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Injectable polymer stimulates the regeneration of new cartilage by forming "adhesive scaffolding" onto which the body's own cartilage rebuilds, which could avoid the need for total knee replacement surgery.

One in five Canadians will be diagnosed with arthritis in the next 20 years, adding to the more than 4 million who currently deal with the chronic disease.

Included in that 20% figure are those people with joint disorders – especially worn-out knees and hips – from damaged cartilage. Such disorders are second only to cardiovascular disease for the financial strain they put on the health care system.

Often, the only way to restore mobility and relieve pain is through joint replacement surgery. According to a 2004 Medical Post report, the number of total hip and knee replacements in Canada rose by almost 40% in seven years, with doctors performing more than 45,000 such operations annually.

Meanwhile, wait times have become daunting: In Ontario in 2005, patients waited an average of 33 weeks for knee replacement surgery and 24 weeks for hip replacements.

The surgery is costly, painful and often temporary. Many replacement joints have a lifespan of between one and two decades, after which they must be replaced.

It was this health care challenge that drove Dr. Michael Buschmann, of the Département de génie chimique at École Polytechnique de Montréal, to look for solutions.

Eight years ago, he joined a team of social and natural scientists to develop a treatment for damaged cartilage that might postpone the need for joint replacement surgery. Now, after an intensive research and development program and with support from the Canadian Arthritis Network (CAN), he estimates the technology he and a group of scientists and engineers have created – a gel that is injected into damaged knees to help them to rebuild new cartilage – is just two years away from going to market.

"With the high prevalence of arthritis in our society, and because the human body does not have the ability to repair or replace cartilage, this issue needed to be quickly addressed," says Dr. Buschmann. "In our early trials, patients have seen clinical benefit."

He stresses that these were humanitarian trials approved through Health Canada's Special Access Program, rather than official clinical trials. They involved 33 patients with varying degrees of joint degeneration. The researchers were encouraged by the results, and look forward to the upcoming pivotal third phase clinical trials.

The technology they've created is a polymer (a chain of repeating molecules) with a composition they call BST-CarGel^®. It can stimulate the regeneration of new cartilage by forming "adhesive scaffolding" onto which the body's own cartilage builds, allowing bones in joints to glide smoothly over each other.

The intellectual property rights for BST-CarGel^® have been transferred to BioSyntech, a Montreal-based company specializing in injectable biomaterials for tissue repair and therapeutic delivery. BioSyntech plans to commercialize this discovery and has received Health Canada approval to proceed with clinical trials.

“We believe that BST-CarGel^® is a potential solution to this growing need to repair cartilage damage and, to that end, have initiated a controlled and randomized clinical trial with a strong scientific design," said Mr. Claude LeDuc, President and CEO of BioSyntech. "Our trial data will not only support Canadian and European approval, but may be instrumental in gaining regulatory approval in the United States.”

Dr. Buschmann, who leads a 19-person team of researchers at École Polytechnique, says the development of the BST-CarGel^® was greatly enhanced with help from the NCE program and would have been difficult to achieve without CAN.

In the BST-CarGel^® program, Dr. Buschmann worked with physicists, chemists, biologists, an orthopedic veterinary surgeon, cartilage experts and bone biologists. He has also made useful connections with social scientists who provide perspective on methodology, outcome analysis, proper design of clinical scoring systems and information about reimbursement issues for patients.

"Being involved in CAN has given me the funding to explore new ideas, plus I have the ability to collaborate with people outside the range of science that I most often work with," says Dr. Buschmann.

www.arthritisnetwork.ca