Hanley could not raise money for his company Butterfly Sciences and decided to obtain proof of concept by testing gene therapy on himself. Hanley said: "
I wanted to prove it, I wanted to do it for myself, and I wanted to make progress." He said that he corresponded with the
FDA prior to starting his
self-experimentation, and that the FDA told him he needed to file and get approval for an
Investigational New Drug (IND) application, but Hanley did not agree that he needed FDA approval and proceeded without it.''' He did not perform any animal tests before testing the plasmid on himself, but won
institutional review board (IRB) approval regardless on his proposed clinical research plans. Hanley claims the treatment has helped him. He reported that his white blood cell count and testosterone increased and his LDL levels dropped. A researcher at
George Church's
Harvard University laboratory observed the experiment and Hanley's blood was then studied. The scientific results were published in December 2021, coauthored with George Church. == Transgender research ==