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China slows controversial sickle cell gene therapy trials after patient deaths

New government restrictions in China have slowed investigator-initiated trials for sickle cell gene therapy following reports of recent patient deaths.

STAT+: A possible comeback for a failed sickle cell gene therapy
File photo STAT+: A possible comeback for a failed sickle cell gene therapy Photo: STAT

Regulatory changes halt fast testing routes

China previously allowed a fast and cheap route to human testing for biotech companies. Recent government restrictions have considerably slowed investigator-initiated trials in the country. These changes affect U.S. biotechs that wanted to bypass lengthy development timelines.

Safety concerns impact trial speed

News of recent patient deaths has contributed to the slowdown in these clinical studies. Investigators are now proceeding with considerably less speed than before the new rules. This shift impacts the broader landscape of human testing for gene therapies.

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