EUCTR2005-000837-39-DEActive, not recruitingNot Applicable
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 transplantation
Cytonet GmbH & Co. KG0 sites90 target enrollmentStarted: January 2, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
- •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
Investigators
Similar Trials
Active, not recruiting
Not Applicable
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 transplantatioAcute Liver FailureSubgroups of patients with indications falling under ICD classification codes:K70.4, K71, K72, K75, K76, K77MedDRA version: 9.1Level: LLTClassification code 10049844Term: Acute liver failureEUCTR2005-000837-39-GBCytonet GmbH & Co. KG90
Active, not recruiting
Not Applicable
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 transplantationEstudio abierto, aleatorizado, prospectivo controlado y multicéntrico para la evaluación de la efectividad y la seguridad de la administración reiterada de una suspensión de células hepáticas por la vena porta a pacientes con insuficiencia hepática aguda para los que no es factible efectuar un trasplante ortotópico de hígadoInsuficiencia hepática aguda (IHA) Subgrupos de pacientes con indicationes según ICD classification codes: K70.4, K71, K72, K75, K76, K77MedDRA version: 9.1Level: LLTClassification code 10049844Term: Acute liver failureEUCTR2005-000837-39-ESCytonet GmbH & Co. KG90
Recruiting
Phase 3
Maternal oxygen therapy during pregnancy for unborn babies with underdeveloped structures on the left side of the heart2024-512679-11-00Universitaetsklinikum Erlangen AöR64
Recruiting
Phase 1
Maternal oxygen therapy during pregnancy for unborn babies with underdeveloped structures on the left side of the heartunborn baby with developmental disorder of the left side of the heartMedDRA version: 20.0Level: PTClassification code: 10021076Term: Hypoplastic left heart syndrome Class: 100000004850CTIS2024-512679-11-00niversitaetsklinikum Erlangen AöR64
Active, not recruiting
Not Applicable
Open, Prospective, Controlled, Randomised, Multicenter Phase II Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 versus Moist Wound Healing Dressing alone in Accelerating the Epithelialization of Split Thickness Skin Graft Donor SitesOleoSplit-Trial - OleoSplit-TrialEs handelt sich um eine offene, prospektive, kontrollierte, randomisierte, multizentrische Studie der Phase II, die eine intra-individuelle Wirksamkeit und Verträglichkeit des Oleogel-S10 mit einer feuchten Wundauflage im Hinblick auf einen Beschleunigung der Epithelialisierung der Wunde nach der Entnahme von Spalthaut mit einander vergleicht.EUCTR2009-017418-56-DEBirken GmbH80