ASGCT Statement on Germline Gene Editing Practices

Germline gene editing and the implantation of gene-edited embryos to achieve a pregnancy are technologies that are not ready for use in humans, or allowed by current law in the United States and many countries. The American Society of Gene & Cell Therapy (ASGCT) considers it wholly unacceptable to use these technologies without extensive research into the safety and efficacy of such applications, and the necessary approval by regulatory and government bodies. Any announcements of, or claims to have begun, such studies in germline gene editing are compromised, both ethically and scientifically.

Germline editing is the application of gene editing technologies to germline cells (eggs and sperm) or fertilized embryos, which can pass on their genetic information to future generations. The United States prohibits federal funding for any research that includes editing in human embryos. All gene therapies, including gene editing, fall under FDA regulation in the United States. Under current law, the FDA is prohibited from considering clinical trial applications in which a human embryo is intentionally created or modified to include a heritable genetic modification. ASGCT continues to monitor the status of gene editing science and contributes to the debate around its possible applications.

ASGCT condemns any action, scientific or otherwise, that occurs outside of established laws and regulations.

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