News Release Lancet Article
for Release until 6:30
p.m. ET, Thursday, April 10
Vaginas Implanted in Patients, Scientists Report
– April 10, 2014
– Scientists reported today the first human recipients of laboratory-grown
vaginal organs. A research team led by Anthony Atala, M.D., director of Wake
Forest Baptist Medical Center’s Institute for Regenerative Medicine, describes
in the Lancet long-term success in four teenage girls who received vaginal
organs that were engineered with their own cells.
“This pilot study is the first to demonstrate that vaginal organs can be
constructed in the lab and used successfully in humans,” said Atala. “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 girls in the study were born with Mayer-Rokitansky-Küster-Hauser (MRKH)
syndrome, a rare genetic condition in which the vagina and uterus are
underdeveloped or absent. The treatment could also potentially be applied to
patients with vaginal cancer or injuries, according to the researchers.
The girls were between 13 and 18 years old at the time of the surgeries, which
were performed between June 2005 and October 2008. Data from annual follow-up
visits show that even up to eight years after the surgeries, the organs had
“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 Metropolitan Autonomous University in
Mexico City, where the surgeries were performed.
In addition, the patients’ responses to a Female Sexual Function Index
questionnaire showed they had normal sexual function after the treatment,
including desire and pain-free intercourse.
The organ structures were engineered using muscle and epithelial cells (the
cells that line the body’s cavities) from a small biopsy of each patient’s
external genitals. In a Good Manufacturing Practices facility, the cells were
extracted from the tissues, expanded and then placed on a biodegradable
material that was hand-sewn into a vagina-like shape. These scaffolds were
tailor-made to fit each patient.
About five to six weeks after the biopsy, surgeons created a canal in the patient’s
pelvis and sutured the scaffold to reproductive structures. Previous laboratory
and clinical research in Atala’s lab has shown that once cell-seeded scaffolds
are implanted in the body, nerves and blood vessels form and the cells expand
and form tissue. At the same time the scaffolding material is being absorbed by
the body, the cells lay down materials to form a permanent support structure –
gradually replacing the engineered scaffold with a new organ.
Followup testing on the lab-engineered vaginas showed the margin between native
tissue and the engineered segments was indistinguishable and that the scaffold
had developed into tri-layer vaginal tissue.
Current treatments for MRHK syndrome include dilation of existing tissue or
reconstructive surgery to create new vaginal tissue. A variety of materials can
be used to surgically construct a new vagina – from skin grafts to tissue that
lines the abdominal cavity. However, these substitutes often lack a normal
muscle layer and some patients can develop a narrowing or contracting of the
The researchers say that with conventional treatments, the overall complication
rate is as high as 75 percent in pediatric patients, with the need for vaginal
dilation due to narrowing being the most common complication.
Before beginning the pilot clinical study, Atala’s team evaluated lab-built
vaginas in mice and rabbits beginning in the early 1990s. In these studies,
scientists discovered the importance of using cells on the scaffolds. Atala’s
team used a similar approach to engineer replacement bladders that were
implanted in nine children beginning in 1998, becoming the first in the world
to implant laboratory-grown organs in humans. The team has also successfully
implanted lab-engineered urine tubes (urethras) into young boys.
The team said the current study is limited because of its size, and that it
will be important to gain further clinical experience with the technique and to
compare it with established surgical procedures.
Co-researchers were James J. Yoo, M.D., Ph.D., and Shay Soker, Ph.D., Wake
Forest Baptist, and Diego R. Esquiliano M.D., Reyna Fierro-Pastrana P.hD.,
Esther Lopez-Bayghen Ph.D., Pedro Valencia M.D., and Ricardo Ordorica-Flores,
M.D.,Children’s Hospital Mexico Federico Gomez Metropolitan Autonomous
Contacts: Karen Richardson, mailto:email@example.com, 336-716-4453, main number 336-716-4587.
Note to Editors: To download embargoed
high-resolution video and still images related to this research, visit: http://www.wakehealth.edu/aboutus/aboutusl1.aspx?id=84381
Anthony Atala, M.D., is available for interviews
beginning at 8:30 a.m. ET on Wednesday, April 9. In addition, from 4:30-5 p.m.
ET, he is available to answer questions via an audio news conference. Call-in
numbers: 800 381 7839 (North America);
08004961447 (United Kingdom); 0018005146650 (Mexico).
About the Wake Forest Institute for Regenerative Medicine
Wake Forest Institute for Regenerative Medicine (www.wfirm.org) is dedicated to the discovery, development and clinical
translation of regenerative medicine technologies. The institute has used
biomaterials alone, cell therapies, and engineered tissues and organs for the
treatment of patients with injury or disease. Institute scientists were the
first in the world to engineer a replacement organ in the laboratory that was
successfully implanted in patients. The Institute is based at Wake Forest Baptist Medical Center (www.wakehealth.edu), a fully integrated academic medical center located in Winston-Salem, North
Carolina. The institution comprises the medical education and research
components of Wake Forest School of Medicine, the integrated clinical structure
and consumer brand Wake Forest Baptist Health, which includes North Carolina
Baptist Hospital and Brenner Children’s Hospital, the commercialization of
research discoveries through the Piedmont Triad Research Park, as well a
network of affiliated community based hospitals, physician practices,
outpatient services and other medical facilities.