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    Summary
    EudraCT Number:2019-003051-11
    Sponsor's Protocol Code Number:HEP102
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-06
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-003051-11
    A.3Full title of the trial
    Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with Acute on Chronic Liver Failure (ACLF) - DHELIVER
    Estudio aleatorizado, controlado con placebo, doble ciego, multicéntrico de fase IIb para evaluar la eficacia y seguridad de HepaStem en pacientes con insuficiencia hepática aguda y crónica (ACLF) - DHELIVER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This trial will evaluate the safety and efficacy of HepaStem compared to placebo in patients with a cirrhotic liver condition called Acute on Chronic Liver Failure (ACLF). The study will be performed in multiple centers and in a double-blinded manner, meaning neither the patients nor the treating physicians know who is on placebo or the study drug.
    Este ensayo evaluará la seguridad y eficacia de HepaStem en comparación con placebo en pacientes con una afección hepática cirrótica llamada Insuficiencia hepática aguda en crónica (ACLF). El estudio se realizará en múltiples centros y de una manera doble ciego, lo que significa que ni los pacientes ni los médicos tratantes saben quién está en placebo o el fármaco del estudio.
    A.3.2Name or abbreviated title of the trial where available
    HEP102 - DHELIVER
    A.4.1Sponsor's protocol code numberHEP102
    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 SponsorPromethera Biosciences
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPromethera Biosciences
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationComac Medical
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Addressto complete
    B.5.3.2Town/ cityto complete
    B.5.3.3Post code1618
    B.5.3.4CountryBulgaria
    B.5.4Telephone number+3210394300
    B.5.5Fax number+3210394301
    B.5.6E-mailRegulatory@promethera.com
    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 nameHepaStem
    D.3.2Product code HALPC
    D.3.4Pharmaceutical form Dispersion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman allogenic liver-derived progenitor cells
    D.3.9.2Current sponsor codeHALPC
    D.3.9.3Other descriptive nameHuman allogenic liver-derived progenitor cells
    D.3.9.4EV Substance CodeSUB199771
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 50
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberTissue engineered product (EMA/CAT/391889/2016) in the treatment of fibroinflammatory liver diseases.
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cirrhotic patients who are hospitalized for Acute on chronic liver failure (ACLF), ACLF combines an acute deterioration of liver function in an individual with pre-existing chronic liver disease and extrahepatic organ failures characterized by high short-term mortality (30-40% at 28days). The development of ACLF is associated with exacerbated systemic inflammation that may indeed cause organ failures.
    Pacientes cirróticos que están hospitalizados por insuficiencia hepática aguda sobre cronica (ACLF), que combina el deterioro agudo de la función hepática en un individuo con enfermedad hepática crónica preexistente y fallas orgánicas extrahepáticas. Se caracteriza por una alta tasa de mortalidad en el corto plazo (30-40% al cabo de 28 días). El deterioro por ACLF está asociado con una inflamación sistémica exacerbada que de hecho puede causar fallas en otros órganos.
    E.1.1.1Medical condition in easily understood language
    ACLF is an acute deterioration of liver function in an individual with cirrhosis and organ failures with systemic inflammation and high short term mortality.
    ACLF es un deterioro agudo de la función hepática en un individuo con cirrosis y fallas orgánicas múltiples, inflamación sistémica y alta tasa de mortalidad en el corto plazo.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008954
    E.1.2Term Chronic liver disease and cirrhosis
    E.1.2System Organ Class 100000004871
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10049844
    E.1.2Term Acute liver failure
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate the efficacy of 2 infusions (i.v.) of HepaStem at 1.0 million of cells/kg (7-day interval) on the overall survival proportion 90 days post-first infusion.
    El objetivo primario es demostrar la eficacia de 2 infusiones (i.v.) de HepaStem a 1,0 millones de células/kg (en un intervalo de 7 días) en proporción de la supervivencia global 90 días posteriores a la primera infusión.
    E.2.2Secondary objectives of the trial
    1. Safety of 2 infusions (i.v.) of HepaStem at 1.0 million of cells/kg (7-day interval).
    2. Efficacy on the transplant-free survival proportion 90 days post-first infusion.
    3. Efficacy on the overall survival, transplant-free survival, and post-transplant survival proportion up to 1-year post-infusion.
    4. Efficacy on the liver function parameters, such as the MELD score and bilirubin levels, up to 1-year post-infusion.
    5. Efficacy on the inflammatory parameters, up to 1-year post-infusion.
    6. Efficacy on the transplant proportion, the duration of hospitalization in ICU, the duration of the overall hospitalization, the number of
    rehospitalization for ACLF, liver function, Quality of Live (QoL), and Investigator's and patient's opinion on the IMP.
    Exploratory: Efficacy on the survival proportion 90 days post-first infusion based on ACLF grading defined by IHDST NACSELD ACLF criteria.
    1. Seguridad 2 infusiones (i.v.) HepaStem 1,0 millones de cel/kg (7 días).
    2. Eficacia en proporción supervivencia sin trasplante 90 días posterior a infusión.
    3. Eficacia en proporción a supervivencia global, sin y postrasplante en 1 año.
    4. Eficacia a 1 año post infusion según parámetros de función hepática, puntuación MELD y niveles de bilirrubina.
    5.Eficacia según parámetros inflamatorios, hasta 1 año después infusión.
    6. Eficacia en proporción a trasplantes, duración hospitalización, total de hospitalizaciones y número rehospitalizaciones por ACLF, función hepática, calidad de vida, opinión investigador y paciente.
    Exploratorios: Eficacia en proporción a la supervivencia 90 días posterior a la infusión según criterio ACLF del IHDST y NACSELD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must fulfil all of the following criteria in order to be eligible for trial enrolment:
    1. Adult aged 18 years and above.
    2. Initial diagnostic of ACLF, at the investigational site, maximum 3 days before signature of the ICF.
    3. Patient with Acute on Chronic Liver Failure Grade 1 or 2 according to the CLIF definition*.
    4. Bilirubin value ≥5 mg/dL.
    5. Signed Informed Consent.
    N.B: In case of hepatic encephalopathy, if the patient is not able to fully understand the study based on the investigator's judgment, the Informed Consent must be signed by a patient's legal or authorized representative according to local regulation, and by the patient, if possible, after encephalopathy improvement.
    * ACLF grading is based on the number of organ failure as defined per the CLIF-OF score (Arroyo et al. 2015); http://www.efclif.com/scientific-activity/score-calculators/clif-c-aclf
    Los pacientes deben cumplir todos los criterios siguientes para poder ser elegibles para la inscripción en el ensayo:
    1. Adultos de 18 años o más.
    2. Diagnóstico inicial de ACLF, en el Centro de investigación, máximo 3 días antes de la firma del consentimiento informado.
    3. Paciente con insuficiencia hepática crónica aguda grado 1 o 2 según la definición CLIF*.
    4. Valor de bilirrubina ≥ 5 mg/dl.
    5. Consentimiento informado firmado.
    Nota: En caso de encefalopatía hepática, si el paciente no es capaz de entender totalmente el estudio, basado en el criterio del investigador, el consentimiento informado puede ser firmado por un representante del paciente legal o autorizado de acuerdo con la normativa local, y por el paciente, si es posible, tras la mejora de la encefalopatía.
    * La calificación de ACLF se basa en el número de insuficiencias orgánicas según se define en la puntuación CLIF-OF (Arroyo et al. 2015); http://www.efclif.com/scientific-activity/score-calculators/clif-c-aclf
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. ACLF grade 3.
    2. Active uncontrolled bleeding or patient with high risk of short term bleeding up to investigator's judgment.
    3. Model for End-Stage Liver Disease (MELD) score >35.
    4. Cerebrovascular, myocardial, limb arterial thrombotic event, or history for both thrombotic and hemorrhagic cerebrovascular events within 12 months prior to the screening and not considered stabilized by the investigator.
    5. Mechanical ventilation due to respiratory failure, except for hepatic encephalopathy.
    6. Inability to maintain mean BP >60 despite use of vasopressors.
    7. Patients receiving immunosuppressive drugs, except glucocorticoids.
    8. Thrombosis of portal vein.
    9. Underlying cirrhosis due to biliary disease (primary sclerosing
    cholangitis, primary biliary cholangitis…).
    10. Underlying cirrhosis due to autoimmune hepatitis.
    11. Coagulation disturbances defined as (Drolz et al. 2016; Nadim et al. 2016):
    a. fibrinogen < 80 mg/dL
    b. platelets < 50 x 10³/mm³
    12. Uncontrolled bacterial infection upon judgment of the investigator.
    13. Proven or probable invasive aspergillosis (Gustot et al. 2014).
    14. Major invasive procedure within 2 weeks before the infusion. These are open surgeries (the proper healing of the scar should be verified by the investigator). N.B.: Liver biopsy (trans jugular or percutaneous), paracentesis, TIPS are not considered as a major invasive procedure.
    15. Previous organ transplantation and/or treatment with cells.
    16. Previous hepatectomy.
    17. Severe pulmonary arterial hypertension defined as mean pulmonary arterial pressure (MPAP) ≥45 mmHg.
    18. Hepatopulmonary syndrome.
    19. Known or suspected hypersensitivity or allergy to any of the components of the HepaStem Diluent (human albumin, heparin sodium and sodium bicarbonate, DMSO), bovine serum, or a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions.
    20. Patients with active cancer or history of cancer unless adequately treated and/or in complete remission for five or more years.
    21. Hepatocellular carcinoma.
    22. On haemodialysis due to chronic kidney disease.
    23. Known infection with human immunodeficiency virus (HIV).
    24. Pregnancy (negative β-HCG test required) and nursing women, or women with childbearing potential who decline to use highly effective contraception methods during the study. Authorized methods of contraception are listed in Section 10.14.2.
    25. Participation in any other interventional study within the last 4 weeks, or participation and/or under follow-up in another clinical trial.
    26. Any significant medical or social condition or disability that, in the Investigator's opinion, may warrant a specific treatment, or may interfere with the patient's optimal participation or compliance with the study procedures.
    27. Patients who are employees of the Sponsor or investigator, or otherwise dependent on them; Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
    28. Accepted as High Urgency status patient by the organ allocation system (ex: Eurotransplant or equivalent)
    Depending on the reason of screening failures, a patient could be retested again (Visit 1 re-test) after consultation with the sponsor.
    1. ACLF de grado 3.
    2. Sangrado activo no controlado o paciente con alto riesgo de sangrado a corto plazo a juicio del investigador.
    3. Puntuación del Modelo de la enfermedad hepática terminal (MELD) > 35.
    4. Evento cerebrovascular, miocárdico o trombótico arterial de las extremidades, o historial de eventos trombóticos y cerebrovasculares hemorrágicos durante los 12 meses anteriores al cribado y/o el investigador no lo considera estabilizado.
    5. Ventilación mecánica por insuficiencia respiratoria, excepto en caso de la encefalopatía hepática.
    6. Incapacidad para mantener la tensión media > 60 a pesar del uso de vasopresores.
    7. Pacientes que toman medicamentos inmunosupresores, salvo los glucocorticoides.
    8. Trombosis de la vena porta
    9. Cirrosis subyacente por enfermedad biliar (colangitis esclerosante primaria, colangitis biliar primaria...).
    10. Cirrosis subyacente debido a hepatitis autoinmune.
    11. Las alteraciones de la coagulación se definen como (Drolz et al. 2016; Nadim et al. 2016);
    a. fibrinógeno < 80 mg/dl
    b. plaquetas < 50 x 10³/mm3
    12. Infección bacteriana no controlada a juicio del investigador.
    13. Aspergilosis invasiva probada o probable (Gustot et al. 2014).
    14. Procedimiento invasivo mayor durante 2 semanas previas a la infusión. Se trata entonces de cirugías abiertas (la cicatrización adecuada de la cicatriz debe ser comprobada por el investigador). Nota: La biopsia del hígado (transyugular o percutánea), la paracentesis y TIPS no se consideran procedimientos invasivos mayores.
    15. Tratamiento con células y/o trasplante de órganos previo.
    16. Hepatectomía previa.
    17. Hipertensión arterial pulmonar severa definida como presión arterial pulmonar media (PAPM) ≥ 45 mmHg.
    18. Síndrome hepatopulmonar.
    19. Hipersensibilidad o alergia conocida o sospechada a cualquiera de los componentes del diluyente HepaStem (albúmina humana, heparina sódica y bicarbonato de sodio, dimetil sulfóxido (DMSO), suero bovino o antecedentes de alergias múltiples y/o graves a medicamentos o alimentos o antecedentes de reacciones anafilácticas graves.
    20. Pacientes con cáncer activo o antecedentes de cáncer a menos que reciban tratamiento adecuado y/o estén en remisión completa desde hace cinco años o más.
    21. Carcinoma hepatocelular.
    22. En hemodiálisis por enfermedad renal crónica.
    23. Infección conocida con el virus de inmunodeficiencia humana (VIH).
    24. Embarazo (se requiere prueba β-GCH negativa) y mujeres lactantes, o mujeres con potencial para tener hijos que rechacen utilizar métodos anticonceptivos altamente efectivos durante el estudio. Los métodos anticonceptivos autorizados se enumeran en la Sección 10.14.2.
    25. Participación en cualquier otro estudio de intervención en las últimas 4 semanas, o participación y/o seguimiento en otro ensayo clínico.
    26. Cualquier condición o discapacidad médica o social significativa que, en opinión del investigador, pueda justificar un tratamiento específico, o pueda interferir con la participación o el cumplimiento óptimo del paciente con los procedimientos del estudio.
    27. Pacientes empleados del Patrocinador o del grupo investigador, o que dependen de ellos de alguna otra manera; pacientes comprometidos con una institución en virtud de una orden emitida por las autoridades judiciales o administrativas.
    28. Aceptado como paciente en estado de alta urgencia por el sistema de asignación de órganos (p. ej. eurotransplante o equivalente)
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival proportion at 90 days post first infusion.
    Proporción total de supervivencia a los 90 días después de la primera infusión.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days post first infusion.
    90 días después de la primera infusión.
    E.5.2Secondary end point(s)
    • Overall Survival proportion up to 1-year post first infusion.
    • Liver Transplant-free survival proportion at 90 days post first infusion.
    • Liver Transplant-free survival proportion up to 1-year post first infusion.
    • Liver transplantation-free proportion at 90 days post first infusion.
    • Liver transplantation-free proportion up to 1-year post infusion.
    • Post-liver transplant survival proportion up to 1-year post infusion.
    • Overall survival time.
    • Liver transplant-free time.
    • Liver transplant-free survival time.
    • West Haven, CLIF-OF, ACLF grade, CLIF-C ACLF score, CLIF-C AD, MELD score, Child Pugh score up to 1-year post first infusion.
    • Quantitative measurement of liver function parameters (bilirubin, AST, ALT, GGT, INR, albumin, ALP) up to 1 Year.
    • Quantitative measurement of kidney function parameters (creatinine, urea/BUN).
    • Quantitative measurement of inflammatory parameters (CRP, IL­6, IL­1β, IL­8).
    • Quantitative measurement of leukocytes and neutrophils.
    • Change in QoL questionnaires (EQ-5D-5L and SF-36 QoL) up to 1 year.
    • The duration of hospitalization in ICU, the duration of the overall hospitalization, the number of rehospitalization for ACLF, and Investigator’s and patient’s opinion on the IMP.
    Proporción total de supervivencia hasta 1 año después de la primera infusión.
    Proporción de supervivencia sin trasplante de hígado a los 90 días después de la primera infusión.
    Proporción de supervivencia sin trasplante de hígado hasta 1 año después de la primera
    Proporción sin trasplante de hígado a los 90 días de la primera infusión.
    Proporción sin trasplante de hígado hasta 1 año después de la infusión.
    Proporción de supervivencia post-trasplante de hígado hasta 1 año después de la infusión.
    Tiempo de supervivencia general.
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 1 year post first infusion.
    Hasta 1 año después de la primera infusión.
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belarus
    Belgium
    Bulgaria
    Croatia
    Denmark
    Estonia
    France
    Georgia
    Germany
    Italy
    Latvia
    Lithuania
    Macedonia, the former Yugoslav Republic of
    Netherlands
    Poland
    Portugal
    Romania
    Serbia
    Slovakia
    Slovenia
    Spain
    Turkey
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLP
    Ultima Visita del ultimo sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months34
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months34
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 290
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 73
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In case of hepatic encephalopathy, if the patient is not able to fully understand the study, the ICF must be signed by a patient's legal or authorized representative according to local regulation, and by the patient after improvement if possible.
    En caso de encefalopatía hepática, si el paciente no puede comprender completamente el estudio, el ICF sera firmado por su representante legal o autorizado de acuerdo a la legislacion, y por el paciente de ser posible posteriormente, si este mejora.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 297
    F.4.2.2In the whole clinical trial 363
    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)
    At Month 12 study visit, patients who received at least 1 infusion of HepaStem will be invited to be included in the Patient Long term follow up registry study PROLONGSTEM.
    En la visita del mes 12 , los pacientes que hayan recibido al menos 1 infusion de HepaStem serán invitados a participar en el Registro de Seguimiento de Pacientes a largo plazo, PROLONGSTEM.
    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 Decision2020-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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