission to edit their embryos. The consent form misdescribed the project as "an AIDS vaccine development project" and stipulated that participants who withdrew before the babies were 28 days old would have to repay all costs plus a 100,000-yuan fine. He forged the ethical-approval certificate from Shenzhen HarMoniCare Women and Children's Hospital, where the administrator Lin Zhitong had ties to a company He had founded called Direct Genomics. The hospital later denied any approval was given.
The technical target was a gene called CCR5, which codes for a co-receptor that HIV uses to enter T-cells. A natural deletion of 32 base pairs in CCR5, called CCR5-Δ32, confers strong resistance to the most common strains of HIV. In 2007 the Berlin patient Timothy Ray Brown became the first person ever cured of HIV after a stem-cell transplant from a donor homozygous for Δ32. He Jiankui aimed to use CRISPR/Cas9 to write a Δ32-like deletion into the embryos of seven IVF couples, then implant the embryos.
He did not produce the Δ32 mutation. Whole-genome sequencing of cord-blood and placenta from the twin girls showed that Lulu carried, on only one of her two chromosome-3 copies, a 15-base-pair in-frame deletion in CCR5 — meaning her cells still produce a functional CCR5 protein. Nana carried a 4-base-pair deletion on one chromosome and an unknown mutation on the other. Neither baby ended up with two clean copies of CCR5-Δ32. Independent reviewers, including Kiran Musunuru of the University of Pennsylvania and Sean Ryder writing in the CRISPR Journal, concluded that the edits were novel mutations of unknown function rather than the protective deletion He had promised the parents. The HIV resistance He had offered was therefore not delivered. Worse, separate research already showed CCR5 deletion enhances synaptic plasticity and stroke recovery in mice; a 2019 Nature Medicine paper from Rasmus Nielsen and Wei Xinzhu of UC Berkeley reported that homozygotes for Δ32 in the UK Biobank cohort died 20 percent more often before age 76 — a paper later retracted in October 2019 for sampling bias, but published widely first.
Robin Lovell-Badge of the Francis Crick Institute, who chaired the Hong Kong session where He presented, has said He kept human embryos out of his draft summary; the news broke before he flew in. He had quietly informed Jennifer Doudna, the CRISPR pioneer at Berkeley, the morning of 25 November; she relayed it to organisers. He arrived at the Hong Kong summit under University security escort. He told the audience he was "proud" of the result and mentioned a second pregnancy already underway. That second pregnancy resulted in a third gene-edited baby, named Amy, born around August 2019.
The collapse was rapid. SUSTech put out a statement on 26 November saying He had been on unpaid leave since February 2018 and that the work happened off campus. On 29 November 2018, Chinese authorities suspended all of He's research, calling his work "extremely abominable in nature." On 21 January 2019 SUSTech fired him. He's manuscript was rejected by both Nature and the Journal of the American Medical Association on ethical grounds. The CRISPR Journal retracted a paper he had submitted on ethical principles for reproductive genome editing. Stanford cleared three of its faculty — William Hurlbut, Matthew Porteus, and Stephen Quake — of any role. Michael Deem, He's American doctoral advisor at Rice University, was the only non-Chinese co-author on the unpublished Nature manuscript; he resigned from Rice in 2020 and started a consulting company called Certus.
On 30 December 2019, the Nanshan District People's Court of Shenzhen found He Jiankui guilty of illegal practice of medicine — China's analogue of practising without a licence — and sentenced him to three years in prison plus a 3-million-yuan fine, about $434,000. Zhang Renli of the Guangdong Academy of Medical Sciences received two years and a 1-million-yuan fine; Qin Jinzhou of SUSTech received eighteen months and 500,000 yuan. All three were banned for life from working in assisted reproduction. The court found He had recruited people to impersonate the parents in physical examinations and had evaded regulators by forgery.
The People's Republic of China amended its Civil Code in 2020 to add Article 1009, prohibiting medical research on human genes that violates ethics or harms the public interest, and added gene-editing offences carrying up to seven years in prison to the 11th Amendment of the Criminal Law. He Jiankui was released from prison in April 2022.