Human tissues recycled into medical products for operations

Gerard Ryle

July 3, 2006

TO GET to the human tissue processing plant, you turn down a suburban Sydney street and pass a bottle shop until you reach glass doors fronting an otherwise unremarkable business park.

Inside, everything is one-way. Those allowed to cross the colour-coded, sterile spaces of the inner sanctum are cloaked from head to toe in blue surgical overalls. There is a door to enter, another to exit; and a series of pressurised chambers ensure that the air always blows outwards.

Here, in white antiseptic "clean rooms", human bones and tendons will soon be stripped and dipped in acid, and the specialist tools come in many different forms and sizes.

"We had this one shipped in from the United States," says Sharon Bryce, the plant's director of tissue services, pointing to what looks like a large cappuccino machine.

"This is an automated grinder. You can dial up the size of the granule of bone that you want."

Several kinds of metal scrapers are lined up on a trolley like silver soldiers. "They are purely and simply to strip the tissue off the bone," she says. "They have got very sharp edges, and they come in four different shapes."

"There is one like a diamond, and there is one like a teardrop."

When it reaches full capacity, Australian Biotechnologies hopes to be processing parts from up to 1200 cadavers a year through its Frenchs Forest plant.

Many of the products will be offered to Australians for the first time. The uses of the crushed bone will include filling voids caused by cancer; or special surgical glue; or pins and screws and blocks for spinal operations.

The ligaments will be stripped and cleaned and be ready for reuse by injured athletes, or by people needing knee reconstruction, or reconstruction after cancer surgery or trauma.

"We are very keen for everyone to know what is happening here, to know how badly and desperately needed tissue grafts are," says Terrell Suddarth, the company's chief operations officer.

"Surgeons have been wanting it [the products] for 10 years," Mr Suddarth says. "And we can't give it to them because it is not available in Australia."

Only brain-dead patients can be considered as organ donors, and there are usually only about 50 of those a year in NSW. In tissue recycling a wider range of donations can be used than those suitable for organ transplantation.

Australian Biotechnologies will be able to accept tissue from suicide and heart attack victims, and just about anyone else who dies, after they have been screened for viruses.

"There's the downside to what we do, where the tissue has to come from," Mr Suddarth says. "But this gives a little bit of good out of the bad situation that has happened, to be able to donate this tissue and know that you are going to go on and help 50 or 60 other people."

The company is a partnership between the South-Eastern Sydney and Illawarra Area Health Service, two former medical device executives and some Sydney surgeons. The health service's job is to locate the bodies, through the State Coroner's office in Glebe and, eventually from Westmead, Newcastle and Wollongong.

With the permission of relatives, the body parts will be collected by technicians who have been trained by the private company but who work for the NSW Bone Bank. The tissue will then be sent in polystyrene foam coolers, via courier, to Frenchs Forest. Australian Bio-technologies will transform the raw material into products such as demineralised bone matrix, a mix of human bone and other substances that kick-starts new bone growth in patients who have had bone removed.

It is illegal to profit from the trade of human tissue. But Australian Biotechnologies does not shy away from its for-profit nature. By charging for the processes it applies to the tissue, rather than the actual tissue, the company can bypass the laws that curtail trade. It can also profit from non-human material added to make the medical products.

"They [the NSW Government] could have done this themselves but, for one thing, they did not have the technology in order to be able to do it. There is a huge capital outlay in the beginning," says Mr Suddarth, who was hired from the world's fourth-largest human tissue processor, a US non-profit entity, AlloSource.

"It is a medical company we pretty much have built from the ground up. From a government standpoint, no one will put up that kind of money."

In NSW, using tissues from cadavers is not new. Entities such as the Queensland Bone Bank - a Queensland Government body - have supplied frozen tissue to NSW hospitals for more than 10 years. Australian Biotechnologies differs in the range and quality of the products it will offer, Mr Suddarth says, once the company gets its clearance papers from the Therapeutic Goods Administration. Those papers are expected in the next two months.

"It takes the private entity to be able to bring those products out to market," he says. "It is the population of NSW that is going to benefit from this."

By keeping the collection arm of the enterprise under the NSW Government, the company hopes to avoid the problems that have dogged the $US1 billion tissue processing industry in the US.

The issues were starkly illustrated in a recent scandal in which some medical products implanted into patients in the US were made from body parts that had been stolen from New York funeral homes.

Copyright © 2006 The Sydney Morning Herald.

This article posted August 17, 2006.