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    The EU Clinical Trials Register currently displays   38177   clinical trials with a EudraCT protocol, of which   6271   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-002688-89
    Sponsor's Protocol Code Number:ALICELL-CT-01
    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:2019-07-26
    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 number2019-002688-89
    A.3Full title of the trial
    Phase 1/2 clinical study to assess the feasibility, safety, tolerability and preliminary efficacy of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome. (included patients COVID-19)
    Estudio clínico de Fase 1/2 para valorar la viabilidad, seguridad, tolerabilidad y eficacia preliminar de la administración de HCR040, un medicamento cuyo principio activo es HC016, células mesenquimales troncales adultas alogénicas de tejido adiposo expandidas y pulsadas con H2O2, en pacientes con síndrome de distrés respiratorio agudo (SDRA), incluidos pacientes COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to assess the safety and preliminary efficacy of HCR040, a drug based on mesenchymal stem cells, in patients with acute respiratory distress syndrome. (included patients COVID-19)
    Estudio clínico para valorar la seguridad y eficacia preliminar de la administración de células madre mesenquimales en pacientes con síndrome de distrés respiratorio agudo, incluidos pacientes COVID-19
    A.4.1Sponsor's protocol code numberALICELL-CT-01
    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 SponsorHistocell S.L.
    B.1.3.4CountrySpain
    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 supportHistocell S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHistocell S.L.
    B.5.2Functional name of contact pointBegoña Castro
    B.5.3 Address:
    B.5.3.1Street AddressParque Tecnológico de Bizkaia, 801A, 2ª planta
    B.5.3.2Town/ cityDerio (Bizkaia)
    B.5.3.3Post code48160
    B.5.3.4CountrySpain
    B.5.4Telephone number0034946567900
    B.5.6E-mailbcastro@histocell.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 nameHCR040
    D.3.2Product code HCR040
    D.3.4Pharmaceutical form Suspension for injection
    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 INNHCR040
    D.3.9.2Current sponsor codeHCR040
    D.3.9.3Other descriptive nameALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED
    D.3.9.4EV Substance CodeSUB181445
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 2
    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 Yes
    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 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
    acute respiratory distress syndrome
    síndrome de distrés respiratorio agudo (SDRA)
    E.1.1.1Medical condition in easily understood language
    acute respiratory distress syndrome
    síndrome de distrés respiratorio agudo (SDRA).
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the feasibility, safety and tolerability of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome.
    Evaluar la viabilidad, seguridad y tolerabilidad de la administración intravenosa de HCR040, un medicamento cuyo principio activo es HC016, células mesenquimales troncales adultas alogénicas de tejido adiposo expandidas y pulsadas con H2O2, en pacientes con síndrome de distrés respiratorio agudo (SDRA).
    E.2.2Secondary objectives of the trial
    To assess the preliminary efficacy of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome.
    Evaluar la eficacia preliminar de la administración de HCR040, medicamento cuya sustancia activa es HC016, células troncales mesenquimales adultas alogénicas de tejido adiposo expandidas y pulsadas con H2O2, en pacientes con síndrome de distrés respiratorio agudo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    – Men and women ≥ 18 years
    – Patients with criteria of moderate to severe ARDS according to the Berlin Conference.
    – Patients with invasive mechanical ventilation
    - Hombres y mujeres ≥ 18 años
    - Pacientes con criterios de SDRA moderados a graves según la Conferencia de Berlín.
    - Pacientes con ventilación mecánica invasiva.
    E.4Principal exclusion criteria
    – Participation in a previous clinical study within 28 days prior to the ARDS situation.
    – Administration of a previous cell therapy product in the 5 years prior to this ARDS clinical situation.
    – Inability to obtain Informed Consent.
    • Participación en alguna investigación clínica dentro de
    los 28 días previos a la situación de SDRA .
    • Administración de un producto de terapia celular en
    los 5 años anteriores a esta situación clínica.
    • Imposibilidad de obtener el Consentimiento
    Informado.
    E.5 End points
    E.5.1Primary end point(s)
    – Adverse events
    – Average stay in the ICU
    – SOFA index
    – Mechanical ventilation
    - Acontecimientos adversos
    - Estancia media en UCI
    - Indice SOFA
    - Ventilación mecánica
    E.5.1.1Timepoint(s) of evaluation of this end point
    7, 14, 21, 28, 90, 120 and 365 post-administratión.
    7, 14, 21, 28, 90, 120 y 365días post-administración.
    E.5.2Secondary end point(s)
    – Daily pulmonary mechanics
    – Determination of lung damage
    – Days free of vasopressors
    Mecánica pulmonar diaria.
    Determinación del daño pulmonar
    Días libres de vasopresores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    7, 14, 21, 28, 90, 120 y 365 post-administration.
    7, 14, 21, 28, 90, 120 y 365 días post-administración.
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 26
    F.1.3Elderly (>=65 years) No
    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 state26
    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)
    normal treatment of that condition
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-03
    P. End of Trial
    P.End of Trial StatusOngoing
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