Trials / Unknown
UnknownNCT03084198
Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- Shanghai East Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.
Detailed description
Liver damage remains a life-threatening syndrome. With the increasing number of patients awaiting transplantation, efforts have been made to develop extracorporeal methods to support or replace the function of the failing organ. A bioartificial liver support system has to provide the main functions of the liver: detoxification, synthesis, and regulation. It may prolonger the expected survival time of acute liver failure patients. Direct reprogramming of fibroblasts to hepatic lineages could offer a new type of solution to bioartificial liver support system. The investigators have already generated human induced hepatocytes (hiHeps) from fibroblasts by lentiviral expression of FOXA3, HNF1A, and HNF4A. hiHeps express hepatic gene programs, can be expanded in vitro, and display functions characteristic of mature hepatocytes, including cytochrome P450 enzyme activity and biliary drug clearance. hiHeps can restore the liver function and prolong survival. This study tends to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | hiHep Bioartificial Liver Support System | Continuous treatment with the hiHep bioartificial liver support system for a minimum of 3 days to a maximum of 14 days. The subject's ultrafiltrated blood is circulated through 4 cartridges. The parameter is set to Circuit 1：120-200ml/min；Circuit 2：30-50ml/min；Circuit 3：200 ml/min. |
| PROCEDURE | Standard care for ALF | A standard of care for subjects with acute liver failure. |
Timeline
- Start date
- 2017-06-01
- Primary completion
- 2020-06-01
- Completion
- 2020-06-01
- First posted
- 2017-03-20
- Last updated
- 2017-04-25
Source: ClinicalTrials.gov record NCT03084198. Inclusion in this directory is not an endorsement.