Canada is the first country in the world to approve the sale of a manufactured human skin.
Using cells from infant foreskin, a company in Canton, Mass., called Organogenesis makes what it calls a human skin equivalent. And when the hockey-puck-sized skin samples are completed they are sent to Canada, which last April became the first country in the world to approve the product for commercial use.
"In our experience, Canada has never been first at launching anything," said Geoff Mackay, the product manager of Novartis Pharmaceuticals' biotechnology unit. Novartis is licensed to market the skin product in Canada.
"Now Canadian scientists and physicians are leading the world in refining it, doing the clinical studies to answer the question of how it can be used."
Since last April, when Apligraf was first given the go ahead for commercial use, it has been used on only about 200 people, but the potential demand for the skin product and others like it are huge.
According to Organogenesis, in Canada alone there are about 150,000 people with open wounds, such as venous ulcers and burns, who could benefit from Apligraf. Supply shouldn't be a problem, because a single foreskin can produce 200,000 skin samples.
If the science seems astounding, the technique is simple. Samples of foreskin are brought to the Organogenesis labs from a Boston hospital, where they are broken down into their cellular components and put in cell banks where "they grow and grow and grow."
Those cells are then seeded into a petri dish filled with bovine collagen.
"They arrange themselves like a human dermis," Mackay said.
About three weeks later, a complete piece of human-equivalent skin is teased out of the petri dish.
"The big breakthrough is now you have a living organ the skin that can be taken from one person, put on another, and there's no rejection, no need for imuno-suppression."
Apligraf is just the beginning of what researchers are calling a medical revolution: the field of tissue engineering. And more and more complex examples of tissue engineering should be ready for human use soon.
Research companies say manufactured products such as cartilage, blood vessels, bone, ears and corneas are within striking distance. Hearts, livers and more complex organs could be as little as 10 or 15 years down the road.
"These are spare parts for the human body," said Dr. Francois Auger, a researcher at the University of Laval in Quebec City.
"This is a huge field," said Dr. William Freeland, chief of the medical device evaluation division of Health Canada.
"A lot of interesting developments are getting ready to come to market."
And the first market they seem to head for is Canada. Since Apligraf was certified for commercial use, two more manufactured skin products have made their commercial debut: Dermagraft, ana variant Dermagraft-TC made by Advanced Tissue Sciences of La Jolla, Calif., and marketed in Canada by Smith and Nephew.
Written by Tod Mohamed, Ottawa Citizen,©1998 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed
© 1998 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.