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    Summary
    EudraCT Number:2022-002653-26
    Sponsor's Protocol Code Number:PULMESCELL-2
    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:2023-01-16
    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 number2022-002653-26
    A.3Full title of the trial
    PHASE II CLINICAL TRIAL TO ESTABLISH THE SAFETY OF THE USE OF EXPANDED ALLOGENEIC FETAL UMBILICAL CORD STEM MESENCHYMAL CELLS IN PRETERM PATIENTS WITH BRONCHOPULMONARY DYSPLASIA
    ENSAYO CLÍNICO FASE II PARA ESTABLECER LA SEGURIDAD DEL USO DE CÉLULAS MESENQUIMALES TRONCALES FETALES ALOGÉNICAS DE CORDÓN UMBILICAL EXPANDIDAS EN PACIENTES PREMATUROS CON DISPLASIA BRONCOPULMONAR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ESTABLISHING THE SAFETY OF THE USE OF EXPANDED ALLOGENEIC FETAL UMBILICAL CORD STEM MESENCHYMAL CELLS IN PRETERM PATIENTS WITH BRONCHOPULMONARY DYSPLASIA
    ENSAYO CLÍNICO FASE II PARA ESTABLECER LA SEGURIDAD DEL USO DE CÉLULAS MESENQUIMALES TRONCALES FETALES ALOGÉNICAS DE CORDÓN UMBILICAL EXPANDIDAS EN PACIENTES PREMATUROS CON DISPLASIA BRONCOPULMONAR
    A.3.2Name or abbreviated title of the trial where available
    PULMESCELL-2
    PULMESCELL-2
    A.4.1Sponsor's protocol code numberPULMESCELL-2
    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 para la Investigación Biomédica Hospital Ramón y Cajal
    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 supportProyectos de Investigación Clínica Independiente otorgada por el Instituto de Salud Carlos III (ICI19/00092).
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomedica Hospital Ramón y Cajal
    B.5.2Functional name of contact pointDra. María Jesús del Cerro
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Colmenar Km 9.100
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.4Telephone number++34913368825
    B.5.5Fax number++34913368825
    B.5.6E-mailmjesus.cerro@salud.madrid.org
    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 namecelulas mesenquimales troncales fetales alogenicas de cordon umbilical expandidas
    D.3.2Product code celulas mesenquimales troncales fetales alogenicas
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNcelulas mesenquimales alogenicas derivadas de cordon umbilical
    D.3.9.3Other descriptive nameMESENCHYMAL CELLS
    D.3.9.4EV Substance CodeSUB181188
    D.3.10 Strength
    D.3.10.1Concentration unit millilitre(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Live newborns weighing ≤ 1250 grams and gestational age ≤ 28 weeks, who are on mechanical ventilation with a FiO2 ≥ 0.3 between days 5 and 14 of life, with no immediate extubation foreseeable
    Recién nacidos vivos con un peso ≤ 1250 gramos y edad gestacional ≤ 28 semanas, que seencuentren en ventilación mecánica con una FiO2 ≥ 0.3 entre los días 5 y 14 de vida, sin que sea previsible su extubación de forma inmediata.
    E.1.1.1Medical condition in easily understood language
    Pacientes prematuros con displasia broncopulmonar.
    Premature patients with bronchopulmonary dysplasia.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10006475
    E.1.2Term Bronchopulmonary dysplasia
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and feasibility of repeated intravenous infusions of UC-MSC 5x106 cells/kg in preterm patients ≤ 28 weeks gestational age and ≤ 1250 g weight.
    Evaluar la seguridad y la factibilidad de infusiones intravenosas repetidas de UC-MSC 5x106 células /kg en pacientes prematuros ≤ 28 semanas de edad gestacional y ≤ 1250 g de peso.
    E.2.2Secondary objectives of the trial
    To observe the incidence of severe BPD or death at 36W postmenstrual age.
    To observe the incidence of death at 36 and 40W postmenstrual age and at discharge.
    To observe the incidence of complications of prematurity.
    To investigate changes in markers of inflammation, oxidative stress and lung damage.
    To analyze the variations in echocardiographic parameters of pulmonary hypertension before and after.
    Variation in the modified respiratory status score and RSS score during therapy and up to W36 of EPM.
    To observe the need for supplemental O2 at home discharge and at 18 months and the duration of both invasive and noninvasive mechanical ventilation.
    Evaluate the use of postnatal corticosteroids as treatment or prevention of BPD.
    To analyze the rate of readmissions in the first year due to respiratory causes.
    To evaluate the Bayley developmental scale of infants and toddlers at 24 months of age.
    To compare safety, feasibility and explore efficacy
    Observar la incidencia de DBP grave o de muerte a los 36S de edad postmenstrual.
    Observar la incidencia de muerte a los 36 y 40S de edad postmenstrual y al alta.
    Observar la incidencia de complicaciones de la prematuridad.
    Investigar los cambios en los marcadores de inflamación, estrés oxidativo y daño pulmonar.
    Analizar las variaciones ecocardiográficos de la hipertensión pulmonar antes y después.
    Variación de la puntuación del estado respiratorio modificado y de la puntuación del RSS durante la terapia y hasta la 36S de la EPM.
    Observar la necesidad de O2 suplementario al alta domiciliaria y a los 18 meses y la duración de la ventilación mecánica invasiva y no invasiva.
    Evaluar el uso de corticoides postnatales como tratamiento/prevención de la DBP.
    Analizar la tasa reingresos en el primer año por causas respiratorias.
    Evaluar la escala de desarrollo de Bayley de lactantes y niños pequeños a los 24 meses edad.
    Seguridad, la viabilidad y explorar la eficacia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Live newborns weighing ≤ 1250 grams and gestational age ≤ 28 weeks, who are on mechanical ventilation with a FiO2 ≥ 0.3 between days 5 and 14 of life, with no immediate extubation foreseeable.
    Recién nacidos vivos con un peso ≤ 1250 gramos y edad gestacional ≤ 28 semanas, que se encuentren en ventilación mecánica con una FiO2 ≥ 0.3 entre los días 5 y 14 de vida, sin que sea previsible su extubación de forma inmediata.
    E.4Principal exclusion criteria
    Patients with other concomitant congenital pathology at the time of inclusion: pulmonary malformations with compromised pulmonary function, active pulmonary hemorrhage, severe pulmonary hypoplasia, renal malformations with systemic compromise, congenital heart disease, polymalformative syndromes, chromosomopathies.
    Patients presenting refractory hemodynamic instability of any cause at the time of inclusion.
    Patients with severe neurological damage at the time of inclusion (HIV grade III or higher).
    Patients who have required major surgery in the 72 hours prior to inclusion.
    Patients presenting necrotizing enterocolitis (NEC) grades ≥II at the time of inclusion, according to the Bell classification.
    Patients who are children of a mother with HIV.
    Pacientes que tengan otra patología congénita concomitante en el momento de inclusión: malformaciones pulmonares con compromiso de la función pulmonar, hemorragia pulmonar activa, hipoplasia pulmonar severa, malformaciones renales con compromiso sistémico, cardiopatía congénita, síndromes polimalformativos, cromosomopatías.
    Pacientes que presenten inestabilidad hemodinámica refractaria de cualquier causa en el momento de inclusión.
    Pacientes que presenten lesión neurológica grave en el momento de inclusión (HIV grado III o mayor).
    Pacientes que hayan precisado cirugía mayor en las 72 horas previas a la inclusión.
    Pacientes que presenten enterocolitis necrotizante (NEC) grados ≥II en el momento de inclusión, según la clasificación de Bell.
    Pacientes que sean hijos de madre con VIH.
    E.5 End points
    E.5.1Primary end point(s)
    Safety assessment: adverse reactions (AR)
    Evaluación de la seguridad: reacciones adversas (RA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the administration of the first dose until 2 years of age.
    Desde la administración de la primera dosis hasta los 2 años de edad.
    E.5.2Secondary end point(s)
    Status at week 36 of EPM (death/DBP grade 3).
    Diagnosis and stage of BPD at 36 weeks' EPM according to Jensen's classification (no BPD/grade 1/grade 2/grade 3).
    Exitus at 36 and 40 weeks of EPM or at discharge (yes/no).
    Incidence of comorbidities derived from prematurity Variations in the levels of biomarkers of inflammation, oxidative stress and lung damage with respect to baseline.
    Variations in echocardiographic parameters of pulmonary hypertension before and after .
    Variation in the modified respiratory score and RSS score during therapy and up to week 36 of EPM.
    Date of hospital discharge and respiratory care at discharge.
    Need for supplemental O2 at home discharge and during follow-up.
    Duration of invasive and non-invasive mechanical ventilation.
    Use of postnatal corticosteroids indicated for treatment or prevention of BPD.
    Respiratory readmission rate.
    Bayley Neurodevelopmental Scale at 24 months.
    Exit date and cause.
    Estado en la semana 36 de EPM (muerte/DBP grado 3).
    Diagnóstico y estadío de DBP en la semana 36 de EPM según la clasificación de Jensen (no DBP/grado 1/grado 2/grado 3).
    Éxitus en las semanas 36 y 40 de EPM o al alta (sí/no).
    Incidencia de comorbilidades derivadas de la prematuridad Variaciones en los niveles de biomarcadores de inflamación, estrés oxidativo y daño pulmonar respecto al basal.
    Variaciones en los parámetros ecocardiográficos de hipertensión pulmonar antes y después .
    Variación en el score respiratorio modificado y en el RSS score durante la terapia y hasta la semana 36 de EPM.
    Fecha de alta hospitalaria y asistencia respiratoria al alta.
    Necesidad de O2 suplementario al alta domiciliaria y durante el seguimiento.
    Duración de la ventilación mecánica invasiva y no invasiva.
    Uso de corticoides postnatales indicados para tratamiento o prevención de DBP.
    Tasa de reingresos de causa respiratoria.
    Escala de neurodesarrollo de Bayley a los 24 meses.
    Fecha de éxitus y causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From signature of informed consent until 2 years of age.
    Desde firma del consentimiento informado hasta los 2 años de edad.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Práctica clínica habitual
    Standard of care
    E.8.2.4Number of treatment arms in the trial3
    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 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
    El estudio finalizará cuando el último paciente reclutado realice la última visita de seguimiento.
    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 months6
    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 Yes
    F.1.1Number of subjects for this age range: 75
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 75
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 75
    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) No
    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 No
    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
    The patients are premature newborns so informed consent will be given by their parents or guardians.
    Los pacientes son recién nacidos prematuros por lo que el consentimiento informado será otorgado por sus padres o tutores.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    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)
    Once the treatment is completed (standard treatment, 3 doses of mesenchymal cells or 6 doses of mesenchymal cells) patients will undergo a clinical follow-up only. This follow-up corresponds to the usual one, with no additional visits being necessary. The follow-up variables will be collected during these visits.
    Una vez finalizado el tratamiento ( tratamiento estandar, 3 dosis de celulas mesenquimales o 6 dosis de celulas mesenquimales) los pacientes se someterán exclusivamente a un seguimiento clínico. Este seguimiento corresponde al habitual, no siendo necesarias visitas adicionales. Las variables de seguimiento se recogerán en esta visitas.
    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 Decision2023-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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