Laboratory-Grown Vaginas Implanted in Patients, Scientists Report


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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

IN: BIM HEA MTC

SU: TRI SVY

PRN

-- DC03689 --

0000 04/11/2014 16:29:00 EDT http://www.prnewswire.com

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