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    Summary
    EudraCT Number:2017-004123-67
    Sponsor's Protocol Code Number:PHRCI2012/CHOCMSC-GIBOT/SKJ
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-004123-67
    A.3Full title of the trial
    CHOCMSC Study
    Effects of mesenchymal stem cells administration on organ failure during septic shock: Phase II randomized placebo-controlled study
    Etude CHOCMSC
    Effets de l’administration de cellules souches mésenchymateuses sur la défaillance d’organes au cours du choc septique : Etude de phase II randomisée versus placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of severe infections with mesenchymal stem cells
    Traitement par cellules souches mésenchymateuses des infections sévères
    A.3.2Name or abbreviated title of the trial where available
    CHOCMSC Study
    Etude CHOCMSC
    A.4.1Sponsor's protocol code numberPHRCI2012/CHOCMSC-GIBOT/SKJ
    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 SponsorCentre Hospitalier Régional Universitaire de Nancy
    B.1.3.4CountryFrance
    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 supportCHRU de Nancy
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDirection de la Recherche et de l'Innovation
    B.5.2Functional name of contact pointChef de projet
    B.5.3 Address:
    B.5.3.1Street AddressHôpitaux de Brabois-Rue du Morvan
    B.5.3.2Town/ cityVANDOEUVRE LES NANCY
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.4Telephone number0033 383155277
    B.5.5Fax number0033 383157451
    B.5.6E-maildripromoteur@chru-nancy.fr
    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 nameMesenchymal Stem Cells (MSCs)
    D.3.2Product code CSM-MO
    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 INNMesenchymal stem cells derived from allogeneic bone marrow
    D.3.9.3Other descriptive nameMesenchymal stem cells derived from allogeneic bone marrow
    D.3.9.4EV Substance CodeSUB176600
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000
    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) 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name VIALEBEX 40 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderLfb-Biomedicaments
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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 injection
    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
    septic shock
    Choc septique
    E.1.1.1Medical condition in easily understood language
    severe infection
    Infection sévère
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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 determine the effect of mesenchymal stem cells (MSCs) administered at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group.
    Déterminer l’effet de cellules souches mésenchymateuses (CSMs) administrées à la phase précoce du choc septique sur l’évolution des défaillances d’organes jugée par le score SOFA (Sepsis Organ Failure Assessment score) à J7 (ou bien le jour du décès ou de la sortie de réanimation si avant J7) par rapport à celui observé chez les patients du groupe contrôle.
    E.2.2Secondary objectives of the trial
    1- To appreciate the role of the MSCs on the occurrence and duration of organ failure individually
    2- To appreciate the effect MSCs on mortality judged at Day 28 and Day 90, the length of stay in intensive care unit
    3-To study the immediate tolerance profile and at 3 months of an injection of allogeneic bone marrow CSMs at a dose of 1.106 / kg.
    1- Apprécier le rôle des CSMs sur la survenue et la durée des défaillances d’organes prises individuellement
    2- Apprécier le rôle des CSMs sur la mortalité jugée à J28 et à J90, la durée de séjour en réanimation
    3-Etudier le profil de tolérance immédiate et à 3 mois d’une injection de CSMs allogéniques de Moelle osseuse à la dose de 1.106/kg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1-Male Patient 18 years of age or older, or Woman over 65 years
    2-Presence of community-acquired septic shock for less than 12 hours and associated with at least 2 organ failure other than cardiovascular. The time of septic shock onset is defined as the time of catecholamines introduction
    3-Septic shock occurring between Monday 8:00 am and Friday 8:00 am (for reasons of availability of the staff of the UTCT)
    4-Prior receipt of written consent (patient / trusted person / family member)
    5-Person affiliated to a Social Security
    1-Patient Homme âgé de 18 ans ou plus, ou Femme âgée de plus de 65 ans
    2-Présence d’un choc septique d’origine communautaire depuis moins de 12 heures. L’heure de début du choc septique est définie comme l’heure d’introduction des catécholamines Avec au moins 2 défaillances d’organe autres qu’hémodynamiques
    3-choc septique survenant entre le Lundi 8 heures et le Vendredi 8 heures (pour des raisons de disponibilité des personnels de l’UTCT)
    4-Obtention préalable du consentement écrit (patient/ personne de confiance / membre de la famille)
    5-Personne affiliée à un régime de Sécurité Sociale ou bénéficiaire d’un tel régime.
    E.4Principal exclusion criteria
    1-Shock of non-septic origin
    2-Nosocomial septic shock
    3-PaO2 / FiO2 ratio <100
    4-Female under 65 years
    5-brain death
    6-Moribund patient
    7-Initial limatation of care or DNR orders
    8-Patient already enrolled in another interventional tria, ongoing or for less than 30 days
    1- Choc d’origine non septique
    2- Choc septique nosocomial
    3- Ratio PaO2/FiO2 < 100
    4-Femme de moins de 65 ans
    5-Etat de mort encéphalique
    6-Patient moribond
    7-Existence de limitations thérapeutiques d’emblée
    8-Patient inclus dans un autre essai thérapeutique interventionnel en cours ou depuis moins de 30 jours
    E.5 End points
    E.5.1Primary end point(s)
    to determine the effect of mesenchymal stem cells (MSCs) administered at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group.
    Le critère d’évaluation principal est le score SOFA (score clinico-biologique de sévérité variant de 0 à 24 points) à J7 (ou bien le jour du décès ou de la sortie de réanimation si avant J7) comparé à celui observé chez les patients du groupe contrôle.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7)
    Jour 7 (ou le jour du décès ou de la sortie de réanimation si avant J7)
    E.5.2Secondary end point(s)
    Secondary end point 1
    i) the number of days alive without respiratory support on Day 28,
    (ii) the number of days alive without catecholamines on Day 28,
    (iii) the number of days alive without renal suppot at Day 28,
    (iv) the length of stay in the intensive care unit and in the hospital,
    Secondary end point 2
    i) the mortality at Day 28,
    ii) the mortality at Day 90
    Secondary end point 3
    i) Transient decrease in PaO2 / FiO2 ratio (or arterial desaturation> 5%) within 2 hours of CSMs administration
    ii) Transient elevation of mean pulmonary arterial pressure (> 5 mHg) within 2 hours of CSMs administration
    iii) Chills, hyperthermia within 2 hours of CSMs administration
    iv) Occurrence of pulmonary embolism within 2 hours after CSMs administration
    v) Occurrence of side effects up to 90 days after MSC injection.
    Objectif secondaire 1
    i) le nombre de jours vivant sans assistance respiratoire à J28,
    ii) le nombre de jours vivant sans catécholamines à J28,
    iii) le nombre de jours vivant sans épuration extra-rénale à J28,
    iv) la durée de séjour en réanimation et à l’hôpital,
    Objectif secondaire 2
    i) la mortalité à J28,
    ii) la mortalité à J90
    Objectif secondaire 3
    i) Baisse transitoire du rapport PaO2/FiO2 (ou désaturation artérielle >5%) dans les 2 heures suivant l’administration des CSM
    ii) Elévation transitoire de la pression artérielle pulmonaire moyenne (>5 mHg) dans les 2 heures suivant l’administration des CSM
    iii) Frissons, hyperthermie dans les 2 heures suivant l’administration des CSM
    iv) Survenue d’une embolie pulmonaire dans les 2 heures suivant l’administration des CSM
    v) Survenue d’effets indésirables jusqu’à 90 jours après l’injection des CSM.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end point 1: Day 28
    Secondary end point 2: Day 28 and Day 90
    Secondary end point 3: within 2 hours after CSMs administration and within 3 months after CSMs administration
    Objectif secondaire 1: J28

    Objectif secondaire 2: J28 et J90

    Objectif secondaire 3:
    dans les 2 heures suivant l’administration des CSM et dans les 3 mois suivant l’administration des CSM
    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 No
    E.6.5Efficacy No
    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 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 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 concerned3
    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: Day 90
    Dernière visite du dernier patient : J90
    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 months42
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 No
    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
    Presence of community-acquired septic shock for less than 12 hours and associated with at least 2 organ failure other than cardiovascular
    Présence d’un choc septique d’origine communautaire depuis moins de 12 heures avec au moins 2 défaillances d’organe autres qu’hémodynamiques
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    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)
    NONE
    AUCUN
    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 Decision2021-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-07
    P. End of Trial
    P.End of Trial StatusOngoing
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