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Intro：
John Brotherton (Ph.D, Vice-President of Technology)
Dr. Brotherton received his PH.D. in chemical engineering from the university of California, San Diego.
His expertise covers the design of hollow fiber bioreactors for support of mammalian cell growth. Dr. Brotherton held a position as an engineer at the space systems division of General Dynamics, and spent 7 years at Vitagen in the design, development and testing of the ELAD system, including the bedside unit.
The ELAD system is a bio-artificial liver therapy that provides liver support to patients utilizing Vital Therapies’ proprietary C3A human hepatocyte cell line. The ELAD system consists of an extracorporeal circuit that draw blood from the patient via a dual lumen catheter placed in a large vein using a blood pump. Plasma fluid (ultrafiltrate) is separated from cellular components of the blood using an ultrafiltrate generator, a dialysis-type hollow fiber cartridge of specific permeability. The ultrfiltrate is pumped to a recirculation circuit which includes four ELAD cartridges. The ultrafiltrate flows through all of the ELAD cartridges, each of which contains approximately 110 grams of C3A cells. The recirculation circuit is driven by a centrifugal pump, and also contains an oxygenator, a heat exchanger, and a cell filter. The purpose of the recirculation cartridge support circuit is to provide the proper environment (temperature, pressure, PH, and oxygen concentration )for the ELAD cell cartridges .the treated (recirculated ) ultrafiltrate passes through cell filter and is recombined with the cellular components of the patient’s blood. The recombined whole blood and ultrafiltrate is returned to patient through the dual lumen catheter.this circulation is maintained continuously for up to twelve days of therapy.
Intro：
Wang Bao’en (Beijing Friendship Hospital Liver Disease Special Outpatient Department)
Wang Bao’en is Honorary President of Beijing Friendship Hospital, Professor, Professor of Treatment, Doctoral Tutor, and concurrently Deputy Director of the Chinese Medical Association, Honorary Director of Chinese Liver Disease Association and Medicine Association; Deputy Member of Chinese Combining Association of TCM and Western Medicine and concurrently Director Member of Liver Disease Special Committee, Member of World Liver Disease Association and United Stated institute of digestive endoscopy, Executive Member of Asian Pacific Liver Disease Association, Member of the New York Academy of Science.
Quesition: What’s the role of Traditional Chinese Medicine in the process of anti-hepafibrosis?
Pro. Wang: The comprehensive basis study of hepafibrosis in Western Medicine is considered as a prerequisite base for the development of anti-hepafibrosis therapy, of which some forward therapies are still in experimental stage. Chinese medical staff working on the combining of TCM and Western Medicine, on the other hand, are able to take traditional medical advantages to put forward certain principles and medicament, which have been used in clinical treatment and proved fruitful, with medicanism study developed under way. It is obvious that anti-virus therapy on chronic hepatitis B is quite important while fibrosis therapy proves necessary, so the combining of both ways of treatment would turn out to be of much better medical effect.
Intro：
Chen Jumei, Professor of Treatment, Professor, Doctoral Tutor, Leader of Guding Team of PLA Hepatitis Prevention and Cure Technology, Leader of Expert Team of PLA No.302 Hospital, receiver of Special Allowance from Chinese Government, Director Member on the Editorial Board of Infectious Disease Information Magazine, Editor of PLA Preventive Medicine Magazine.
The ELAD bio-artificial liver cell performed well and the whole system ran smoothly during the treatment. ELAD bio-artificial liver can obviously promote the recovery of the patient’s physical condition, drastically reduce bilirubin and enhance survival rate in the treatment group rather than the control group. ELAD bio-artificial liver treatment had some adverse events related to extracorporeal recirculation and continuous anti-coagulation. More attention should be paid to the blood coagulation state and the test results of ACT and APTT, which were used to guide the dose of anti-coagulant. In general the safety of the system has been proven.
Question: How to diagnose liver failure in early stage?
Pro. Chen: According to the detailed introduction on how to diagnose liver failure at early stage in our Diagnosis Guide Book, the major symptoms of such disease are extreme fatigue and obviously negative symptoms of the alimentary canal, which are not included in western medicine. Here we advice patients who may possibly develop liver failure that they should go to see the doctor as soon as any uncomfortable symptom is noticed. The patient infected with hepatitis B himself is advised to take good care of his health, without any thought of taking things easy and feeling all right with himself until it’s too late. Negligence of such disease would lead to sever hepatitis or even hepatocirrhosis. We have received many patients like this who usually don’t care much about their symptom and consider themselves all right with these hepatic virus that is otherwise very dangerous and harmful to everyone.
Intro：
Duan Zhongping (Professor of Treatment, Professor, Doctoral Tutor, presently Vice President of Beijing You’an Hospital affiliated to Capital Medicine University)
The development and application of artificial liver technology presents new challenges and requirements to the nurse work. First of all, the cross-discipline characteristic of this technology puts forward new requirements, which would not necessarily be met by basic nurse work in traditional practices. Nurses for artificial liver are expected not only to handle basic and common nurse work, but also have multidisciplinary knowledge of device management and usage, macromolecule materials, tissue cell culture methods, and emergency aids, etc. They also have to learn application know-how and relevant literature of a great number of imported equipments. Above all, those nurses are required to have solid foundation of a foreign language.
At the same time, the development of artificial liver technology also brings opportunity and power to the nurse work. Human organ support technology is one of the major goals of 21st Century Medical Discpline Development. As a late-starter on technology but a fast-developer, both the therapy and the nurse work of artificial liver technology are now at synchro-developing stage, so all the nurses involved should have good command of traditional nurse theory and technique, and keep on learning new knowledge as well for the goal of “keeping up with the time”. Only in this way would they be qualified for the required nurse work, and provide high quality service to patients and further make contribution to the advancement and development of the nurse work. Pro. Duan also added that, “Liver disease is a major medical problem in China, and there’s an overwhelming and unmet need for new therapies. I see many patients in our hospital every month whose lives are threatened by liver disease. We desperately need a new option that will provide metabolic function and allow time for patients’ livers to recover or regenerate”
Intro：
Dr. Millis is Professor of Surgery of the Operation and Transplantation Department at University of Chicago. Dr. Millis has been associated with Vital Therapies’ ELAD (extracorporeal liver-assist device) since 1994. He became the chairman of the Vital Therapies Clinical Advisory Board (“CAB”) and the CAB working group in 2003 and Chair of the China Clinical Advisory Board (“CAB”) in 2004. Dr. Millis had been invited to become a member of VTI board of directors in early 2007. During the Phase I study, he was the principal investigator at the first site (University of Chicago). He enrolled five patients in the ELAD group.
According to Dr.Millis in CBS news, clinical trials are well under way using ELAD system in Chicago. AIMLI, a 20-year-old girl, was a lucky patient who survived from sever liver disease by such a bio-artificial liver. At those critical days, ELAD system was the only choice for AIMILI to be saved from serious disease. In ELAD system, the reactor is full of active human hepatocytes. While waiting for an available donor liver for a liver transplantation, the patient was connected to ELAD, which transferred his blood through vascular systems to the bioreactor while metabolizing toxins plus synthesizing proteins and other liver specific products essential for life. AIMILI was supported by ELAD machine for up to four days until an donor liver became available for her, and then she received a 6-hour successful liver transplantation. From this, it is obvious that ELAD system augments the metabolic functions of a human liver and frees the patient’s liver to recover, thereby enabling a bridge to a transplant or liver recovery.
In the above case, the liver disease is mainly caused by viral infection resulted from a cold, and virus somehow rush into the patient’s liver before a fulminant hepatic failure occurred. The sudden failure would often be worsened in days and soon lead to death, resulting in about 2,000 deaths every year in the U.S. ELAD system with its effective functions, however, presents a great milestone in medical development of sever liver disease therapy.
Intro：
Dr He is an M.D. from Shanghai First Medical University, P.R. China, where he did clinical research in liver pathology. His postdoctoral fellowship work at University of California Davis involved cancer therapy, and at Baylor College of Medicine Department of Pathology he studied liver disease and developing clones from human primary hepatocytes. Dr. He joined Hepatix in 1990 and has been involved in research and development of ELAD? for 7 years, and the manufacturing of ELAD? for 6 years through all clinical testing. He is an expert in nurturing and growing the cell line and preparing the ELAD? cartridges.
So far, there is no contrasted clinical study available all over the world on liver failure therapy device with liver cells, and most treatment products in this aspect are still in pre-clinical stage. Vital Therapies, Inc., however, as an excellent leader of liver disease therapy development, has received several relevant advantages with great efforts, which included the rare protection approved by FDA of the U.S. for disease drugs. At present, available detoxifying device includes albumin-dialysis, active carbon for drug use, or ion exchange resin filtration plasmapheresis, all of which are not identified as standard treatment procedures, yet to be proved exact medical effect before any clinical trials. By now, clinical trials made by Vital Therapies, Inc. in China has come to an end, with successful treatments of several sever hepatitis B patients by ELAD system.
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