Gannet Newspapers 8/28/97
Teen to have fragile skin replaced at Med Center
by Cheryl Alkon
Gaston Calligaris has
lived his sixteen years
wrapped in bandages.
He sleeps with his eyes open because his eyelids have all but disappeared.
The teen lives with a rare skin disorder called Epidermolysis Bullosa, or
EB. The top layer of his skin does not bond well with the underlying layers. It instead
peels off if he brushes against anything, or in the case of his eyes, when he blinks.
Calligaris, who hails from Buenos Aries, Argentina, is at the Westchester County Medical
Center in Valhalla for an experimental procedure today that will replace the damaged skin
on his eyelids and legs with a skin replacement manufactured by Ortec International in
Manhattan.
" Basically, you live a life wrapped in bandages and gauze," said Dr Jane Petro,
describing how children with EB cope with the condition." If you pick them up, their
skin will peel off."
InTouch
New York Medical College
Jan 1998
Experimental surgical treatment offers
new hope to victims of skin disorders
A specialized team of surgeons
led by Jane A. Petro, M.D., associate professor of surgery at NYMC and associate director
of the Plastic Surgery and Rehabilitation Burn Center at Westchester Medical Center (WMC),
is hoping to improve the prognosis for burn victims and children with a rare and
debilitating disease called epidermolysis Bullosa (EB) using healthy skin created in the
laboratory.
Ortec International Inc., a New York based company has developed a product that it calls
composite cultured skin (CCS), which is grown from skin cells taken from newly circumcised
infants' foreskins in combination with a collagen sponge layer taken from cows. Unlike
traditional skin grafting, whereby healthy cells must be harvested from donor sites on a
patient already burned or scarred over much of the body, and which the body will sometimes
reject, CCS can be developed in large sheets. early studies show no signs of rejection by
recipients. In addition, CCS heals quickly, with little or no infection or inflammation.
It can be applied without sutures or staples and it results in less scarring than
traditional skin grafting procedures.
This promising treatment is of special interest to the families of patients of EB, a
genetic disorder that causes the skin and mucous membranes to blister and peel away from
the body at the slightest touch, leaving a raw surface prone to infection and scarring.
Some cases can become severe enough to lead to disfigurement and immobility in digits and
limbs. According to the Dystrophic Epidermolysis Bullosa Research Assoc., Inc, more than
50,000 Americans, primarily children, suffer from the disease and the mortality rate is
high.
One of Dr Petro's patients is Gaston Calligaris, a 17 year old from Argentina, whose
physician heard Dr Petro speak at a medical conference in Brazil last summer and brought
the boy's case to her attention.
Although procedures using CCS, which is still in clinical trials pending approval by the
Food and Drug Administration (FDA) , are not generally practiced at WMC, Dr Petro was
granted permission for " compassionate use" of the material in Gaston's case. |
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Petro, associate director of the hospital's burn unit,will perform today's procedure using
cultured composite skin manufactured by Ortec. the skin is created from discarded
foreskins of circumcised infants.It replaces the body's damaged skin and stimulates the
body to heal.
Petro has used the substance experimentally on burn victims, but never before on a patient
with EB. To use the skin from Ortec, Petro petitioned the Food and Drug Administration for
permission: the skin is being tested in clinical trials and has not yet been approved by
the FDA for unlimited use.
In the United States, there are 3,000 children who have EB; the worldwide figures are
unknown.The condition varies in severity. It can be fatal if it affects the inside of the
body, like the esophagus and the stomach lining.

Gaston Calligaris and Dr Jane Petro
In September the youth spent three weeks at the medical center undergoing surgery which
employed traditional skin grafting methods and CCS as a biological dressing to treat the
donor site wounds.
Dr Petro has performed reconstructive surgery on several young EB patients whose fingers
and hands had fused and contracted from scarring caused by the disease. Her task was to
separate the fingers and regraft the treated areas. During the procedure on Gaston, Dr
Petro found that not only did the grafts take well, but also" the skin we replaced
and repaired with CCS showed no sign of the disease,"even after some time had passed.
" because the areas of replaced skin appear to remain disease- free, we can do more
aggressive prevention, resulting in less severe deformities," she said. "It
could mean a possible cure for children with EB."
According to Jacqueline Norris ,R.N., clinical coordinator at the burn unit, Ortec is
nearing the end of Phase II clinical trials of CCS , which, if successful,will make the
product available for widespread use . There are 5 million people in the U.S. with chronic
wounds who can be helped by this technology," she said.
At the annual meeting of the American Burn Association in March, Dr Petro will present an
abstract poster session on the procedure she performed on Gaston Calligaris.
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