Study Describes Successful Introduction of Lab-Made Vaginas in Four Women

A new study reported that four women who were implanted with lab-made vaginas eight years back are leading normal sexual lives.

The research shows that vaginas engineered from patients' own cells could be implanted in women born with underdeveloped or absent vagina and also in women with cancers or injuries.

The organs were made by researchers at Wake Forest Baptist Medical Center's Institute for Regenerative Medicine and colleagues.  Follow-up studies show that the engineered cells in these four women are indistinguishable from normal cells.

"This pilot study is the first to demonstrate that vaginal organs can be constructed in the lab and used successfully in humans," said Anthony Atala, M.D., director of Wake Forest Baptist Medical Center's Institute for Regenerative Medicine. "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."

The women in the study were suffering from Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome, which is a rare disorder characterized by underdeveloped or absent vagina and uterus. The condition affects one in 4500 women. According to the researchers, the latest lab-grown vaginas could even be used in women suffering from cancers and vaginal injuries.

To make the vaginas, researchers took muscles and epithelial cells from biopsies obtained from the patients' genitals. These cells were grown in a lab and placed on a biodegradable scaffold that resembled a vagina. The scaffolds were customized for each patient.

The surgical team then created a canal in patients' pelvis and stitched the cell-containing scaffold to the reproductive structures. Previous research has shown that once the cells are in the body, the nerves and blood vessels in the region start making connections and form a tissue. The biodegradable material is absorbed by the body and the patient is left with an engineered vagina.

The patients in the study were between 13 and 18 years old at the time of the surgeries. Researchers transplanted the vaginas in the patients between June 2005 and October 2008. The team found that even eight years after the surgery, the vaginas perform as expected.

"Tissue biopsies, MRI scans and internal exams using magnification all showed that the engineered vaginas were similar in makeup and function to native tissue," said Atlantida-Raya Rivera, lead author and director of the HIMFG Tissue Engineering Laboratory at the MRKH in Mexico City, according to a news release.

Patients' quality of life was also restored to some extent. Women in the study reported having desire and pain-free intercourse post-surgery. Their sexual function was assessed using Female Sexual Function Index questionnaire.

Current treatments for MRKH include expansion of existing vaginal cells or reconstructive surgery. However, the complication rate is high; as much as 75 percent. And, patients lack muscle control in the vagina.

Atala and his team have been working towards creating a lab-grown vagina since the 1990s. The team has tested the organs in mice and rabbits. Atala and colleagues have created lab-made bladders and urethra and transplanted then in human patients.

The study is published in the journal The Lancet.