[Reading Science] Artificial Womb to Save One Million Premature Babies... Human Trials Imminent

US FDA to Review Approval at Advisory Committee Meeting on 19-20, Drawing Attention

Artificial womb technology that saves the lives of newborns in danger due to preterm birth is expected to begin full-scale human trials. It is drawing attention as it could significantly reduce the nearly one million newborn deaths worldwide each year.

Sheep grown in an artificial womb (biobag) developed by a research team at the Children's Hospital of Philadelphia, USA. Photo by YouTube capture.

On the 14th (local time), the international academic journal Nature reported that the U.S. Food and Drug Administration (FDA) will hold an advisory committee meeting on the 19th and 20th to discuss whether to approve human trials of the artificial womb developed by the research team at the Children's Hospital of Philadelphia. If the FDA grants approval, clinical application of the related technology could accelerate rapidly.

The research team previously succeeded in an animal experiment in 2017, where they kept preterm lambs alive in an artificial womb. The artificial womb developed for human trials this time is named "EXTEND" (Extra-uterine Environment for Newborn Development). It is not capable of performing the entire fetal development process from pregnancy to birth like a human uterus. According to the research team, it is a device that performs some functions such as life support and nutrition supply to help sustain the survival and growth of extremely preterm infants. Human newborns are usually born between 37 and 40 weeks of gestation, but if born before 28 weeks, which is less than 70% of this period, the device can help maintain life and promote growth to an appropriate level.

The World Health Organization (WHO) defines preterm birth as delivery before 37 weeks of gestation. It occurs when conditions such as viral infections, hormonal imbalances, high blood pressure, or diabetes create an environment in the uterus where the fetus can no longer survive. Preterm birth is a major health and medical issue worldwide, being the leading cause of disability and death among children under five years old. In 2020, approximately 13.4 million preterm infants were born worldwide, and as of 2019, about 900,000 newborns died due to complications related to preterm birth.

Newborn mortality rates are especially influenced by the gestational age at birth. Survival rates are nearly zero if the fetus is born before 22 weeks, while most survive if born after 28 weeks, although many require life support devices. Additionally, preterm infants have a higher likelihood of suffering from various disabilities and diseases. A study conducted in Sweden on about 2.5 million people found that 78% of those born before 28 weeks had experienced treatment for various diseases such as asthma, hypertension, epilepsy, and cerebral palsy by adulthood. In contrast, this rate dropped to 37% for those born at full term. This is because the lungs and brain are the last organs to mature in human newborns, which is why obstetricians strive to prevent preterm birth whenever possible. The longer the fetus remains in the uterus, the lower the risk of disabilities and the better the chances of long-term healthy survival.

In the mother's uterus, fetuses receive oxygen, nutrients, antibodies, and hormonal signals through the placenta and expel waste products. Artificial womb technology focuses especially on safely supplying oxygen and removing carbon dioxide for preterm infants born between 22 and 28 weeks. Mechanical ventilators, which are often used for newborns, can damage the underdeveloped lungs, so replacing them is a key function of this technology.

This content was produced with the assistance of AI translation services.