Hello sogoam-ga,
I had no idea that there is so much activity in liver transplant
research that focuses on device development. I’ve collected a variety
of resources to help answer your question. My research includes
general information about success factors for liver transplantation,
current trends in development of liver transplantation related medical
devices and finally, website and related references to liver
transplant device manufacturers.
Even from this limited amount of research it is clear that there is a
lot of activity in this industry and that new technologies are being
developed to help ensure improving success rates to liver
transplantation.
Best wishes for your research project.
~ czh ~
=====================================
SUCCESS FACTORS FOR LIVER TRANSPLANTS
=====================================
http://health.surfwax.com/files/Liver_Transplantation.html
News & Articles on Liver Transplantation
***** Keep up to date with current reports on liver transplants.
-------------------------------------------------
http://www.nlm.nih.gov/medlineplus/livertransplantation.html
Liver Transplantation
***** This is a very extensive collection of links covering every
aspect of liver transplantation. Browse the articles and other
resources to find answers to your questions about factors that will
help insure a successful liver transplant.
-------------------------------------------------
http://digestive.niddk.nih.gov/ddiseases/pubs/livertransplant_ez/index.htm#7
How is rejection prevented?
To keep your body from rejecting the new liver, you will take
medicines. These drugs, such as steroids, cyclosporine, tacrolimus,
sirolimus, and mycophenolate mofetil, are called immunosuppressants.
Immunosuppressants weaken your immune system's ability to reject your
new liver.
What are the other problems that can damage the liver transplant?
Return of the problem that made the transplant necessary in the first
place is the most common problem for patients with liver transplants.
Also, hepatitis C virus may damage a transplant if the patient was
infected before the operation took place.
Other problems include
-- blockage of the blood vessels going into or out of the liver
-- damage to the tubes that carry bile into the intestine
-------------------------------------------------
http://www.etenet.com/Apps/Library/Corporate.asp?ID=573
Liver Transplant
***** This site offers information and advice from a hospital that
covers what to expect if you are a candidate for a liver transplant.
-------------------------------------------------
http://www.vard.org/tts/avail/00-070.htm
Technology Transfer Program
VA TECHNOLOGY OPPORTUNITY BRIEF
Method for Identifying Preferred Liver-Transplant Donors
BACKGROUND:
As the demand for donor organs continues to grow faster than the
supply, it is critical to optimize survival results following
transplantation. Although several studies of transplant recipients
have identified specific factors associated with a poor outcome, it is
unknown to what extent genetic differences in donor organs contribute
to a poor outcome. Therefore, a genetic-based method is needed to
identify preferred transplant donors whose livers will increase the
likelihood of a successful outcome.
TECHNOLOGY OVERVIEW:
Following liver transplantation, a number of factors play a role in
determining the long-term success of the operation. One of the
greatest challenges to a patient's long-term survival is the
recurrence of underlying diseases. Hepatitis C-related liver failure
is the leading complication for liver transplant recipients, and the
majority of them will develop some evidence of recurrent hepatitis C
in their new livers.
The VA has identified a genetic-based method for determining
predictors of poor outcomes of liver transplantations. The agency
discovered that the genetic makeup of the donor liver, by virtue of
the nature and magnitude of its response to recurrent infection,
predicts the outcome of a transplant operation.
-------------------------------------------------
http://www.healthandage.com/Home/gid1=1485!gm=15
October 31, 2003
Combination therapy improves liver transplant outcome
A combination of two drugs effectively prevents recurrence of
hepatitis B infection after a liver transplant.
Infection with hepatitis B virus often leads to cirrhosis of the
liver, and liver cancer, leaving transplantation as the only treatment
option. Yet the high rate of recurrence of the viral infection means
that survival rates after transplant have been poor.
Now, however, there's a ray of hope for patients with hepatitis B.
Treatment with two drugs in combination - Hepatitis B Immune Globulin
(HBIg) and lamivudine greatly decreases the re-infection rate.
Researchers in Los Angeles studied a group of patients undergoing
liver transplant for hepatitis B infection. They found the one year
survival rate with combination therapy was 92 per cent, compared to 72
per cent with lamivudine alone and just 45 per cent with HBIg alone.
-------------------------------------------------
http://ca.fullcoverage.yahoo.com/fc/Canada/Organ_Transplants/
Yahoo! News -- Organ Transplants
***** Use this site to monitor the latest developments in organ
transplantation. Follow the links to resource sites to do further
research.
-------------------------------------------------
http://www.medscape.com/viewarticle/451209_2
Historical Perspective: The Early Era of Liver Transplantation
After careful study of the results of OLT, (orthotopic liver
transplantation ) it has become clear that survival is affected by
numerous preoperative, intraoperative, and postoperative factors.
Understanding the risk factors for poor outcome is therefore of
paramount importance. Preoperative factors such as age greater than 60
years, concomitant comorbid conditions (eg, cardiac and pulmonary
disease), degree of hepatic decompensation at the time of
transplantation, presence of renal failure, severe malnutrition, and
need for life support all influence survival.
-------------------------------------------------
http://www.fujisawa.com/medinfo/cont_educ/tran_trnd/tran_trnd_page.htm
Index of Current Transplant Trends Study Programs
***** You can review a selection of recent articles on transplant
trends.
-------------------------------------------------
Transplant Statistics: Annual Report : Organ Donation and
Transplantation Trends
CHAPTER I
Organ Donation and Transplantation Trends in the United States, 2001
This summary provides an overview of solid organ transplantation in
the United States produced as part of the 2002 OPTN/SRTR Annual
Report. This report is produced by the Scientific Registry of
Transplant Recipients (SRTR) in collaboration with the Organ
Procurement and Transplantation Network (OPTN) under contract with the
Health Resources and Services Administration (HRSA). This publication
addresses a range of activities related to solid organ transplantation
in the United States and is intended to be useful to patients, the
transplant community, the public, and the Federal Government.
***** This is a long report that gives you statistical insights into
trends in liver (and other organs) transplantation.
=====================================
MEDICAL DEVICES FOR LIVER TRANSPLANTS
=====================================
http://www.windhover.com/contents/monthly/exex/e_2002900062.htm
Liver Assist Devices: Proof of Life
(Start-Up: Windhover's Review of Emerging Medical Ventures, March 2002
page 19)
It was only 15 years ago that researchers discovered how to support
the essential type of liver cell, the hepatocyte, in culture. But
finally, after 20 years of research on liver assist devices, by
academic efforts, and recently, by a handful of commercial entities,
one first generation liver assist device is on the market and several
others are advancing into mid-stage clinical trials.
The potential rewards for being first in a brand new, multi-billion
dollar market, and of creating a therapy to help patients who would
otherwise die, has inspired more than a half a dozen companies to
develop extracorporeal liver assist devices designed to filter out
toxins, and in some systems, to also provide the synthetic and
metabolic functions of the liver. These companies, which have slowly
and steadily advanced into mid-, or even late-stage clinical trials,
include HemoTherapies Inc., Teraklin AG, Circe Biomedical Inc.,
VitaGen Inc., Excorp Medical Inc. and Algenix Inc. Dozens of venture
capital firms have placed bets in the new companies as well,
purchasing admission to a market that is potentially worth $3 billion.
The new liver assist device companies hope to prolong the lives of
patients so that they can receive transplants, help them recover and
avoid premature liver transplantation and a lifelong commitment to
immunosuppressant drugs.
As a starting point, the liver-support companies build upon the
extracorporeal blood circuitry and membrane filtering technology
created by the kidney dialysis and plasma pheresis (plasma separation)
industries. But with those components, the knowns about creating
products for liver failure end. The field of liver failure treatment
is in its infancy, and these companies all face scientific, clinical,
and marketing challenges as they create a brand new therapy.
-------------------------------------------------
http://www.bae.ncsu.edu/research/blanchard/www/465/textbook/otherprojects/2002/group_A/Liver/liver.html
Artificial Organs – Liver
The artificial liver can be used for several different reasons.
First, if the liver is severely damaged and over 80% of its tissue is
dead, the artificial liver device has the capabilities to support the
liver until it regenerates itself completely (Woo, 1998). If the
liver is able to regenerate itself without the need for a transplant,
the expensive cost of a liver transplant, which is around $200,000,
can be avoided (Klarreich, 2001). Second, the artificial liver device
allows for additional time for support for a patient waiting on the
list for a suitable organ. Third, an artificial liver can also be
used after a patient has received a liver transplant to help support
that patient until the new graft from the transplantation starts
generating new cells.
The first successful artificial liver devices developed were
filtered-based mechanical detoxifying systems. These systems use a
charcoal filter and a modified kidney dialysis machine to detoxify the
blood. The only Food and Drug Administration (FDA) approved
artificial liver device is a filter-based system called the Liver
Dialysis Unit™, which is made by HemoTherapies. Although this device
is FDA approved, FDA rules allow using this modified kidney dialysis
machine for the liver as long as it is safe, not for how effective it
is (Watanabe, 2001).
Types of Liver Devices
There are currently two types of liver devices, filtered-based
mechanical detoxifying systems and living cell-based bioartificial
systems that are being designed for temporary support of the liver.
Mechanical Systems
1. Liver Dialysis Unit™
2. Molecular Adsorbents Recirculating System (MARS)
Bioartificial Systems
1. Extracorpeal Liver Assist Device (ELAD)
-------------------------------------------------
http://www.cpmc.org/professionals/research/currents/2000LiverTX.html
Research Currents - 2000
New Techniques and Devices Are Revolutionizing Liver Transplantation
and Therapy
Liver assist devices, however, are only half a solution to a damaged
liver. They clear toxins but do not perform the liver's other vital
functions. Attention has turned to the creation of artificial liver
systems that, positioned outside the body like a liver-assist device,
would filter toxins as well as manufacture crucial biochemicals. Two
artificial liver machines are currently in human clinical trials.
A Different Strategy
Drs. Gish and Osorio, together with Dr. Sung-Soo Park of Ewha Womans
University (Seoul, Korea), have taken matters into their own hands.
They have established HepaHope, Inc., a company actively developing an
artificial liver device they hope will overcome the cell mass problem.
-------------------------------------------------
http://www.cbsnews.com/stories/2003/03/17/health/main544221.shtml
New Hope For Liver Transplant Patients
PITTSBURGH, March 17, 2003
An experimental artificial liver system that uses human cells to
filter blood plasma is undergoing trials in the hope that it will
serve as a successful bridge for patients awaiting a transplant
following sudden acute liver failure.
"Even given the best standard of care, there is no answer for a liver
that is dying and can't repair itself," he said.
The ELAD, which was developed by VitaGen Inc. of La Jolla, Calif., and
has not yet received approval from the U.S. Food and Drug
Administration, is one of a handful of devices researchers hope can
either be used to give patients' livers time to heal themselves or
keep people alive until a transplant can be performed.
One such device, developed by Excorp Medical Inc. of Oakdale, Minn.,
and also tested in Pittsburgh, uses pig liver cells to perform a
similar service, although Excorp president and CEO Dan Miller says the
intent with that system is to give patients' own livers time to heal.
============================
MEDICAL DEVICE MANUFACTURERS
============================
http://www.algenix.com/
Algenix, Inc.-- A Bioartificial Liver Company
Aware of the lack of treatment options for patients with diminishing
liver functions, Algenix, Inc. maintains a focus on liver disease
management. As such, we are committed to developing leading edge
technologies that provide temporary improvements in liver function.
Our long term goal of liver regeneration will allow patients to return
to a traditional quality of life.
Our lead product in development, the LIVERX 2000 SYSTEM, is an
external liver support system that incorporates porcine liver cells.
It is designed to treat acute and chronic liver failure by temporarily
providing essential liver function to those patients hospitalized with
liver failure.
-------------------------------------------------
http://www.teraklin.com/index-eng.html
TERAKLIN's focus is on artifical organ support. Thanks to our MARS®
therapy, we are the international market leader in the field of liver
support. MARS® offers professionals an opportunity to treat severe
liver failure, and gives patients a real life saving chance.
-----------------------------
http://www.endpointgroup.com/?page=Portfolio&item=HemoTherapies%20Inc.
HemoTherapies Inc. (founded in 1998 and located in San Diego,
California.)
Status: HemoTherapies is dedicated to being the global leader in liver
care. They market Liver Dialysis for the benefit of patients suffering
from liver disease and deliver support services for those who provide
and pay for their care.
Products: The Liver Dialysis Unit™ is the only liver-assist device
market-cleared by the FDA and available now for routine hospital use.
Liver Dialysis is used to treat patients with acute hepatic
encephalopathy (a relatively rapid change in brain activity and
consciousness that results from worsening liver disease) or severe
drug overdose.
http://medizin.li/profiles/company_he/he_00049796.htm
HemoTherapies Inc.
www.hemotherapies.com
(NOTE: The company’s website address seems to have been hijacked and
it is being redirected at this time.)
-------------------------------------------------
http://www.hepahope.com/
HepaHope, Inc., is a Los Angeles based start-up Bio-Technology Company
that was founded in February 1999, in Silicon Valley, California. The
mission of this company is to commercially develop, and bring to
clinical trial, a novel Bio-Artificial Liver (BAL) support technology
that was created by its founder and CEO, Sung-Soo Park, M.D., Ph.D.
This patent technology, HepaDialyzer™ (the company product) was
initially developed in Seoul, Korea and further developed at
California Pacific Medical Center at San Francisco. HepaHope, Inc. is
currently preparing FDA submission for Phase I/II Clinical Trial.
-------------------------------------------------
http://www.hepalife.com/
About HepaLife Technologies, Inc. (Symbol: HPLF)
HepaLife Technologies, Inc., publicly-traded under symbol HPLF (OTC
BB), is a development stage biotechnology company focused on the
research, development and eventual commercialization of technologies
and products to treat various forms of liver dysfunction and disease.
http://biz.yahoo.com/pz/030721/42873.html
July 21, 2003 -- HepaLife Technologies, Inc.: 25 Million Americans
Afflicted With Liver Disease
VANCOUVER, British Columbia, July 21, 2003 (PRIMEZONE) -- Presently,
through a Cooperative Research and Development Agreement (CRADA) with
the USDA's Agricultural Research Service, the primary tool linking
government and industry researchers, HepaLife Technologies, Inc. (OTC
BB:HPLF.OB - News) is collaborating towards optimizing the hepatic
functions of a patented cell line, whose hepatic characteristics have
been demonstrated to have potential application in the production of
an artificial liver device for use by human patients with liver
failure.
http://finance.yahoo.com/q?s=hplf.ob&d=t
HepaLife Technologies Inc (HPLF.OB)
-------------------------------------------------
http://www.exten.com/ex.asp
Exten Industries, through its subsidiaries, is dedicated to providing
solutions to the medical community for some of its most pressing
needs. These include better treatment options for chronic liver
disease, better research tools for the pharmaceutical industry,
complex plasma proteins for chronic and acute therapies, and stem
cells for cellular transplantation. We believe our patents and
proprietary technologies strongly position us for market success.
However, improving the quality of life of patients and participating
in their therapy ultimately drives us to succeed.
Exten Subsidiaries:
http://www.multicelltechnologies.com/
MultiCell Technologies, Inc. (MCT) is a wholly owned subsidiary of
Exten Industries, Inc. (OTC:EXTI.OB). MCT is a leading developer of
hepatic cells and cell lines that retain highly differentiated liver
function.
http://www.exten.com/exten2/sybiol.htm
http://www.exten.com/exten2/teamxenogenics.htm
Sybiol® Synthetic Bio-Liver Device Description
The Sybiol® synthetic bio-liver device now being developed by Exten
Industries' Xenogenics Corporation subsidiary is designed to treat
liver patients. It circulates patients' blood through a replaceable
cartridge interfaced with constantly recirculating living liver cells,
removing toxins from the blood and more. --- The innovative Sybiol
technology operates outside the body, similar to a kidney dialysis
treatment, using a highly efficient biological metabolic process.
-------------------------------------------------
http://venturereporter.net/mergers.asp?c=LWBCIPL6
http://www.thetsector.com/displayarticle5840.html
http://atlas.pharmalicensing.com/news/headlines/1065019024_3f7ae690a8c4a
Vital Therapies acquires assets of VitaGen
2 Oct 2003
Vital Therapies, Inc. has acquired the assets of VitaGen,
Incorporated, to continue the development of ELAD(R) (Extracorporeal
Liver Assist Device), a therapeutic device for the treatment of liver
failure. ELAD has demonstrated promising results to date in Phase I
and II clinical trials. VTI plans to restart the ELAD clinical program
with a new management team and revised clinical strategy to expedite
development and commercialization of the device. Financial terms of
the deal were not disclosed.
http://bms.brown.edu/curriculum/b108/liver/vitagenpg.htm
VitaGen Inc.’s Extracorporeal Liver Assist Device (ELAD®)
VitaGen company website: http://www.vgen.com/
--------------------------------------------
http://www.multicelltechnologies.com/54/
BioArtificial Liver Assist Devices
MultiCell's scientists have extensive experience in the development
and testing of hepatocyte-catalyzed liver assist devices. MultiCell
is currently working with Xenogenics, an Exten Industries Company, to
develop an engineered liver cell line specific to the Sybiol™
BioArtificial Liver Assist Device. The Sybiol BioArtificial Liver
System may provide a bridge to transplantation for patients awaiting
organ donation or for some patients obviate liver transplantation
altogether.
-------------------------------------------------
http://www.fairviewtransplant.org/advance_tech.asp
State of the Art—Nov 2000
Advancing Transplant Technology
by John Lake, MD
Liver Transplant Program Director
Patients suffering from acute liver failure and awaiting transplants
may soon be able to increase their chances of survival because of a
device developed by researchers at Fairview-University Medical Center.
The researchers developed a bioartifical liver that processes toxins
in the blood—one of many chemical procedures that occurs in the liver,
along with making cholesterol, bile and blood-clotting factors and
processing protein, sugar and fat from the digestive tract—and turns
them into harmless compounds.
Each year, about 1,000 healthy Americans develop acute liver failure.
This fast-acting type of liver failure is caused by ingesting poison,
or excessive doses of acetaminophen (Tylenol) or by a viral infection
that attacks the liver (Hepatitis).
Currently, research studies with the bioartificial liver have been
conducted exclusively on animals. However, Sielaff is awaiting
approval from the United States Food and Drug Administration (FDA) to
begin clinical trials on the bioartifical liver. The trials will focus
on previously healthy patients who suffer acute liver failure. When
clinical trials begin, Sielaff says, “We hope to treat as many as 15
patients over the next year and a half.”
-------------------------------------------------
http://www.isletmedical.com/company_1competition.htm
www.circebio.com
Circe Biomedical, Inc.
99 Hayden Avenue
Lexington, Massachusetts 02421-7995
1 (781) 863-8720
This company developed bio-artificial organs. At this time their
primary effort is in their bio-artificial liver project (HepatAssist
System). Their bio-artificial pancreas program (PancreAssist
Bio-artificial Pancreas System) is on hold.
Circe Biomedical (together with the New England Deaconess Hospital)
Pursued a program with pig islets and a vascularized device (Diabetes,
45, pp. 342-347, 1996). This work lead to an FDA authorization to
initiate clinical studies with pig islets and the device. During one
of the last pre-clinical transplants the device failed leading to the
death of the animal and the program was placed on clinical hold.
http://www.medtech1.com/companies/companies20.cfm/CE48C662-8A22-45CE-ACC6-568109158F91
Circe Biomedical, Inc., is dedicated to the development, production,
and commercialization of bioartificial organ systems, which use living
cells to provide life saving solutions for critical medical needs.
Circe has programs for the development of bioartificial organ systems
to treat liver failure and insulin dependent diabetes. Circe’s core
technologies include the isolation, purification, and cryopreservation
of primary mammalian cells, as well as the fabrication of synthetic
membrane materials that permit the selective passage of biomolecules,
and the integration of these technologies into biomedical organ
systems, designed to replace, regenerate, or supplement organ
function. The HepatAssist™ Liver Support System, Circe’s lead product
in development, is an extracorporeal, bioartificial liver that
incorporates membrane fabrication, porcine hepatocyte isolation, and
cryopreservation technologies.
http://buy.windhover.com/cgi-bin/SoftCart.exe/scstore/p-1999900071.html?E+scstore
Circe Biomedical Inc.
Circe Biomedical has developed a bioartificial liver support system
that could serve as an alternative to transplant.
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