Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

UNC to test new assist device for failed livers

12.03.2003




Prospects for surviving acute liver failure are very slim, and statistics place mortality as high as 90 percent. A liver transplant may be the only alternative before fatal complications set in, yet not enough donor organs are available to meet the demand.

But a new bio-artificial technology about to undergo clinical tests at the University of North Carolina at Chapel Hill and several other centers nationally may help extend the lives of those awaiting a donor liver and may even allow the damaged liver to heal itself completely.

Known by its acronym ELAD, the extracorporeal liver assist device is the first such technology to contain functioning human hepatocytes, liver cells that help sustain and support the work of the patient’s damaged and failed organ. Other liver assist systems use hepatocytes from pigs.



The new device is a closed system to which patients are tethered via a catheter inserted into a vein in the neck. After the blood is initially filtered, the remaining plasma goes through cartridges in the ELAD where the human hepatocytes help fulfill much of the liver’s 100 or so crucial functions, such as energy storage and regulation, bile production, blood detoxification, production of clotting factors and many essential proteins. The filtered blood and ELAD-treated plasma are returned to the patient.

Dr. Roshan Shrestha, associate professor of medicine and medical director of the liver transplantation program at UNC, said ELAD could provide two major benefits.

"This device could serve as a bridge to successful transplantation, helping to sustain patients awaiting a donor organ."

It also may enable complete recovery, he added.

"A remarkable feature of the liver is its capacity to regenerate. If we can sustain acute liver failure patients early on, right from the beginning, they may not need transplantation and may recover without any significant liver problems, including chronic liver disease."

Shrestha, principal investigator for the UNC study site, said a first-phase clinical trial conducted in the United States and Great Britain during 1999 and 2000 showed promising results. In that study, sponsored by ELAD maker Vitagen Inc., 11 of 12 (91.6 percent) of patients who had been randomized to receive treatment with the new device achieved either a successful bridge to transplantation or full recovery. In a control group of patients receiving standard care, three of seven (42 percent) achieved those benefits.

In an analysis of overall results in 25 patients, including those not listed for liver transplantation, 13 of 16 (81 percent) improved on the device, compared to only five of nine (51 percent) in the control group.

Shrestha said the U.S. Food and Drug Administration was sufficiently pleased with the results to give its nod to a second-phase trial, also sponsored by Vitagen. Safety and effectiveness, including survival at 30 days, is the main endpoint, Shrestha said.

"The primary objective is to evaluate the safety, efficacy and tolerability of the ELAD system in patients with acute hepatic [liver] failure. Our secondary objective is to evaluate the study protocol with respect to patient inclusion and exclusion criteria and to study the system’s performance with regard to endpoints." Total enrollment for this trial is between 30 and 40 patients. A larger third-phase trial may follow, with an enrollment of at least 200 people with acute liver failure.

"Currently, we don’t have very good therapies for patients with acute liver failure. That’s why we’re hoping that the new technology will make a big difference," Shrestha said. "The bottom line is to save lives."


Note: Contact Shrestha at (919) 843-9459 or (919) 966-2516 (choose option "O"), or r_shrestha@med.unc.edu.

School of Medicine contact: Les Lang, (919) 843-9687 or llang@med.unc.edu


Leslie H. Lang | EurekAlert!
Further information:
http://www.med.unc.edu/

More articles from Health and Medicine:

nachricht Deep stimulation improves cognitive control by augmenting brain rhythms
04.04.2019 | Picower Institute at MIT

nachricht Black nanoparticles slow the growth of tumors
04.04.2019 | Technische Universität München

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Explosion on Jupiter-sized star 10 times more powerful than ever seen on our sun

A stellar flare 10 times more powerful than anything seen on our sun has burst from an ultracool star almost the same size as Jupiter

  • Coolest and smallest star to produce a superflare found
  • Star is a tenth of the radius of our Sun
  • Researchers led by University of Warwick could only see...

Im Focus: Quantum simulation more stable than expected

A localization phenomenon boosts the accuracy of solving quantum many-body problems with quantum computers which are otherwise challenging for conventional computers. This brings such digital quantum simulation within reach on quantum devices available today.

Quantum computers promise to solve certain computational problems exponentially faster than any classical machine. “A particularly promising application is the...

Im Focus: Largest, fastest array of microscopic 'traffic cops' for optical communications

The technology could revolutionize how information travels through data centers and artificial intelligence networks

Engineers at the University of California, Berkeley have built a new photonic switch that can control the direction of light passing through optical fibers...

Im Focus: A long-distance relationship in femtoseconds

Physicists observe how electron-hole pairs drift apart at ultrafast speed, but still remain strongly bound.

Modern electronics relies on ultrafast charge motion on ever shorter length scales. Physicists from Regensburg and Gothenburg have now succeeded in resolving a...

Im Focus: Researchers 3D print metamaterials with novel optical properties

Engineers create novel optical devices, including a moth eye-inspired omnidirectional microwave antenna

A team of engineers at Tufts University has developed a series of 3D printed metamaterials with unique microwave or optical properties that go beyond what is...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Revered mathematicians and computer scientists converge with 200 young researchers in Heidelberg!

17.04.2019 | Event News

First dust conference in the Central Asian part of the earth’s dust belt

15.04.2019 | Event News

Fraunhofer FHR at the IEEE Radar Conference 2019 in Boston, USA

09.04.2019 | Event News

 
Latest News

New automated biological-sample analysis systems to accelerate disease detection

18.04.2019 | Life Sciences

Explosion on Jupiter-sized star 10 times more powerful than ever seen on our sun

18.04.2019 | Physics and Astronomy

New eDNA technology used to quickly assess coral reefs

18.04.2019 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>