Open, randomized, prospective, controlled, multicentre study to evaluate the efficacy and safety of multiple intraportal applications of liver cell suspension in patients with acute liver failure not eligible for orthotopic liver transplantatio

• Conditions: Acute Liver FailureSubgroups of patients with indications falling under ICD classification codes:K70.4, K71, K72, K75, K76, K77; MedDRA version: 9.1Level: LLTClassification code 10049844Term: Acute liver failure

• Registration Number: EUCTR2005-000837-39-GB
• Lead Sponsor: Cytonet GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age 18 years and above
• Patient suffering from ALF defined as
- Hepatic encephalopathy grade >= 1
- INR > 2,0
- GOT, GPT and GLDH increased by at least 3 times UNL in absence of signs of
chronic liver disease ( = no fibrosis or cirrhosis)
• Patient expected to be not eligible for orthotopic liver transplantation
• Written informed consent before enrolment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Acute liver insufficiency in presence of symptomatic chronicliver disease (fibrosis or
cirrhosis of the liver)
- Acute liver failure in case of transplant primary non-function
- Acute liver failure due to Budd-Chiari-Syndrome or venoocclusive disease
- Thrombosis of portal vein or persisting impairment of anterograde portal blood flow
- Allergic disposition for antibiotics used during manufacturing of liver cell transplants
- Encephalopathy other than hepatic
- Massive ascites (> 3 l)
- Malignancies except basaliomes
- Clinically manifest acquired immunodeficiency syndrome (AIDS)
- Contraindication to immunosuppressive therapy (e.g. severe acute bacterial, viral
or fungal infection, intolerability to immune suppression)
- Treatment with extracorporeal liver assist devices (e.g. MARS,
- Prometheus, HepatAssist)
- Pregnancy or lactation
- Participation in another clinical trial within the last 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified