Phase 2 for fu­ture of fer­til­ity

Bay­lor hospi­tal moves for­ward with trial for uterus trans­plants

The Dallas Morning News - - Front Page - By SARAH SARDER Staff Writer [email protected]­las­news.com

Doc­tors at Bay­lor Univer­sity Med­i­cal Cen­ter at Dal­las have be­gun the sec­ond phase in the trial of a feat once con­sid­ered im­pos­si­ble: trans­plant­ing a womb.

With trans­plant candi­ dates cho­sen and fund­ing se­cured, a mas­sive team of doc­tors and sur­geons is hon­ing the com­plex pro­ce­dure that can al­low in­fer­tile women — pre­vi­ously lim­ited to adop­tion or sur­ro­gacy — to give birth.

Their first suc­cess with the pro­ce­dure came in 2017, when Bay­lor doc­tors de­liv­ered the na­tion’s first baby born from a trans­planted uterus. Now a 1year­old, that in­fant is on Time mag­a­zine’s Jan­uary cover about the fu­ture of ba­bies.

Dr. Gi­u­liano Testa, chief of ab­dom­i­nal trans­plan­ta­tion at Bay­lor and prin­ci­pal in­ves­ti­ga­tor for the trial, said the pro­ce­dure is po­ten­tially more eth­i­cal than sur­ro­gacy, in which some­one other than the mother as­sumes the risk of preg­nancy.

“Some of us think this is the most nat­u­ral op­tion if you want re­ally to have your own ge­netic self given to your kids,” he said.

Despite the pro­ce­dure’s suc­cess and the sur­round­ing pub­lic­ity, the re­sponse hasn’t all been pos­i­tive.

Dr. Liza Jo­han­nes­son, med­i­cal direc­tor for the Bay­lor trial, was part of the team that de­liv­ered the world’s first baby from a trans­planted uterus in 2014 in Swe­den — some­thing she said crit­ics didn’t be­lieve could be done. Once the Swedish team suc­ceeded, she said, the crit­i­cism

shifted to eth­i­cal con­cerns.

Dr. Louise King, direc­tor of re­pro­duc­tive bioethics at Har­vard Med­i­cal School’s Cen­ter for Bioethics, said sig­nif­i­cant work re­mains to be done be­fore pro­fes­sion­als can ar­rive at any eth­i­cal judg­ment on uterus trans­plants, as just 13 ba­bies have been born world­wide from the pro­ce­dure. Two of those ba­bies were born in the U.S., at Bay­lor.

Chief among her con­cerns are the cre­ation of stan­dards to de­ter­mine which med­i­cal fa­cil­i­ties can per­form the pro­ce­dure and how the process would be fi­nanced.

A new pos­si­bil­ity

One in 500 women ex­pe­ri­ences ab­so­lute uter­ine in­fer­til­ity, a re­quire­ment for get­ting the trans­plant.

The prepa­ra­tion for the pro­ce­dure be­gins with in vitro fer­til­iza­tion, which man­u­ally com­bines a sperm and an egg to cre­ate an em­bryo. With a frozen em­bryo at the ready, pa­tients re­ceive a uterus trans­plant. Then, they wait.

Women with trans­planted uteruses must stay on im­muno­sup­pres­sants to avoid or­gan re­jec­tion, but the med­i­ca­tion leaves them more vul­ner­a­ble to dis­ease. Af­ter three to six months, when the woman is at the right level of im­muno­sup­pres­sion, the em­bryo can be trans­ferred into the uterus.

When Tay­lor Siler, 37, saw a post from Bay­lor seek­ing donors for uterus trans­plants, she was in­cred­u­lous — as a nurse, she knew the pro­ce­dure was un­heard of. Siler, a mother of two young boys, had con­sid­ered sur­ro­gacy but de­cided it would be too dis­rup­tive to her fam­ily. With a sim­pler process on the ta­ble, she con­tacted Bay­lor for screen­ing.

Af­ter a months­long process in­volv­ing lab work, ra­di­ol­ogy tests, psy­cho­log­i­cal eval­u­a­tions and ex­ten­sive pa­per­work, trial of­fi­cials asked Siler to donate. It wasn’t un­til De­cem­ber 2017, more than a year af­ter she un­der­went a hys­terec­tomy, that Siler met the re­cip­i­ent — and her new­born in­fant, the first born as part of the pro­gram.

“It was re­ally awk­ward, like go­ing on a first date,” Siler said. “But see­ing her and hold­ing him, it was only sec­ond to hold­ing my own kids for the first time.”

The par­ents of that child spoke with The Dal­las Morn­ing News about their ex­pe­ri­ence but wished to re­main anony­mous to pro­tect the fam­ily’s pri­vacy.

“I’m happy and lucky to be hav­ing sleep­less nights with the baby,” the mother said, chok­ing up. “He’s a mir­a­cle.”

‘It’s sci­ence fic­tion’

Siler’s hus­band, Clint Siler, said mea­sur­ably proud” of his wife.

“It was beyond self­less of her to go un­der the knife and to do some­thing that wasn’t needed to save a life,” he said.

But Ben­jamin Berk­man, a bioethi­cist at the Na­tional In­sti­tutes of Health, said the use of live donors brings up eth­i­cal con­cerns be­cause the pro­ce­dure isn’t life­sav­ing, man­dat­ing a dif­fer­ent kind of anal­y­sis than other trans­plants.

“This new tech­nol­ogy is amaz­ing. It’s sci­ence fic­tion in some ways,” Berk­man said. “But we’re a long way off from it ac­tu­ally be­com­ing com­mon pro­ce­dure.”

Jo­han­nes­son, how­ever, be­lieves uter­ine trans­plants are be­com­ing a more vi­able op­tion with each day of the trial.

“In five, 10 years down the road, we are ready to of­fer this for sure as a stan­dard pro­ce­dure,” she said.

The big­gest is­sue, Jo­han­nes­son said, lies in find­ing the fund­ing for trans­plants. Bay­lor is foot­ing the bill for ev­ery­thing but IVF for trial pa­tients, and all of the core team mem­bers are he’s “im­ work­ing pro bono, so there is no over­all cost es­ti­mate for the trans­plant and preg­nancy.

Bay­lor Scott & White spokes­woman Julie Smith said the trans­plant costs about the same as a kid­ney trans­plant — around $200,000 — but that can vary depend­ing on the in­sti­tu­tion and pa­tient. Be­cause a uterus trans­plant is an elec­tive pro­ce­dure, in­sur­ance poli­cies are un­likely to cover the cost.

Charles Bur­ton, an As­so­ci­a­tion for Med­i­cal Ethics board mem­ber, said the dan­ger ex­ists that the trans­plants could be per­formed ex­ces­sively once they’re more com­mon­place.

“The eth­i­cal is­sues are pretty straight­for­ward,” Bur­ton said. “It’s the eco­nomic is­sues that will be the real chal­lenge.”

Look­ing ahead

Doc­tors and re­searchers at Bay­lor be­gan work on the first phase of the trial in 2016. To date, more than 1,000 po­ten­tial re­cip­i­ents and 400 po­ten­tial donors have con­tacted Bay­lor, Smith said. Med­i­cal pro­fes­sion­als chose 20 women, 10 in each phase of the trial, to re­ceive trans­plants.

The trans­planted uteruses are re­moved af­ter women have one or two chil­dren, in or­der to avoid keep­ing them on im­muno­sup­pres­sants any longer than nec­es­sary. Be­cause the trial’s re­cip­i­ents have hor­mone­pro­duc­ing ovaries, trans­plant­ing and later re­mov­ing a uterus has no ma­jor neg­a­tive ef­fects on their bod­ies, doc­tors say.

The suc­cess of uter­ine trans­plants has ig­nited hope that the pro­ce­dure could help trans­gen­der women carry chil­dren as well, but ovaries are just one of the fac­tors that com­pli­cate that pos­si­bil­ity. Testa and Jo­han­nes­son would not rule out the pos­si­bil­ity of an equiv­a­lent pro­ce­dure even­tu­ally be­ing de­vel­oped for trans women — af­ter all, a few years ago, many con­sid­ered uterus trans­plants im­pos­si­ble.

The trans­plant was life­chang­ing for the fam­ily of the first baby born in the trial, and his par­ents said they’re op­ti­mistic that it will of­fer hope to oth­ers.

The doc­tors said they want to share what they’ve learned with other med­i­cal in­sti­tu­tions and make the pro­ce­dure more com­mon and ac­ces­si­ble. In May, they will at­tempt to do so at a uterus trans­plant sum­mit at Bay­lor.

Shan­non Faulk/bay­lor Scott & White

A baby born to a woman who had a uterus trans­plant rested on her mother at Bay­lor Univer­sity Med­i­cal Cen­ter at Dal­las, which is con­duct­ing tri­als of the pro­ce­dure.

Sha­ban Athu­man/staff Pho­tog­ra­pher

Dr. Gi­u­liano Testa is prin­ci­pal in­ves­ti­ga­tor and Dr. Liza Jo­han­nes­son is med­i­cal direc­tor for tri­als of uterus trans­plants at Bay­lor Univer­sity Med­i­cal Cen­ter.

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