sharon sanders
Editor-in-Chief & President
Following the death of a 6-year-old girl in a gene-editing experiment, another child has died. The founder of Shanghai Huida Gene, involved in the experiment, has been accused of plagiarism.
August 7, 2026, 20:53,
On August 5, 2026, STAT News, a well-known American biomedical media outlet, exposed a major safety incident in the field of gene editing in China . In the first human clinical trial of HG302 Duchenne Muscular Dystrophy CRISPR independently developed by Shanghai Huida Gene a male participant suddenly developed a severe immune response after being given a high dose of the drug and unfortunately passed away
According to Intellectuals, the collaborator in the trial was Shanghai Children's Medical Center, affiliated with Shanghai Jiao Tong University School of Medicine .
A year has passed since the incident was exposed .
This is the second publicly reported death of a gene therapy participant in an Investigator-Initiated Clinical Trial (IIT) conducted by Chinese researchers in the past month, and it has once again sparked discussions in the international academic community about IIT regulation, information disclosure, and participant safety.
The HG302 project involved in this incident is a first-in-human , open-label, dose-escalation early-stage clinical study. It is an investigator-initiated clinical trial that only requires approval from the hospital's ethics committee —the Clinical Trial Registration Record (ID: NCT06594094)
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Subsequently, the company did not publicly disclose any research progress for 15 months. In February of this year, the clinical trial registration information was updated to "completed."
snip
The child received a systemic intravenous injection of AAV vector in August 2025, which led to severe activation of the complement system and cytokines, rapidly progressing to acute respiratory distress syndrome (ARDS), and ultimately resulting in death despite resuscitation efforts
more.....zhttps://k.sina.com.cn/article_5953189932_162d6782c06704ugc8.html?cre=tia nyi&mod=pcpager_news&loc=19&r=0&rfunc=28&tj=cxvert ical_pc_pager_news&tr=174
Link to original STAT report:
Once again, child dies in gene-editing trial in China, rekindling debate on transparency and safety
https://www.statnews.com/2026/08/05...ty-safety-questions-investigator-led-studies/
August 7, 2026, 20:53,
On August 5, 2026, STAT News, a well-known American biomedical media outlet, exposed a major safety incident in the field of gene editing in China . In the first human clinical trial of HG302 Duchenne Muscular Dystrophy CRISPR independently developed by Shanghai Huida Gene a male participant suddenly developed a severe immune response after being given a high dose of the drug and unfortunately passed away
According to Intellectuals, the collaborator in the trial was Shanghai Children's Medical Center, affiliated with Shanghai Jiao Tong University School of Medicine .
A year has passed since the incident was exposed .
This is the second publicly reported death of a gene therapy participant in an Investigator-Initiated Clinical Trial (IIT) conducted by Chinese researchers in the past month, and it has once again sparked discussions in the international academic community about IIT regulation, information disclosure, and participant safety.
The HG302 project involved in this incident is a first-in-human , open-label, dose-escalation early-stage clinical study. It is an investigator-initiated clinical trial that only requires approval from the hospital's ethics committee —the Clinical Trial Registration Record (ID: NCT06594094)
snip
Subsequently, the company did not publicly disclose any research progress for 15 months. In February of this year, the clinical trial registration information was updated to "completed."
snip
The child received a systemic intravenous injection of AAV vector in August 2025, which led to severe activation of the complement system and cytokines, rapidly progressing to acute respiratory distress syndrome (ARDS), and ultimately resulting in death despite resuscitation efforts
.
more.....zhttps://k.sina.com.cn/article_5953189932_162d6782c06704ugc8.html?cre=tia nyi&mod=pcpager_news&loc=19&r=0&rfunc=28&tj=cxvert ical_pc_pager_news&tr=174
Link to original STAT report:
Once again, child dies in gene-editing trial in China, rekindling debate on transparency and safety
https://www.statnews.com/2026/08/05...ty-safety-questions-investigator-led-studies/