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    Summary
    EudraCT Number:2014-003108-56
    Sponsor's Protocol Code Number:PULMESCEL-1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-29
    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 number2014-003108-56
    A.3Full title of the trial
    Clinical Trial: Feaseability and security of the treatment of Bronchopulmonary Dysplasia in preterm babies with expanded umbilical cord allogenic fetal mesenchymal stem cells.
    Ensayo Clínico Fase I 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
    Feaseability and security of the treatment of pulmonary disease in preterm babies with Mesenchymal Stem Cell Therapy.
    Ensayo clínico para establecer la seguridad del uso de células madre indiferenciadas en pacientes prematuros con enfermedad pulmonar.
    A.3.2Name or abbreviated title of the trial where available
    Security of the treatment of pulmonary disease in preterm babies with Mesenchymal Stem Cell Therapy
    Seguridad del uso de células mesenquimales en pacientes prematuros con displasia broncopulmonar.
    A.4.1Sponsor's protocol code numberPULMESCEL-1
    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 del 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 supportFundación contra la Hipertensión Pulmonar
    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 biomédica del Hospital Ramón y Cajal.
    B.5.2Functional name of contact pointDra. Álvarez Fuente
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Colmenar Viejo Km 9.100
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.4Telephone number+34649680961
    B.5.6E-mailm.alvarez.fuente@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 nameCélulas mesenquimales troncales fetales alogenicas de cordón umbilical expandidas
    D.3.2Product code Células 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 INNCélulas mesenquimales troncales fetales alogenicas de cordón umbilical expandidas
    D.3.9.3Other descriptive nameCélulas Mesenquimales
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    10 preterm babies under 28 weeks of gestational age and under 1250 grams of weight, at high risk of presenting pulmonary damage.
    10 recién nacidos pretérmino con un peso menor o igual a 1250 gramos y EG menor de 28 semanas, con alto riesgo de displasia broncopulmonar.
    E.1.1.1Medical condition in easily understood language
    Preterm babies admitted in the neonatology intensive care unit, at high risk of developing bronchopulmonary displasia.
    Recién nacidos prematuros ingresados en la unidad de cuidados intensivos neonatales con alto riesgo de desarrollar displasia broncopulmonar.
    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 20.0
    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
    Evaluate the feasebility and security of mesenchymal stem cell therapy in preterm very low weight babies with high risk of developing bronchopulmonary dysplasia.
    Evaluar la factibilidad y seguridad de la terapia con células mesenquimales en los recién nacidos pretérmino de muy bajo peso con alto riesgo de DBP.
    E.2.2Secondary objectives of the trial
    1. Analysis of the changes of the inflammatory biomarkers after the administration of mesenchymal stem cell therapy.
    2. Analysis of the variations of echocardiographic parameters related with the therapy.
    3. Evaluation of the incidence of severe bronchopulmonary dysplasia and pulmonary hypertension y the group of treated patients.
    1.Investigar los cambios en los marcadores de inflamación y daño pulmonar en relación con la administración de células mesenquimales.
    2. Analizar las variaciones en los parámetros ecocardiográficos de hipertensión pulmonar antes y después de la terapia con células mesenquimales.
    3. Evaluar la incidencia de DBP grave y de HTP en el grupo de pacientes tratados.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Preterm newborns with a weight under or equal to 1250 gr and under 28 gestational age weeks, born between October 2017 and October 2018, that are candidates for corticoid therapy:
    - On mechanical ventilation with oxigen fraction of at least 0.3 con day 14th of life.
    - No prevision of extubation.
    Patients will be recluted in three different hospitals: Hospital La Paz, Hospital de Getafe, Hospital Clínico San Carlos and Hospital Puerta de Hierro.
    Recién nacidos vivos con un peso menor o igual a 1250 gramos y EG menor de 28 semanas, que nazcan en un periodo de un año entre octubre de 2017 y octubre de 2018, que sean potenciales candidatos a recibir tratamiento corticoideo en el contexto de un algo riesgo de DBP. Es decir, que a los 14 días de vida se mantienen con ventilación mecánica con una FiO2 mayo o igual a 0,3 y que no sea previsible su extubación de forma inmediata. Los pacientes serán reclutados en los siguientes hospitales de la Comunidad de Madrid: Hospital Universitario La Paz, Hospital Universitario de Getafe, Hospital Clínico San Carlos y Hospital Universitario Puerta de Hierro/Majadahonda.
    E.4Principal exclusion criteria
    - Congenital malformation at the moment of inclusion: pulmonary malformations with decreased pulmonary function, pulmonary active bleeding, severe pulmonary hypoplasia, renal malformations with systemic afection, congenital heart disease, malformative syndromes, chromosomopathy.
    - Patients without a written consent.
    - Hemodynamic alterations at inclusio time.
    - Major surgery in the 72 previous hours before inclusion.
    - Necrotizing enterocolitis grades II or higher at inclusio time.
    - HIV infected mother.
    - Que tenga 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.
    - Que no tengan el consentimiento por escrito de sus padres o tutores.
    - Inestabilidad hemodinámica refractaria (de cualquier causa) en el momento de inclusión.
    - Lesión neurológica grave en el momento de inclusión (HIV grado III o mayor).
    - Cirugía mayor en las 72 horas previas a la inclusión.
    - Enterocilitis necrotizante (NEC) grados II o > en el momento de inclusión.
    - Hijos de madre VIH.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the security of the therapy with mesenchymal stem cells in these patients.
    Evaluación de la seguridad de la terapia con células mesenquimales en estos pacientes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the last doses the immediate effects will be evaluated.
    Se evaluarán los efectos inmediatos al finaluzar la última dosis.
    E.5.2Secondary end point(s)
    Evaluation of the pulmonary development of these patients and the incidence of bronchopulmonary dysplasia.
    Evaluación del desarrollo pulmonar en estos pacientes y cálculo de la incidencia de displasia broncopulmonar.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These patients will be followed-up for 5 years, in order to evaluate the pulmonary system and the possible late adverse effects.
    Estos pacientes permanecerán en seguimiento durante 5 años para evaluar el desarrollo pulmonar y los posibles efectos adversos a largo plazo.
    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) 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) No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Controles históricos y práctica habitual.
    Historical controls.
    E.8.2.4Number of treatment arms in the trial1
    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 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 del seguimiento.
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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: 10
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 10
    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 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
    The patients are preterm newborns. The consent must be given by the parents or tutors.
    Los pacientes son recién nacidos prematuros, por lo que el consetimiento 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 state10
    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)
    After the treatment (3 doses of mesenchymal stem cells) the patients will only have a clinical follow-up. During the follow-up the patients will attend the regular visits considered necesary for these patients, no extraordinary visits will be required. The follow-up information will be achieved in these visits.
    Una vez finalizado el tratamiento (3 dosis de células mesenquimales), los pacientes se someterán exclusivamente a un seguimiento clínico. Este seguimiento corresponde al habitual en estos pacientes, no siendo necesario hacer visitas extraordinarias por participar en el estudio. Las variables del seguimiento se recogerán en estas 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 Decision2018-02-09
    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 StatusCompleted
    P.Date of the global end of the trial2022-07-07
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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