On April 22, 2005, Arbios received FDA approval for a clinical trial to test SEPET(TM)'s safety and tolerability in patients with acute exacerbation of chronic liver failure.
SEPET (selective plasma filtration therapy) is a single-use cartridge that contains specially designed porous tubes, serving as a blood detoxification measure to provide temporary liver support during acute liver failure and acute exacerbation of chronic liver disease. SEPET-therapy will be provided through a single-use, disposable cartridge containing a bundle of hollow fibers made of a bio- and hemo-compatible material, capable of sieving substances with molecular weight of up to 100 kDa. When patient's blood is pumped through these fibers, substances normally metabolized by the liver and accumulated in the blood during liver failure move across the porous wall and are discarded. Depending on individual patients needs, electrolyte solution, human albumin solution, fresh frozen plasma or a combination thereof is used as a replacement fluid.
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- James on HubMed: PubMed rewired
- Regulatory Consulting on TRM Awards 2008: Funding for up to 20 awards and research groups
- Regulatory Consulting on Arbios: FDA approval for SEPET clinical trial
- Regulatory Affairs Consultant on Gambro receives 510(k) clearance for MARS for drug overdose and poisoning treatment
- Clinical Trial Regulations on Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET™
- International Regulatory Affairs on Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET™
- Elaina on Small sections of human liver have been created from umbilical cord stem cells
- x-ray fluorescence on TRM Awards 2008: Funding for up to 20 awards and research groups
- Paolo Manzelli on ESAO Board of Governors - I.M. Sauer elected
- Dr.Muhammad Asad Ullah on ESAO 2007 - Krems, Austria, September 5-8, 2007
Recent Posts
- PhD Student Award in Regenerative Medicine
- Sep 1, 2008 3:36:00 PM
- The ESAO One Day on the Liver 2008 in Geneva - Thursday, Sept. 4th, 2008
- TRM Awards 2008: Funding for up to 20 awards and research groups
- HepaWash and II. Medical Department, University Hospital rechts der Isar awarded € 425,000 grant from the Bayerische forschungsstiftung (BFS) for a € 0.9 Mio collaborative Preclinical study on Acute liver Failure
- Recent reviews in the field of liver support
- Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET™
- Biological scaffolds for tissue engineering
- First World Bioprinting Congress
- ESAO Board of Governors - I.M. Sauer elected
Medgadget
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Artificial Organs
Webpages
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May 03, 2005
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Good post!!!!!!! Thank you.........
Posted by: Regulatory Consulting | May 25, 2009 at 09:34