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    Summary
    EudraCT Number:2020-001266-11
    Sponsor's Protocol Code Number:BALMYS-19
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-16
    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 number2020-001266-11
    A.3Full title of the trial
    Two-center, randomized, controlled clinical trial with two treatment arms to evaluate the safety and efficacy of intravenous administration of expanded allogeneic adipose tissue adult mesenchymal cells in critically ill patients COVID-19.
    Ensayo clínico multicéntrico, aleatorizado, controlado, con dos ramas de tratamiento para evaluar la seguridad y eficacia de la administración intravenosa de células mesenquimales troncales adultas alogénicas de tejido adiposo y expandidas, en pacientes críticos COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of administration of MSC to patients with respiratory distress type COVID-19
    Ensayo clínico de administración de MSC a pacientes con distrés respiratorio tipo COVID-19
    A.4.1Sponsor's protocol code numberBALMYS-19
    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 SponsorFundación Instituto de Investigación Sanitaria Fundación Jiménez Diaz
    B.1.3.4CountrySpain
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Instituto de Investigación Sanitaria Fundación Jiménez Díaz
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Reyes Catolicos 2
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number0034915 50 48 003214
    B.5.6E-mailmireia.arcas@fjd.es
    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 nameAllogeneic mesenchymal stromal cells isolated from adipose tissue
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllogeneic adipose-derived mesenchymal stromal cells in vitro expanded
    D.3.9.3Other descriptive nameAllogeneic adipose-derived mesenchymal stem cells in vitro expanded
    D.3.9.4EV Substance CodeSUB199811
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.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
    Respiratory distress secondary to SARS-Cov-2 infection
    Distrés respiratorio secundario a infección por SARS-Cov-2.
    E.1.1.1Medical condition in easily understood language
    Respiratory distress secondary to SARS-Cov-2 infection
    Distrés respiratorio secundario a infección por SARS-Cov-2
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    The main objective of this project is to evaluate the efficacy of the administration of expanded allogeneic adipose tissue mesenchymal stem cells, in patients infected with SARS-COV-2 with complications like COVID-19.
    El objetivo principal de este proyecto es evaluar la eficacia de la administración de células troncales mesenquimales derivadas de tejido adiposo y expandidas, en pacientes infectados por SARS-Cov-2 con complicaciones tipo COVID-19.
    E.2.2Secondary objectives of the trial
    -To evaluate the safety of the administration of expanded allogeneic adipose tissue mesenchymal stem cells, in patients infected with SARS-COV-2 with complications like COVID-19.
    -To evaluate preclincial variables
    -Evaluar la seguridad de la administración de células troncales mesenquimales derivadas de tejido adiposo y expandaidas, en pacientes infectados por SARS-CoV-2 con complicaciones tipo COVID.
    -Evaluar variables preclínicas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients of both sexes.
    -Over 18 years.
    -Confirmation of SARS-COV-2 infection by RT-PCR in respiratory sample.
    -Respiratory failure requiring intubation and connection to mechanical ventilation, secondary to SARS-CoV-2 infection.
    -Criteria for acute respiratory distress: acute bilateral alveolar-interstitial infiltrate not compatible with left ventricular failure (demonstrated with ultrasound or hemodynamic parameters), sudden onset, and blood gas compromise with a PaO2 / FiO2 ratio <200 mm-Hg.
    -Women of childbearing potential should have a negative urine pregnancy test performed at the time of study enrollment.
    -Written or verbal informed consent from the patient or the legal representative.
    -Pacientes de ambos sexos
    -Mayores de 18 años
    -Confirmación de infección por SARS-COV-2 mediante RT-PCR en una muestra respiratoria
    -Fallo respiratorio que requiera intubación y conexión a ventilación mecánica, secundario a infección por SARS-Cov-2.
    -Criterios de distrés respiratorio agudo: infiltrado agudo alveolo-intersticial no compatible con fallo de ventrículo izquierdo (demostrado con ecografía y parámetros hemodinámicos), de inicio súbito, y compromiso gaseoso con ratio PaO2/FiO2<200 mmHg.
    -Mujeres en edad fértil deben tener prueba de embarazo en orina negativa realizada en el momento de inclusión en el estudio.
    -Consentimiento informado escrito o verbal por parte del paciente o del representante legal.
    E.4Principal exclusion criteria
    -Any other cause of acute respiratory distress not attributable to SARS-Cov-2.
    -RT-PCR of SARS-Cov-2 negative.
    Mult Multi-organ failure (more than three organs)
    -Severe respiratory failure requiring extracorporeal support (ECMO)
    -Moderate- severe COPD requiring chronic home oxygen therapy.
    -Pregnancy, lactation and women of childbearing age but who do not take effective contraceptive measures.
    -Active tumor disease.
    -Previous immunosuppressive treatment.
    -Allergy or hypersensitivity to the administered products.
    -History of deep vein thrombosis or pulmonary embolism in the last 3 years.
    -Participation in other clinical trials during the 3 months prior to the initial visit.
    -Cualquier otra causa de distrés respiratorio agudo que no sea atribuible a SARS-Cov-2.
    -RT-PCR para SARS-Cov-2 negativa.
    -Fallo multiorgánico (más de 3 órganos).
    -Fallo respiratorio severo que requiera soporte extracorpóreo (ECMO).
    -EPOC moderado-severo que requiera oxigenoterapia crónica domiciliaria.
    -Embarazo, lactancia, o mujeres que no edad fértil que no tomen medidas contraconceptivas eficaces.
    -Enfermedad tumoral activa.
    -Tratamiento inmunosupresor previo.
    -Alergia o hipersensibilidad a los productos administrados.
    -Historia de trombosis venosa o pulmonar en los últimos 3 años.
    -Participación en otros ensayos clínicos durante los 3 meses previos a la visita de inicio.
    E.5 End points
    E.5.1Primary end point(s)
    % survival at 28 days after treatment
     Days from the patient enters the study until the temperature normalizes: measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month.
    o Normalization of the temperature defined as: reaching a body temperature between 35ºC and 37ºC
     Days until patient was extuted: defined as
    (Total days with mechanical ventilation) - (Total days without mechanical ventilation) Measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month.
     Number of patients who abandoned mechanical ventilation, defined as: (Total of patients with mechanical ventilation at the time of inclusion) - (Total of patients who abandoned mechanical ventilation)
    Measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month.
     Number of patients that go from Mechanical Ventilation to oxygen therapy: measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month.
     Duration of oxygen therapy (days), defined as: (Total days in the study) - (Total days of need for oxygen therapy). Measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month.
     Days of stay in the Intensive Care Unit: defined as (Total days in the study) - (Total days in the Intensive Care Unit).
     Duration of hospitalization (days): defined as (Total days in the study) - (Total days hospitalized)
     Oxygen saturation: measurement on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month
    Pa PaO2 / FiO2 ratio: measurement on Day 1, Day 3, Day 7, Day 10, 3rd month, and 6th month.
    Radi Radiological pattern on Chest Radiography: decrease in interstitial alveolar infiltrates: yes / no. Measurement on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month.
    FA SOFA score: measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month.
     Murray score: measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month
     Analytical parameters: measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month
    o Hties, Hb, Hto, VCM, Leukocytes with leukocyte formula, platelets. procalcitonin
    o Glucose, Glycosylated Hb, urea, uric acid, creatinine, total bilirubin, direct bilirubin, sodium, potassium, calcium, chlorine, total protein, C-reactive protein, AST, ALT, GGT, Cl Cr and FG.
    o Coagulation: prothrombin time (TP), activated partial thromboplastin time (APTT), thrombin time (TT), Fibrinogen, INR.
    o IL-6, IL-2, DD, lactate dehydrogenase, CK (Creatin Kinase), Alkaline Phosphatase
    o Lymphocyte population: CD4 +, CD8 + T lymphocytes, B lymphocytes, NK cells
    or C3, C4, IgG, IgA, IgM.
     % de supervivencia a los 28 días posteriores al tratamiento
     Días desde que el paciente entra en el estudio hasta que se normaliza la temperatura: medido en Día 1, Día 3, Día 7, Día 10, 3º mes y 6º mes.
    o Normalización de la temperatura definida como: alcanzar una temperatura corporal entre 35ºC y 37ºC
     Días hasta que se extuba el paciente: definido como
    (Total de días con ventilación mecánica) – (Total de días libre de ventilación mecánica)Medido en Día 1, Día 3, Día 7, Día 10, 3º mes y 6º mes.
     Número de pacientes que abandona la ventilación mecánica, definido como: (Total de pacientes con ventilación mecánica en el momento de la inclusión) – (Total de pacientes que abandona la ventilación mecánica)
    Medido en Día 1, Día 3, Día 7, Día 10, 3º mes y 6º mes.
     Número de pacientes que pasan de Ventilación Mecánica a oxigenoterapia: medido en Día 1, Día 3, Día 7, Día 10, 3º mes y 6º mes.
     Duración de la oxigenoterapia (días), definido como: (Total de días en el estudio)-(Total de días de necesidad de oxigenoterapia). Medido en Día 1, Día 3, Día 7, Día 10, 3º mes y 6º mes.
     Días de estancia en la Unidad de Cuidados Intensivos: definido como (Total de días en el estudio) – (Total de días en la Unidad de Cuidados Intensivos).
     Duración de la hospitalización (días): definido como (Total de días en el estudio) – (Total de días hospitalizado)
     Saturación de oxígeno: medición en Día 1, Día 3, Día 7, Día 10, 3º mes y 6º mes
     Ratio PaO2/FiO2: medición en Día 1, Día 3, Día 7, Día 10, 3º mes, y 6º mes.
     Patrón radiológico en Radiografía de Tórax: disminución de infiltrados alveolo intersticiales: sí/no. Medición en Día 1, Día 3, Día 7, Día 10, 3º mes y 6º mes.
     SOFA score: medido en Día 1, Día 3, Día 7, Día 10, 3º mes y 6º mes.
     Murray score: medido en Día 1, Día 3, Día 7, Día 10, 3º mes y 6º mes
     Parámetros analíticos: medido en Día 1, Día 3, Día 7, Día 10, 3º mes y 6º mes
    o Hties, Hb, Hto, VCM, Leucocitos con fórmula leucocitaria, plaquetas. procalcitonina
    o Glucosa, Hb Glicosilada, urea, ácido úrico, creatinina, bilirrubina total, bilirrubina directa, sodio, potasio, calcio, cloro, proteínas totales, proteína C reactiva, AST, ALT, GGT, Cl Cr y FG.
    o Coagulación: tiempo de protrombina (TP), tiempo de tromboplastina parcial activada (TTPA), tiempo de trombina (TT), Fibrinógeno, INR.
    o IL-6, IL-2, DD, lactato deshidrogenasa, CK (Creatin Kinasa), Fosfatasa Alcalina
    o Población linfocitaria: linfocitos T CD4+, CD8+, Linfocitos B, Células NK
    o C3, C4, IgG, IgA, IgM.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, Day 3, Day 7, day 10, Third Month, Sixth Month
    Día 1, Día 3, Día 7, Día 10, Tercer mes, Sexto mes.
    E.5.2Secondary end point(s)
    Preclinical variables
     Immune functions
    o T lymphocyte count
    o Count of CD4 + T lymphocytes, CD8 + T lymphocytes and B lymphocytes (flow cytometry)
    o Alanine aminotransferase
     Analytics
    o Blood concentration of IL-1β, IL-2R, IL-4 IL-6, IL-8, IL-10, TNF-α, IFNγ, TGFβ
    o Pro-Peptide B natriuretic (pro-BNP)

    Safety variables
    % and type of complications derived from treatment.
    o Complications during the application of the treatment (Day 1)
    o Complications on Day 3, Day 7, Day 10, Day 28, 3rd month and 6th month.
    Variables preclínicas
     Funciones inmunológicas
    o Contaje de linfocitos T
    o Contaje de linfocitos T CD4+ , linfocitos T CD8+ y linfocitos B (citometría de flujo)
    o Alanino aminotranferasa
     Analítica
    o Concentración en sangre de IL-1β, IL-2R, IL-4 IL-6, IL-8,IL-10,TNF-α, IFNγ, TGFβ
    o Pro-Péptido B natriurético (pro-BNP)

    Variables de seguridad
     % y tipo de complicaciones derivadas del tratamiento.
    o Complicaciones durante la aplicación del tratamiento (Día 1)
    o Complicaciones en el Día 3, Día 7, Día 10, Día 28, 3º mes y 6º mes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Day 3, Day 7, Day 10, Third Month, Sixth Month
    Día 1, Día 3, Día 7, Día 10, Tercer Mes, Sexto Mes
    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 No
    E.8.1.3Single blind Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned6
    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
    Last patient last visit
    último paciente última visita
    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 months8
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients will be intubated, so informed consent will be requested from family members or legal representatives and if the patient evolves favorably, they will ratify the informed consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    If the results are favorable, the next phase of the trial will be designed and executed so that the treatment reaches more patients
    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 Decision2020-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-11-11
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