Shanghai gene-editing trials linked to two pediatric deaths

Investigative reports have revealed two separate deaths of pediatric patients in Shanghai linked to gene-editing clinical trials.

In the first case, the biotech startup HuidaGene conducted a clinical trial for a CRISPR/Cas12 therapy (HG302) targeting Duchenne muscular dystrophy (DMD). Following a significant increase in dosage to approximately 100 trillion viral particles per kilogram of body weight, a male patient developed a severe cytokine storm and acute respiratory distress syndrome (ARDS), leading to death. HuidaGene later issued a statement confirming the death was caused by an immune response, though critics noted the company failed to report the incident promptly, with the news only surfacing through international media investigations.

The second incident involved a six-year-old girl who died in March 2024 following gene-editing treatment at Xinhua Hospital. It has been alleged that the research team omitted the child's death and the details of the trial from subsequently published academic papers to present a false impression of the therapy's safety and efficacy.