In a first for the United States, a clinic has delivered a healthy baby from the transplanted uterus of a deceased donor.
It's a promising development in reproductive options for women who are infertile due to uterine problems, according to the research team behind the delivery.
The girl was born in June via cesarean section to a patient in her mid-30s, said the Cleveland Clinic, which performed the transplantation and birth.
The patient was born without a uterus and entered the clinic's trial for women with uterine factor infertility, said Dr. Tommaso Falcone, a member of the transplant team. Women with this condition either are born without an intact uterus or have had uterine damage through an infection, procedure or hysterectomy.
The unnamed patient elected to remove the transplanted uterus after the birth, he said.
"This was always a question mark that required research," he said. "But this goes to the idea that a deceased donor can give her uterus, and it will function amazingly well."
The process took 15 months
It's the second time that physicians have delivered a baby from a woman with a transplanted uterus from a deceased donor. The first occurred in 2017 in a Brazilian trial involving a 32-year-old woman born without a womb who received a uterine transplant from a 45-year-old woman who'd died of a stroke.
The Cleveland Clinic trial accepts donor uteruses only from premenopausal women, ages 18 to 40, though Falcone noted that the uteruses of living postmenopausal women have been successfully transplanted in separate trials.
The process for this patient took about 15 months from transplantation to birth, he said. Her pregnancy was "not excessively complicated," and she was able to leave the hospital within three days of her C-section.
The trial involves seven phases
The process for trial candidates can be lengthy, spanning seven phases: Women are screened twice for their medical history. Then, they must obtain medical clearance. If they're viable candidates, they can begin the in vitro fertilization process, removing eggs from the candidates' ovaries and mixing them with the fathers' sperm to provide sufficient embryos for implantation.
Next comes womb transplantation. In this patient's case, a team retrieved the uterus from the deceased donor and took it back to the hospital, where it was transplanted.
Patients are given immunosuppressive drugs in post-op to prevent their body from rejecting the foreign uterus. The team studied pregnant women who underwent kidney and liver transplants and the way their bodies reacted to those anti-rejection drugs to ensure the safety of the patient, he said.
If all goes well, as it did in this instance, the patient completes the trial with the birth of a healthy infant.
It's a delicate balancing act
A deceased donor presents a unique set of challenges. In a living donor transplant, Falcone explained, surgeons are able to immediately to transfer a uterus to the recipient, usually in an operating room only steps away.
Physicians remove the lifesaving organs, like the heart, liver and kidney, from a deceased donor before they can remove "life-enhancing" organs such as the uterus, he said, so they maintain a balancing act to ensure that neither set is compromised during removal.
It was a gamble, he said, because the team wasn't sure whether the uterus would remain viable after its extraction.
There's a risk of rejection
With both living and nonliving donors, there's a persistent risk that the patient's body will reject the transplanted uterus. The leading cause of previous failed uterus transplants is thrombosis, or blood clotting in the transplanted womb, followed by infection, Falcone said.
Less than a month after the Cleveland Clinic performed the first uterus transplant in the nation in 2016, physicians removed the organ from the 26-year-old patient due to a sudden complication, the clinic said.
Falcone said researchers study such factors as the position of the uterus upon implantation and when infection was spotted to prevent future mistakes. But because the procedure is still experimental, teams studying uterus transplants lean on each other to solve problems.