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-- WITH PHOTO -- TO HEALTH, MEDICAL, AND NATIONAL EDITORS:
Laboratory-Grown Vaginas Implanted in Patients, Scientists Report
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=84381Live Video Conference: You are invited to a Newswise Live event on Friday April 11th at 12:30-1:00 PM EST featuring Dr. Anthony Atala answering your questions about this research.The Newswise Live welcome room for the event will open at 11:30 AM EDT. You are invited to drop in, get comfortable, address any technical issues you might encounter, then go about your work until the event begins at 12:30. If this is your first time participating in a Newswise Live event, we urge you join the welcome room early.From your computer browser click: https://newswiselive.zoom.us/j/7459578068 and follow the simple directions. If you are using an iPhone or iPad, you will need to download an application by clicking https://itunes.apple.com/us/app/id546505307
WINSTON-SALEM, N.C., April 11, 2014 /PRNewswire-USNewswire/ --
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 normal function.
"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,
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 vagina.
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 University, Mexico.
Logo - http://photos.prnewswire.com/prnh/20111114/DC06171LOGO
SOURCE Wake Forest Baptist Medical Center
-0- 04/11/2014
/CONTACT: Karen Richardson, krchrdsn@wfubmc.edu, 336-716-4453, main number 336-716-4587
/Photo: http://photos.prnewswire.com/prnh/20111114/DC06171LOGO
CO: Wake Forest Baptist Medical Center
ST: North Carolina
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SU: TRI SVY
PRN
-- DC03689 --
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