For the first time in history, scientists have successfully implanted lab-grown vaginal organs in human patients.
The organs, grown with the patients’ own tissue, were implanted between June 2005 and October 2008 in four teenage girls who each lacked or had an underdeveloped vagina and uterus, the result of a rare genetic condition called Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome.
Years after the two-hour procedures, annual follow-up visits showed that the surgeries had been a success: The new organs functioned normally, including during sex, and their tissue was indistinguishable from the native tissue that had already been there.
The findings offer hope not only for those with MRKH syndrome, but also for those suffering from vaginal cancers or injuries.
“This pilot study is the first to demonstrate that vaginal organs can be constructed in the lab and used successfully in humans,” said Dr. Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine, which took part in the procedures. “This may represent a new option for patients who require vaginal reconstructive surgeries. In addition, this study is one more example of how regenerative medicine strategies can be applied to a variety of tissues and organs.”
If ultimately approved by the FDA – a prospect that still remains years away – the operation may even become an option for men seeking a sex change.
The process was carried out by specialists from medical centers in both the U.S. and Mexico. First, doctors took a biopsy of each patient’s external genitals, extracting muscle and epithelial cells, or cells that line the body’s cavities.
They then sent the samples to a manufacturing facility, where the cells were expanded and placed on biodegradable material that was hand-sewn “into a vagina-like shape,” each “tailor-made” to fit each patient, a release on the findings said.
Previous research in Atala’s lab had shown that once these so-called “scaffolds” are implanted in the body, blood vessels and nerves form and cells expand to create tissue. The cells also build a “permanent support structure – gradually replacing the engineered scaffold with a new organ,” the release said.
Surgeons carried out this part of the procedure five or six weeks after the biopsies. At the HIMFG Tissue Engineering Laboratory in Mexico City, which has a partnership with the Wake Forest medical center, they carved a canal in the patients’ pelvises, then sutured the scaffolds to their reproductive structures.
It’s similar to the methods Atala and his team used to build replacement bladders for nine children starting in 1998, and implant lab-built urethras in young boys. And it worked. ??????????
“They now have their own organ, made out of their own tissue, so the body did recognize it as being their own. In fact, the organ grew as the patients grew,” Atala tells U.S. News. “We followed this very closely: did yearly X-rays, visualized them yearly with endoscopy, did biopsies, did sexual function questionnaires yearly, and they were still in the normal range eight years later.”?
The procedure is still a long way from becoming common practice, and Atala’s team declined to estimate its cost.
“Even if we were able to add up the cost of materials and researchers’ time, the costs to treat these first four patients wouldn’t correspond to what the treatment would cost if it is one day commercially available,” they say in an emailed statement to U.S. News.
For the four women, though, and the doctors who performed the procedure, “It was very rewarding,” Atala says. “With these conditions that they had, it’s not just the anatomical defect, it’s also the overall emotional well-being for them – for any patient – who has this type of challenge.”
The new procedure he and his team used could offer some advantages over current treatments for MRHK, which call for dilating existing tissue or using reconstructive surgery to create completely new vaginal tissue, at times by using skin grafts of tissue that lines the abdominal cavity.
This method can be rife with problems: The so-called vaginal “substitutes” frequently lack a muscle layer, which can lead to a contracting or narrowing of the vagina. As many as 75 percent of pediatric patients suffer complications from the procedure, most often due to narrowing or contracting.
The new procedure has been in the works since the early 1990s, when Atala and his team first explored lab-built vaginas in rabbits and mice.
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