Life-saver for HK liver patients
Hong Kong's hospitals could be the first in the world to use a system able to save the lives of patients with liver failure by cleaning their blood with pigs' liver cells without the need for a transplant.
The US-based inventor of the out-of-body, bio-artificial device will move to the city and join local universities and hospitals to offer the treatment to patients in Asia.
After more than a decade of development work, it is now ready for the final phase of clinical trials and is expected to be on the market in 18 months, Dr Daniel Miller said.
Miller, chief executive of system developer Excorp Medical, expects the treatment to cost HK$200,000 to HK$500,000 for a patient, a tenth of the cost of a liver transplant.
The system is designed to remove potentially fatal toxins from the blood while giving the liver time to repair itself.
'The bio-artificial liver will stabilise a patient by protecting the heart, lung, brain and kidneys from the effects of the toxins circulating in the blood that the dysfunctional liver is not able to handle adequately,' Miller said.
Five patients in the US have used the system in clinical trials with the University of Pittsburgh since 2000. One was a patient who had the autoimmune disease systemic lupus erythematosus, who had suffered acute liver failure due to an overdose of painkillers.
She awoke from a coma after two 12-hour treatment sessions in three days and could sit up and talk to family on the fourth day.
'The bio-artificial liver system postponed the need for a transplant,' Miller said, adding that it was not certain whether such patients would need transplants later in life.
The other four patients reacted similarly to the treatment.
Work on the project started in 1996. The first two phases of clinical trials, which began in 2000, confirmed that severely ill patients could be treated with the system without destabilising their condition or interfering with the other treatments, Miller said.
Excorp is about to start the final clinical trial to prove statistically that the system can benefit the patient safely and consistently and that the manufacturer can provide the product to the hospitals in a reliable manner. It hopes to work with the University of Hong Kong's Clinical Trials Centre on the clinical programme, but the university says plans are yet to be confirmed.
The biomedical company hopes to move its headquarters and set up a research and manufacturing facility of around 7,500 sq ft at the Hong Kong Science and Technology Park this year. The park has accepted its application for a site.
Excorp has also reached an agreement with Chinese University for its Laboratory Animal Services Centre to supply the specially bred pigs from which liver cells for the system will be harvested.
The centre's director. Dr Antony James, said: 'Their research papers show that they have got good science on the clinical side. The university was satisfied with the ethics behind it and their study design is strong.'
Since 2005, Excorp has been looking for partners in China, as the major group of patients will be Asians.
Miller plans to launch the product first in Hong Kong, then in mainland China and India.
It already has an investor from Hong Kong - Mike Rowse, the former director general of InvestHK who recently became director of the company's Hong Kong subsidiary.
Miller believes US biomedical companies relocating to Asia will become a trend.
'The appetite for cutting-edge technology in Asia is bigger than in local US. But many don't have a clear idea on how to go about bringing the technology to Asia.'
The number of patients in Hong Kong who died waiting for a liver transplant last year - up from 18 in 2010 - according to the Hospital Authority