Flag of the European Union EU Clinical Trials Register Help

Clinical trials for 2017-003989-27

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44366   clinical trials with a EudraCT protocol, of which   7389   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    2 result(s) found for: 2017-003989-27. Displaying page 1 of 1.
    EudraCT Number: 2017-003989-27 Sponsor Protocol Number: PROLONGSTEM Start Date*: Information not available in EudraCT
    Sponsor Name:Promethera Therapeutics
    Full Title: PROLONGSTEM: HepaStem Long-Term Safety Registry Registry for patients who have been administered HepaStem
    Medical condition: This study will include all patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HALPC during a previous interventional clinical study conducted by...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10021601 Inborn error of metabolism NOS LLT
    20.0 100000004871 10008954 Chronic liver disease and cirrhosis LLT
    20.1 100000004871 10049844 Acute liver failure LLT
    21.1 200000003094 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) GB (GB - no longer in EU/EEA) BG (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004449-18 Sponsor Protocol Number: HEP201 Start Date*: 2019-04-10
    Sponsor Name:Promethera Biosciences
    Full Title: Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steatohepatitis (NASH).
    Medical condition: NASH is characterized by steatosis, inflammation and cytological ballooning with varying amounts of fibrosis. Patients with NASH are at risk of cardiovascular morbidity and mortality. In chronic li...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10031743 Other chronic nonalcoholic liver disease LLT
    20.0 10019805 - Hepatobiliary disorders 10019708 Hepatic steatosis PT
    20.0 10019805 - Hepatobiliary disorders 10041970 Steatosis hepatic LLT
    20.0 10019805 - Hepatobiliary disorders 10019669 Hepatic fibrosis and cirrhosis HLT
    20.0 10019805 - Hepatobiliary disorders 10009211 Cirrhosis liver LLT
    20.0 10019805 - Hepatobiliary disorders 10024667 Liver cirrhosis LLT
    20.0 10019805 - Hepatobiliary disorders 10009213 Cirrhosis of liver LLT
    20.1 10019805 - Hepatobiliary disorders 10064704 Decompensated cirrhosis LLT
    20.1 10019805 - Hepatobiliary disorders 10064844 Compensated cirrhosis LLT
    20.1 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    20.0 10019805 - Hepatobiliary disorders 10076331 Steatohepatitis PT
    20.0 10019805 - Hepatobiliary disorders 10019641 Hepatic cirrhosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) BG (Completed) PL (Completed) ES (Ongoing) RO (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Jan 01 16:45:22 CET 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA