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    Summary
    EudraCT Number:2017-001824-23
    Sponsor's Protocol Code Number:CME-LEC1
    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:2017-09-18
    Trial results View 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 number2017-001824-23
    A.3Full title of the trial
    Intrathecal administration of autologous adult bone marrow mesenchymal stem cells expanded in the diffuse axonal injury.
    ADMINISTRACION INTRATECAL DE CELULAS MESENQUIMALES TRONCALES ADULTAS AUTOLOGAS DE MEDULA OSEA EXPANDIDAS EN EL DAÑO AXONAL DIFUSO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Administration of autologous adult bone marrow cells expanded in the diffuse axonal injury.
    ADMINISTRACION DE CELULAS ADULTAS AUTOLOGAS DE MEDULA OSEA EN EL DAÑO AXONAL DIFUSO
    A.4.1Sponsor's protocol code numberCME-LEC1
    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 de Investigación Biomédica del Hospital Universitario Puerta de Hierro-Majadahonda (FIBM-HUPHM)
    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 organisationSERMES PLANIFICACION. S.L
    B.5.2Functional name of contact pointUnidad de puesta en marcha
    B.5.3 Address:
    B.5.3.1Street AddressCalle Rufino González 14, esc. 1, 2ºD
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913756930
    B.5.5Fax number+34917542721
    B.5.6E-mailstart-up@sermescro.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 nameCélulas mesenquimales troncales adultas autólogas de medula ósea expandidas
    D.3.2Product code CME-LEC1
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcélulas mesenquimales troncales adultas autólogas de medula ósea expandidas
    D.3.9.2Current sponsor codeCME-LEC1
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000000
    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
    Traumatic cerebral injury, chronically established attributed to diffuse axonal injury.
    Lesión cerebral de causa traumática, crónicamente establecida atribuida a daño axonal difuso.
    E.1.1.1Medical condition in easily understood language
    Traumatic cerebral injury, chronically established attributed to diffuse axonal injury.
    Lesión cerebral de causa traumática, crónicamente establecida atribuida a daño axonal difuso.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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 analyze the potential clinical efficacy of intrathecal administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow mesenchymal stem cells in the treatment of a homogeneous group of patients with established chronic cerebral injury (CCI) and previous diagnosis of diffuse axonal injury.
    Analizar la posible eficacia clínica de la administración intratecal, en espacio subaracnoideo, de células mesenquimales troncales adultas autólogas de la médula ósea expandidas “in vitro” en el tratamiento de un grupo homogéneo de pacientes con lesión cerebral (LEC) crónicamente establecida y diagnóstico previo de daño axonal difuso.
    E.2.2Secondary objectives of the trial
    To confirm the treatment safety to the dose raised in the present study
    Confirmar la seguridad del tratamiento, a las dosis planteadas en el presente estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Traumatic brain injury background with cognitive effect and clinical diagnosis of diffuse axonal injury.
    2) Clinical scale studies (GCS, NIF, ASHWORTH, GOAT, DRS) as well as neurophysiology and PET-TAC that would allow to have useful baseline values, with the purpose of being able to be compared with the same examinations after the study and obtain objective data of possible efficacy.
    3) Aged between 18 and 70 years old.
    4) Possibility of follow-up evolution and neuro-rehabilitation support during the follow-up period.
    5) Written informed consent according to the current legislation.
    6) Hematologic parameters and of creatinine, SGOT and SGPT within normal range according to the laboratory standards, accepting, nonetheless, modifications that are considered not significant in the context of the treatment to be carried out according to the clinical criteria of the research team.
    1) Antecedente de lesión traumática cerebral con secuelas cognitivas y diagnóstico clínico de daño axonal difuso.
    2) Estudios de escalas clínicas (GCS, NIF, ASHWORTH, GOAT, DRS) así como estudios de neurofisiología y de PET-TAC que permitan contar con valores basales útiles, al objeto de que puedan ser comparados con las mismas exploraciones tras el tratamiento, y poder obtener datos objetivos de posible eficacia.
    3) Edad entre 18 y 70 años.
    4) Posibilidad de seguimiento evolutivo y apoyo neuro-rehabilitador durante el periodo de seguimiento.
    5) Consentimiento informado escrito, conforme a la legislación vigente.
    6) Parámetros hematológicos y de creatinina, SGOT y SGPT, en rango de normalidad, de acuerdo a los estándares del laboratorio, aceptándose, no obstante, modificaciones que se consideren no significativas en el contexto del tratamiento a realizar, según criterio clínico del equipo investigador.
    E.4Principal exclusion criteria
    1) Age below 18 or over 70.
    2) Pregnancy or lactation.
    3) Patients with systemic disease that is considered by the research team to represent an added risk to the treatment.
    4) Alterations in the performed genetic study to rule out risk of cell transformation in the expansion process.
    5) Patients with doubts regarding their possible cooperation during the study.
    6) Added neurodegenerative disease.
    7) Current or past drug addiction or psychiatric disease, as well as current or past cancer disease that may interfere in the study to the investigators' opinion.
    8) HIV Positive serology and/or syphillis or allergy to protein products used in the cell expansion process.
    9) Active Hepatitis B or Hepatitis C, according to the serology analysis.
    10) If in the opinion of the investigator there is some other cause for which the patient is not considered to be a candidate for the study.
    1) Edad inferior a 18 años o superior a 70.
    2) Embarazo o lactancia.
    3) Pacientes con enfermedad sistémica que se considere por el equipo investigador que puede representar un riesgo añadido al tratamiento.
    4) Alteraciones en el estudio genético realizado para descartar riesgo de transformación celular en el proceso de expansión.
    5) Pacientes con dudas acerca de su posible seguimiento durante el estudio.
    6) Enfermedad neurodegenerativa añadida.
    7) Drogadicción o enfermedad psiquiátrica, actual o pasada, así como enfermedad neoplásica actual o pasada, que a juicio de los investigadores pueda interferir en el estudio.
    8) Serología positiva a HIV y/o sífilis o alergia a los productos proteicos utilizados en el proceso de expansión celular
    9) Hepatitis B o Hepatitis C activa, de acuerdo al análisis de serología.
    10) Si en la opinión del investigador existe alguna otra causa por la cual el paciente no se considere candidato al estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Main assessment endpoints will be those related to the possible efficacy of the treatment which will be measured by means of changes in CGS, RSD, GOAT, ASHWORTH and NIF scales and in their subsection, as well as in neurophysiological studies and PET-TAC
    Las variables principales de evaluación serán las relacionadas con la posible eficacia del tratamiento que serán medidas mediante modificaciones en las escalas CGS, RSD, GOAT, ASHWORTH y NIF y sus subapartados, asi como estudios neurofisiológicos y de PET-TAC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Changes in CGS, RSD, GOAT, ASHWORTH and NIF scales: Month 1 baseline, Month 3, Month 6, Month 9 and Month 12 final assessment.

    Neurophysiological studies and PET-TA: Month 1 baseline and Month 12 final assessment.
    Modificaciones en las escalas CGS, RSD, GOAT, ASHWORTH y NIF: Mes 1 Evaluación basal , Mes 3 , Mes 6, Mes 9 y mes 12 evaluación final.

    Estudios neurofisiológicos y PET-TAC: Mes 1 evaluación basal y mes 12 evaluación final.
    E.5.2Secondary end point(s)
    Will be evaluated the possible adverse effects during CME administration, development of complications and other adverse effects after it and during the follow up period.
    Se evaluarán los posibles efectos adversos durante la administración de las CME, aparición de complicaciones y otros efectos adversos tras la misma y durante el periodo de seguimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 1 to Month 12.
    Mes 1 hasta Mes 12.
    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) 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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 Yes
    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 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)
    Not applicable
    No aplica
    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 Decision2017-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-12-15
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