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| Sponsor: | Vital Therapies, Inc. |
|---|---|
| Information provided by: | Vital Therapies, Inc. |
| ClinicalTrials.gov Identifier: | NCT00832273 |
Purpose
VTI has established two clinical protocols to study the effects of ELAD® plus standard therapy compared with standard therapy alone in patients with AOCH (VTI-201) and FHF (VTI-202). However LF patients who do not qualify for VTI-201 and VTI-202 may benefit from ELAD® use. In order to accommodate physician requests for the use of ELAD® in LF patients who do not qualify for Protocols VTI-201 and VTI-202 without the need to resort to individual Emergency Use INDs for each case, VTI has developed a Treatment Protocol with Cost Recovery as described below, to provide for expanded access to ELAD® for those with LF. This uncontrolled Treatment Protocol has been designed to provide expanded access to ELAD® in subjects with LF while assuring that sufficient data are collected to adequately monitor ELAD® safety when used in this setting at multiple centers in the United States.
| Condition | Intervention |
|---|---|
|
Liver Failure |
Other: Standard of Care Device: ELAD® |
| Study Type: | Expanded Access What is Expanded Access? |
| Official Title: | Use of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Liver Failure: Uncontrolled Treatment Protocol to Provide Expanded Access With Cost Recovery |
Conventional therapies such as hemodialysis and hemoperfusion do not correct the metabolic abnormalities that are the hallmark of acute liver failure. Biologically active devices have heretofore been impractical because of limitations in the availability and viability of cultured liver cells of non-human origin. The yield of viable hepatocytes obtained for such purposes from large animals has been disappointing.
Vital Therapies Incorporated has developed an Extracorporeal Liver Assist Device (ELAD®) system that is comprised of a dialysis-type pump system and several "metabolically active" cartridges, each containing thousands of hollow fiber capillaries through which the subject's plasma "ultrafiltrate" fluid is circulated. Within each cartridge chamber, cloned immortalized human liver cells (C3A cells, U. S. patent #5,290,684) are grown in the extracapillary space (ECS) of the hollow fibers. These cells have been shown to exhibit certain characteristics of normal liver cells (e.g. albumin synthesis, conversion of ammonia to urea, synthesis of coagulation factors such as factor V etc.) and to be free of infectious or adventitious agents. During clinical therapy, the subject's ultrafiltrate (plasma-like) is pumped through the lumen (intracapillary space {ICS}) of the hollow fiber cartridge, and presumably, toxins found in the ultrafiltrate diffuse across the membrane where they can be metabolized by the C3A cells. These metabolites, along with albumin and other beneficial proteins produced by the cells, can then diffuse back across the membrane into the ICS and be returned to the subject. ELAD® therapy is designed to provide continuous liver support to a subject with compromised liver function, allowing time for the subject's native liver to regenerate to a healthy state, or to stabilize the subject until a suitable donor organ can be found for transplantation.
Eligibility| Ages Eligible for Study: | 10 Years to 70 Years |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Cerebral Perfusion Pressure as measured by an intracranial pressure (ICP) monitor. (NOTE: In those cases where ICP monitor placement cannot be performed prior to study enrollment, this exclusion criterion will not apply):
Contacts and Locations| United States, Michigan | |
| University of Michigan Hospital | |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: | Lena Napolitano, MD | University of Michigan Hospital |
More Information
| Responsible Party: | Robert Ashley, Chief Operating Officer, Vital Therapies, Inc. |
| ClinicalTrials.gov Identifier: | NCT00832273 History of Changes |
| Other Study ID Numbers: | VTI-501 |
| Study First Received: | January 29, 2009 |
| Last Updated: | May 25, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Expanded access to ELAD® in patients with liver failure |
|
Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases |