The Quest to Bring Artificial Wombs to Humans: An FDA Advisory Committee Meeting

Sunday - October 1 2023, 08:59 UTC - 1 year ago

The US Food and Drug Administration held an advisory committee meeting to discuss plans to move artificial womb technology out of the lab and into first-in-human clinical trials. It has been tested with hundreds of lambs and the potential application has widely discussed. The procedure requires a cesarean section followed by an immediate transfer into a "biobag.".

On September 19, US Food and Drug Administration advisors met to discuss how to move research on artificial wombs from animals into humans. These medical devices are designed to give extremely premature infants a bit more time to develop in a womblike environment before entering the outside world. They have been tested with hundreds of lambs (and some piglets), but animal models can’t fully predict how the technology will work for humans. "The most challenging question to answer is how much unknown is acceptable," said An Massaro, FDA’s lead neonatologist in the Office of Pediatric Therapeutics, at the committee meeting. That’s a question regulators will have to grapple with as this research moves out of the lab and into first-in-human trials.

An artificial womb is an experimental medical device intended to provide a womblike environment for extremely premature infants. In most of the technologies, the infant would float in a clear "biobag," surrounded by fluid. The idea is that preemies could spend a few weeks continuing to develop in this device after birth, so that "when they’re transitioned from the device, they’re more capable of surviving and having fewer complications with conventional treatment," says George Mychaliska, a pediatric surgeon at the University of Michigan.One of the main limiting factors for survival in extremely premature babies is lung development. Rather than breathing air, babies in an artificial womb would have their lungs filled with lab-made amniotic fluid, that mimics the amniotic fluid they would have had just like they would in utero. Neonatologists would insert tubes into blood vessels in the umbilical cord so that the infant’s blood could cycle through an artificial lung to pick up oxygen.

The device closest to being ready to be tested in humans, called the EXTrauterine Environment for Newborn Development, or EXTEND, encases the baby in a container filled with lab-made amniotic fluid. It was invented by Alan Flake and Marcus Davey at the Children’s Hospital of Philadelphia and is being developed by Vitara Biomedical.The technology used in the EXTEND system has been tested on lamb fetuses, about 300 so far, with good results. The lambs can survive and develop inside the sack for three or even four weeks.

To move forward with human testing, the company needs an investigational device exemption from the FDA. At a meeting in June, Flake said Vitara might be ready to request that exemption in September or October. But at the September advisory committee meeting, when Flake was directly asked how far the technology had advanced he declined to answer. He said he could discuss timing with the advisory committee during the portion of the meeting that was closed to the public. To greenlight a trial, FDA officials need to be convinced that babies who try EXTEND are likely to benefit from the system, and that they’ll fare at least as well as babies who receive the current standard of care.

The procedure requires a carefully choreographed transfer. First, the baby must be delivered via cesarean section and immediately have tubes inserted into the umbilical cord before being transfer into the "biobag." .