The Wall Street Journal: Artificial Wombs for Premature Babies Are a Step Closer to Reality
By Liz Essley Whyte
The first artificial womb to gestate a human baby is fast approaching reality.
Food and Drug Administration regulators will weigh next week how scientists should conduct the first human tests of bag-like wombs, meant to nurture babies born so premature that modern medicine struggles to keep them healthy.
The agency plans to meet with outside advisers and discuss behind closed doors what the agency called “confidential commercial information,” citing a federal law that allows nonpublic meetings to discuss trade secrets. The agency hasn’t disclosed which company’s work will be discussed.
Philadelphia-based Vitara Biomedical has said that it is working on an artificial womb and is close to human clinical trials. A company executive said at a biotech symposium last year that the firm is commercializing the research of one of two U.S. groups known to be testing the technology on lambs. The other U.S. group says it is still a few years off from human trials.
Any tests on human babies would need signoff from the FDA, and the agency often meets with outside advisers before high-profile decisions. Tests would require approval from a committee charged with protecting humans in scientific tests, known as an institutional review board.
Dr. Stephanie Kukora, a neonatologist at Children’s Mercy Kansas City who has written about the ethics of testing artificial wombs, said launching trials will require answering several ethical conundrums, including how best to counsel families about the risks of being among the first to put their babies into artificial wombs.
“It would be a really hard decision. The odds aren’t great with conventional therapy, but we at least sort of know what they are,” Kukora said. “I don’t know what I would do.”
Read the full article via The Wall Street Journal