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-DE
• Lead Sponsor: Cytonet GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

• Age 18 years and above
•Written informed consent before enrolment
•Patient suffering from ALF manifested as
- Hepatic encephalopathy grade ? I (grade = III for patients with ALF
due to acetaminophen poisoning)
- INR = 2.3* OR INR = 1.5 together with MELD Score = 25*
- GOT, GPT and GLDH increased by at least 3 times UNL in absence of
signs of chronic liver disease ( = no fibrosis or cirrhosis)
•Patient not eligible for orthotopic liver transplantation
•Onset of first symptom(s) of liver failure less than 12 weeks ago
•No anticoagulative therapy within the last 72 hours before the two
consecutive measurements mentioned (*)
•No clinically significant brain oedema
•No manifest sepsis
•No haemodynamic instability
•No massive bleeding
•No multiorgan failure (lung, kidney, heart affected)
*determined in two consecutive measurements after a 8-12 hours time span (14 hours must not be exceeded)
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 chronic liver 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 veno-occlusive 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) except there is
•no evidence of disease within the last 2 years
•or all of the following:
- stable condition after tumor therapy (i.e. tumor in remission and life
expectancy is > 6 months)
- liver failure is not due to malignant disease and/or to therapy thereof
- no manifestation of malignant disease within the liver (to be excluded
by CT)
•Clinically manifest acquired immunodeficiency syndrome (AIDS)
•Allergy to contrast medium
•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