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    Summary
    EudraCT Number:2012-005628-13
    Sponsor's Protocol Code Number:IRRB/34/12
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-01-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-005628-13
    A.3Full title of the trial
    Transplantation of Human Fetal Liver Cells for the Treatment of Patients with Decompensated Liver Cirrhosis
    Trapianto di cellule epatiche fetali umane per il trattamento della cirrosi epatica scompensata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Transplantation of Human Fetal Liver Cells for the Treatment of Patients with Chronic Liver Disease
    Trapianto di cellule epatiche fetali umane per il trattamento della malattia cronica di fegato
    A.3.2Name or abbreviated title of the trial where available
    HFLTX
    HFLTX
    A.4.1Sponsor's protocol code numberIRRB/34/12
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUPMC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISMETT
    B.5.2Functional name of contact pointDipartimento di Medicina
    B.5.3 Address:
    B.5.3.1Street AddressVia E.Tricomi 5
    B.5.3.2Town/ cityPalermo
    B.5.3.3Post code90127
    B.5.3.4CountryItaly
    B.5.4Telephone number00390912192111
    B.5.6E-mailfvenuti@ismett.edu
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namehuman fetal hepatocytes
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namehuman fetal hepatocytes
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typepreparato cellulare
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    liver cirrhosis
    cirrosi epatica
    E.1.1.1Medical condition in easily understood language
    chronic liver disease
    malattia cronica di fegato
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10019669
    E.1.2Term Hepatic fibrosis and cirrhosis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019641
    E.1.2Term Hepatic cirrhosis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10019664
    E.1.2Term Hepatic failure and associated disorders
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10019805
    E.1.2Term Hepatobiliary disorders
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Verify the efficacy of human fetal liver progenitor cell transplantation by monitoring specific and standard parameters of liver function.
    Verificare l’efficacia terapeutica del trapianto di cellule progenitrici epatiche fetali umane monitorando paramentri standard e specifici di funzionalità epatica.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of fetal liver progenitor cell transplantation on portosystemic encephalopathy (also minimal) in patients with liver cirrhosis.
    Valutare gli effetti sull’encefalopatia (anche minima) del trapianto di cellule progenitrici epatiche fetali nei pazienti cirrotici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Clinical diagnosis (evidence of chronic liver disease, presence of ascites and/or esophageal varices upon upper digestive endoscopy and/or ultrasound evidence of portal hypertension) or histological diagnosis of liver cirrhosis of any etiology. b) Liver failure documented by a score ≥ B8 based on the Child-Pugh classification, and MELD score ≥ 15. c) Informed consent to the study signed by the patient.
    a) Diagnosi clinica (segni obiettivi di malattia cronica di fegato, presenza di ascite e/o varici esofagee all endoscopia digestiva superiore e/o segni ecografici d ipertensione portale) o istologica di cirrosi epatica con qualsiasi eziologia. b) Insufficienza epatica documentata da un punteggio minimo di B8 sulla base della classificazione Child- Pugh-Turcotte e punteggio MELD ≥15 (punteggio soglia correlato, sulla base delle evidenze attualmentedisponibili, al beneficio del trapianto. c) Consenso informato allo studio firmato dal paziente
    E.4Principal exclusion criteria
    • MELD score > 28 • Hepatocellular carcinoma (HCC) • Portal vein thrombosis • Serious cardiovascular or respiratory disease, or other medical condition which may threaten patient’s life in the subsequent three months • Admission to the intensive care unit (ICU) • Hemodynamic instability (MAP < 55 mmHg) • Use of vasoactive drugs (e.g., epinephrine, norepinephrine, vasopressin, dopamine, terlipressine) • Type-1 (acute) hepatorenal syndrome • Levels of serum creatinine >2 mg/dl and/or creatinine clearance <30-40 ml/min • Sepsis, active infection or spontaneous bacterial peritonitis • Gastrointestinal bleeding or recent gastrointestinal bleeding episode (in the previous 4 weeks) • Consumption of alcohol • Serious alcoholic hepatitis • Pulmonary hypertension (PAP > 35 mmHg) • History of neoplasia • Pregnancy • Non-Sicilian residency • HBV DNA positive • HIV infection • Drug addiction • Age < 18 years • Partecipation in concomitant studies • Transjugular intrahepatic portosystemic shunt (TIPS) placed in the previous three months • Contraindications to the procedure (i.e., related to the splenic artery: aneurysm, kinking, thrombosis, thrombosis; related to the spleen: large angioma).
    Meld score &gt; 28 Epatocarcinoma Trombosi della vena porta Grave patologia cardiovascolare o respiratoria ovvero altra condizione medica che metta potenzialmente a rischio la vita del paziente nei successivi 3 mesi Ammissione in terapia intensiva Instabilità emodinamica (MAP &lt; 55 mmHg) Uso di farmaci vasoattivi (Epinefrina, Norepinefrina, Vasopressina, Dopamina, Terlipressina) Sindrome epatorenale di tipo I (acuta) Livello di creatinina sierica &gt;2 mg/dl e/o clearance della creatinina &lt;30-40 ml/min Sepsi, infezione attiva o peritonite batterica spontanea Emorragia gastrointestinale in atto o episodio recente di emorragia gastrointestinale (nelle 4 settimane precendenti) Abuso di sostanze alcoliche in atto Grave epatite alcolica Ipertensione polmonare (PAP &gt; 35 mmHg) Storia di neoplasia Gravidanza Pazienti non residenti in Sicilia HBV DNA positivo Infezione da HIV Tossicodipendenza Età &lt; 18 anni Posizionamento di shunt intraepatico porto-sistemico (TIPS) prima dei tre mesi precedenti. Partecipazione concomitante ad altri studi Controindicazioni alla procedura (ad esempio relative all arteria splenica: aneurisma, inginocchiamento, trombosi; relative alla milza: angioma di grosse dimensioni).
    E.5 End points
    E.5.1Primary end point(s)
    - Stabilization or reduction of the MELD score of 25% compared with pretreatment. Evaluation of the response will be made at intervals after the first infusion of hepatocytes, and at the end of the study.
    Stabilizzazione o riduzione dello score di MELD del 25% rispetto a quello pre-trattamento. La valutazione della risposta sarà effettuata ad intervalli dopo la prima infusione di epatociti e alla fine dello studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    un anno
    E.5.2Secondary end point(s)
    Disappearance of systemic encephalopathy (also minimal).
    Scomparsa dell’encefalopatia porto-sistemica (anche minima).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year
    un anno
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    terapia cellulare
    cell therapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Clinical surveillance
    Sorveglianza clinica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-07-24
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