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International outcry over world’s first gene-edited babies born in China
Babies claimed to be immune from contracting HIV

A research team led by Dr. Jiankui He made an announcement on 25 November that a pair of gene-edited babies were born in China in November. The announcement was made in English via a Youtube video by Dr. He.

This announcement was quickly met with criticisms from scientific communities within China and abroad, prompting the Chinese state and provincial government to launch an investigation into Dr. He’s claims.

Dr. Jiankui He announced that he had edited the CCR5 gene (C-C chemokine receptor type 5 gene) in early-stage embryos, which were obtained through in vitro fertilisation (IVF) from volunteer couples.

Two gene-edited embryos were implanted into the womb of the biological mother, resulting in twin baby girls with psudonyms Lulu and Nana. The gene-editing tool used is the popular CRISPR-Cas9 system first discovered in 2012. The edited CCR5 genes supposedly confer immunity to HIV-1 infection, as the virus requires the assistance of the CCR5 gene product to enter cells.

On 28 November, Dr. He attended the Second International Summit on Human Genome Editing held in Hong Kong and gave a pre-scheduled presentation, followed by a Q&A session. He further revealed that initially eight volunteer couples were recruited via an AIDS advocacy group, but one couple dropped out before the IVF procedure. To participate in the trial, the male must be HIV-positive while the female is HIV-negative. Pre-implantation genetic diagnosis was used to check if the targeted genes were edited as planned. He said he was proud of this project and would continue to monitor the health conditions of the twin girls.

The claimed results have not yet been scientifically peer reviewed or published in a scientific journal.

Dr. Jiankui He is currently affiliated with the Southern University of Science and Technology in Shenzhen, Guangdong, China. However, the university said that Dr. He had been granted no-pay leave for three years since February 2018 to pursue his business interests and the university was not aware of this gene editing clinical trial. The university also said that the ethics committee of the university had found Dr. He’s conduct in breach of ethical standards of the university and would investigate this matter. Dr He is the founder and chairman of a company called Direct Genomics (瀚海基因), which was founded in 2012 and focuses on single-molecule DNA sequencing systems for clinical use. Dr. He also declared on 28 November that the university was unaware of the trial, and the project was mostly funded by his own resources. He said his company is also not involved in this project.

After the news is reported in the media, hundreds of scientists from China signed online petitions to condemn Jiankui He’s human experiment. The Genetics Society of China (Subcommittee on Gene Editing) and Chinese Society for Cell Biology (Subcommittee on Stem Cell Biology) also issued statements to express their disapproval of the human trial.

Prof. Anming Meng, Academician of the Chinese Academy of Sciences and Professor of the College of Life Sciences, Tsinghua University, said, “This experiment has huge technical risk and ethical concerns.”

At present, CRISPR-Cas9 gene editing tool is still associated with off-target effect, where the gene editing does not occur at the correct site but at a distance away from the targeted genes. This technical hurdle can potentially make the gene editing tool unsafe for use.

Also, as pointed out by Academician Meng, CCR5 has important roles to play in human immune system, as it acts as a receptor for chemokines. There could be potential hazards knocking out functional CCR5 genes in humans, and this has not yet been well studied.

Prevention of AIDS was the main purpose of the human gene editing trial, but this was heavily criticised. As Prof. Chen Zhiwei, Director of the AIDS Institute at the University of Hong Kong, explained: HIV virus can mutate, and even if the CCR5 gene is knocked out, there is no guarantee that this will stop HIV infection. “HIV-positive father and healthy mother could have healthy babies without any need for CCR5 gene editing.” Prof. Chen said. There are effective drugs to keep infection at a controllable level. Healthy sperms could also be selected during the sperm washing step prior to in vitro fertilization, and the babies will be born healthy.

Also, even if there is not any technical problem, there is also the ethical question of whether germline gene editing should be allowed to produce a human being, as the edited genes will be passed down from generation to generation and contribute to the human gene pool.

“Who would be responsible for the two babies?” queried Prof. Anming Meng.

The ethics approval process is also plagued with problems. Documents downloaded from the Chinese clinical trials registry show that the project was approved in March 2017 by the ethics committee of Shenzhen HarMoniCare Women & Children's Hospital, a private hospital in Shenzhen city. However, the hospital denied having discussed this project, and said the babies were not born in the hospital. There has been public outcry over whether such an important human gene editing trial could be approved by an institutional ethics committee.

A member of the National Health Commission's Bioethics Expert Committee said: "This is a major ethical issue. The hospital ethics committee is not qualified to review clinical trials involving editing of human genes. This should be escalated to the higher level of government authority for approval, or even the state level authority.” Hospital ethics committees are qualified to review the approval of simple drug trials and other surgeries.

Zhai Xiaomei, a professor and executive director of the Center for Bioethics of the Chinese Academy of Medical Sciences and Peking Union Medical College, said the country's regulatory framework in the field mainly consists of guidelines issued by government departments. Relevant laws, with clear-cut penalties, remain absent. Stipulations in guidelines do not carry the power to impose legal penalties when people break ethical rules, Zhai said.

Following the incident, the National Health Commission said Prof He's work seriously violates China's regulations and ethical standards and would launch an investigation into his claims. The Deputy Minister of Science and Technology, Academician Nanping Xu clarified that in vitro human embryonic stem cell research is only allowed for a maximum period of 14 days, after which the embryos need to be destroyed and cannot be implanted into the uterus.

As Jennifer Doudna, the pioneer of the CRISPR system, said during a presentation at the Royal Swedish Academy of Sciences, “CRISPR research is notable not just for the exciting applications, but also for its profound ethical implications.”

Recommended Reading:

Jennifer Doudna. CRISPR System: From Adaptive Immunity to Genome Editing. Molecular Frontiers Journal, 1(2): 76-91 (2017). World Scientific Publishing, Singapore.

"To edit or not?"- the dilemma around CRISPR. Asia Pacific Biotech News, vol. 19, Issue 7, July 2015.

Source: Sciencenet.cn, China Daily, BBC Chinese, Wikipedia

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