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Shanghai authorities on Friday released the findings of an investigation into a gene-editing research case at Shanghai Jiao Tong University School of Medicine, following a report by the journal Science that a child died after taking part in a clinical study at Xinhua Hospital. The investigation found that the researchers failed to promptly disclose the child's death when publishing their paper in Nature in February 2026, according to CCTV News.

The child was diagnosed with Snijders Blok-Campeau syndrome, a rare neurodevelopmental disorder for which no effective treatment is currently available. After seeking treatment at several major hospitals without success, the child's family contacted a researcher surnamed Qiu at Shanghai Jiao Tong University School of Medicine's Songjiang Research Institute in July 2023, hoping to work with Qiu to develop a customized gene-editing therapy targeting the central nervous system. 

Qiu's team subsequently conducted preclinical research. On January 2, 2025, Xinhua Hospital's ethics committee approved the clinical study. The child and family signed an informed consent form on February 20. The child received an injection at the hospital on March 24 but died on March 31 despite resuscitation efforts. The hospital's ethics committee later determined that the death was caused by thrombotic microangiopathy, a complication of gene therapy, and called for the study to be terminated.

The investigation found that the preclinical research team led by Qiu failed to strictly comply with relevant rules and procedures during the research process.

Qiu's team failed to promptly inform the hospital's clinical study leader of safety findings from non-human primate experiments, resulting in warning signals in the safety report not receiving due attention. The team also failed to promptly disclose the findings of the non-human primate safety report completed in February 2025, as well as the adverse clinical outcome of the child's death, when publishing the paper, according to CCTV News. 

Investigators found no evidence of data fabrication in the Nature paper, but identified academic irregularities, including inconsistencies between the actual research methods and those reported in the paper, and the unexplained presentation of data from the same batch in multiple stages

The investigation also found deficiencies in Xinhua Hospital's scientific and ethical reviews. Its ethics committee approved the clinical study despite insufficient toxicological and safety evidence and the research team's failure to submit the requested supplementary materials. Although the informed consent form disclosed the possibility of serious complications and adverse events, it did not specifically emphasize the risk of death.

The child's family provided 5.337 million yuan (about $800,000) in research funding through donations and gave cash and gifts worth approximately 1.06 million yuan to several individuals involved in the research. The cash and gifts have since been returned or turned over in accordance with relevant regulations.

Two researchers surnamed Qiu and Yang were dismissed and barred for five years from undertaking or participating in science and technology programs and from receiving awards and honors. Both were also placed in the database of serious research integrity violations. Other personnel received disciplinary penalties, while involved hospitals were subjected to administrative penalties.

Shanghai authorities have also launched special inspections and rectification efforts involving clinical research into new biomedical technologies, emphasizing the high risks associated with clinical studies involving such technologies as cell and gene therapies and the need for stronger oversight.

Global Times