Baylor University Medical Center last week announced plans to become the third hospital in the country to deliver a healthy baby with a transplanted uterus.
The forthcoming clinical trial will include 10 women between the ages of 20 and 35 who either have a nonfunctioning uterus or lack one entirely. Called absolute uterine factor infertility, it affects an estimated 1 million American women—about 15 percent of the country’s female population of 62 million. The 10 women must have intact ovaries and a desire to have either one or two children. Prior to studies like these, the only options these eligible women had would be to adopt or find a surrogate.
“The success here is not the transplant,” said Dr. Goran Klintmalm, the chief and chairman of Baylor’s Annette C. And Harold C. Simmons Transplant Institute. “The success here is the birth of a healthy baby.”
Klintmalm, the man who launched Baylor’s transplant program 31 years ago, has kept a close eye on uterine transplantation. The legendary Swedish surgeon and researcher has a longstanding relationship with Sweden’s University of Gothenburg. And so when a patient who had a uterus transplanted by Gothenburg’s surgeons gave birth to a healthy baby in October of 2014, Klintmalm said he knew Baylor could eventually do the same thing. What resulted was this clinical trial, modeled closely after the procedures established in Sweden.
This is new territory for medicine. And as such, the Baylor Scott & White Research Institute will carefully screen candidates to find what they consider optimal—not too heavy and not too thin, no co-morbidities or any history of major medical procedures. If the trial is a success, then researchers will be able to try more complex patients, but that’s far off.
“Everything we do is based on the experiments done at the University of Gothenburg for the last 15 years,” Klintmalm said. “This is what we did in kidney transplantation 60 years ago, and what we did in liver transplantation 50 years ago, 40 years ago. We have to figure out how to do it safely before we can start expanding upon it.”
The Cleveland Clinic is the first American center to pursue uterine transplantation, announcing its initiative last November. The University of Nebraska Medical Center followed in December. Those studies are only using deceased donors to contain the risk to one patient. Baylor is different in that it will accept living donors in addition to deceased. Sweden’s success came with living donors, five of whom were the woman’s own mother—meaning that the daughter would give birth through the very womb they were born from. (In all, the Swedish have transplanted nine uteruses, resulting in five live births.)
Although, the doctors made clear that deceased donors would only be used if a suitable living donor was not available. To donate their uterus, the woman must be between 40 and 65 years old and have carried at least one baby to term. There are plenty of questions regarding deceased donors, including the ischemic time for a uterus—the amount of time spent outside the body that the organ is viable. Dr. Giuliano Testa, the principal investigator and surgical chief of abdominal transplantation at Baylor, said they will use the same policy as it comes to hearts: It will spend no more than four to six hours outside of a body before transplant.
“They seem to be fairly resilient to injury with time, but the only studies we have are not human studies, so one of the things that Dr. Klintmalm properly said at the beginning: we are going sometimes into uncharted waters,” Testa said. “In the beginning we will be very safe, I can tell you we will keep that as we do with heart transplantation which is within four hours of transplant, and I think that’s a very safe approach.”
The way the procedure will work: The hopeful mother’s eggs will be frozen and stored until a suitable donor becomes available. After the womb is transplanted, the doctors will wait about one year to implant the embryos and the baby will be carried until it’s close to term. Doctors will perform a C-section a few weeks before the due date. The woman then has the choice to either remove the uterus or attempt to give birth to a second child. The woman will take immunosuppressive drugs until the uterus is taken out.
Testa repeated a saying during the press conference on Friday: “This is not a life saving procedure. This is a life-giving procedure.” And that’s true. These women would not die without a uterus. In the past, transplants have been the last grasp at life for people with end stage organ failure. The procedure is highly invasive; what are the ethics of putting a woman through that who doesn’t absolutely need it?
Testa said this was the first thing he questioned. There were three ethics reviews: First from Baylor’s ethics committee, then to the ethics review board, and a third by the hospital’s leadership. There was no opposition, Klintmalm said.
“We know what the risks of immunosuppresion are, we know what the risks of surgery are,” Testa said. “So as long as the risks are known and the person can make an autonomous decision regarding undergoing the procedure we are respecting the ethical principal that is driving medicine today, which is autonomy and respect for human beings.”
The screening process will begin immediately. Patients do not have to be from the Dallas-Fort Worth Area, but they must be willing to relocate here for the entire process. The first baby born from the study is expected to arrive in 2017.