Artificial Womb

choi

Liz Essley Whyte, FDA to Weigh Artificial Wombs for Preemies. Wall Street Journal, Sept 14, 2023, at page A 3.
https://www.wsj.com/health/fda-a ... cal-trials-fcb923a4

Note:
(a)
(i) In print, the article ends with the paragraph that starts with, "The FDA said in its meeting notice
(ii) One should not hold much hope until a new procedure or drug is tested among many humans. The biotech company is seeking FDA approval to start clinical trials.
(b) preemie (n; variants or less commonly premie; from premature + ie):
https://www.merriam-webster.com/dictionary/preemie

My guess is that the insertion of an e is to ensure correct pronunciation of the first e.
(c) The forty-week gestation starts from the beginning of the last menstruation. This is obsterics, using a marker that everybody can notice. See gestation
https://en.wikipedia.org/wiki/Gestation
("Clinically, pregnancy starts from first day of the mother's last period. * * * Human pregnancy can be divided into three trimesters, each approximately three months long: the first, second, and third trimester. The first trimester is from the last menstrual period through the 13th week, the second trimester is 14th–28/29th week, and the third trimester is 29/30th–42nd week. Birth normally occurs at a gestational age of about 40 weeks, though it is common for births to occur from 37 to 42 weeks. Labor occurring prior to 37 weeks gestation is considered preterm labor")
And this is also the marker abortion uses, including law on abortion. So when a woman misses the next menstruation, by law she is already four weeks pregnant, though only two weeks after fertilization.

In embryology, a gestation occurs from the moment an egg is fertilized (which nobody can tell, unless a scientist observes it).
(d) "The product is based on the research of a Children's Hospital of Philadelphia group led by Dr Alan Flake * * * [whose] research went viral in 2017 when the group published pictures of the lambs, which showed the fetuses lying on their sides in the artificial wombs while various tubes connected to them helped provide all the necessary fluids and oxygen to keep them alive."
(i) Children's Hospital of Philadelphia
https://en.wikipedia.org/wiki/Ch ... tal_of_Philadelphia
(1855- ; acronym: CHOP; CHOP has been ranked as the best children's hospital in the United States)

Though affiliated with Univeristy of Pennsylvania (which is private), CHOP is an independent, private, non-profit organization with its own board of trustees (but its staff pedistricians are jointly appointed by Department of Pediatrics, U Penn). CHOP's website states at "About": "Children's Hospital of Philadelphia (CHOP) is the nation's first hospital devoted exclusively to the care of children."
(ii) Alan W Flake, MD, FACS, FAAP
https://www.chop.edu/doctors/flake-alan-w
, where FACS and FAAP means Fellow of American College of Surgeons and Fellow of the American Academy of Pediatrics, erespectively.
(iii) Partriage EA et al (last author is Dr Flake), An Extra-Uterine System to Physiologically Support the Extreme Premature Lamb. Nature Communications, 8: 15112 (2017)

text: "The longest runs were terminated at 28 days due to animal protocol limitations rather than any instability, suggesting that support of these early gestational animals could be maintained beyond 4 weeks.

Please read Abstratc and Introduction in addition.


------------------------------------
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.

Vitara didn’t respond to inquiries from The Wall Street Journal, and a scientist involved with the company declined to comment.

Vitara’s artificial womb looks like a plastic bag with connected tubes—some to deliver fresh amniotic fluid and others to provide oxygen and medications to the fetus through its umbilical blood vessels, according to published research. Scientists have said they aim for it to nurture premature babies born at 23 to 25 weeks of gestational age, allowing their lungs to develop at least several more weeks in the fluid environment so helpful to their growth.

Underdeveloped lungs are the largest problem very premature babies face, neonatologists say, and the best current treatment—putting the tiny patients on ventilators—can cause severe damage.

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.

About one in 10 babies in the U.S. is born prematurely—before 37 weeks’ gestation—but less than 1% of babies are born extremely prematurely, before 28 weeks, according to data from the Centers for Disease Control and Prevention.

The wombs would require removing babies from their mothers by caesarean section and immediately placing them into the bags before their umbilical blood vessels constrict, as would happen normally in birth, scientists have said.

Parents would have to weigh the risks of the device—which could include life-threatening infection, brain damage and heart failure, scientists have said—against the risks of conventional treatment. Currently about half of babies born at 23 weeks die, and about a third of those who survive have severe neurodevelopmental delays by around age 2, a 2022 JAMA study found.

Vitara leaders have said the FDA designated their technology a “breakthrough therapy,” which means the agency will aim to decide more quickly whether to approve the company’s product and speak with company scientists more often about what tests will be required.

The product is based on the research of a Children’s Hospital of Philadelphia group led by Dr. Alan Flake, who declined to comment. The research went viral in 2017 when the group published pictures of the lambs, which showed the fetuses lying on their sides in the artificial wombs while various tubes connected to them helped provide all the necessary fluids and oxygen to keep them alive.

Flake has said he doesn’t expect his device will change the limit of viability, which currently hovers between 21 and 22 weeks and in the past has guided many abortion debates. It would be too difficult to get the artificial womb to work correctly for even smaller babies, he has said.

The FDA said in its meeting notice that the discussion would be limited to the use of the technology as an alternative to the current standard treatments for extremely premature babies.

Flake and his fellow researchers have referred to potential future residents of their artificial womb as “fetonates”—a portmanteau of “fetus” and “neonate”—since they will leave their mothers’ bodies but will still have some of the physiology of a fetus, such as blood flow that bypasses the lungs.

Scientists at the University of Michigan are developing similar technology—an “artificial placenta”—meant to be used on babies who are placed inside incubators already used in hospitals’ neonatal intensive care units.

Dr. George Mychaliska, who leads the Michigan effort, said he expects to begin clinical trials within the next three years.

A group of researchers in Singapore, Australia and Japan have their own womb-like device called the EVE system. A scientist working on the project said he thinks their own device and any others are at least five to 10 years away from clinical trials, especially since standard neonatal care continues to improve and makes the case for trying experimental therapies harder.

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.