The US National Institutes of Health (NIH) restricts funding for research that destroys human embryos, so Mitalipov had to do his work with money from private sources, and in a “mirror laboratory” that shared no resources with his NIH-funded research. However, work in the clinic will create eggs that are not meant to be destroyed, so might be eligible for public money. “Now the questions is: will the NIH fund the clinical research?” asks a somewhat exasperated Mitalipov.
Before the technique can be used in the clinic in the United States, it must be approved by the US Food and Drug Administration, which has asserted its authority over reproductive technologies. Mitalipov submitted an application for approval in January, but has so far received no response. “The ball is on their side of the court,” he says. “We just want their guidance. Unfortunately the patients are waiting.”
Approval could be a long time coming: the public and legislators are wary of creating hybrid “three-parent babies”. The technique does mix genetic material from a mitochondria donor, the mother who provides the nucleus and a father. That mix will remain in any descendants.
In the United Kingdom, things might move faster. A team at Newcastle University has conducted similar experiments, and authorities have been considering their stance on the technology. An independent regulator, the Human Fertilisation and Embryology Authority, launched a public consultation in September.
Once approved, the technology could spread quickly. Mitalipov says the most complex apparatus involved is a microscope and lasers for drilling into the egg, which are already commonly used in fertility clinics as part of in vitro fertilization techniques and preimplantation genetic testing. “The clinics will learn. It shouldn’t be difficult to master,” he says.