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    Summary
    EudraCT Number:2015-002383-16
    Sponsor's Protocol Code Number:CME-LEM4
    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:2015-10-15
    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 number2015-002383-16
    A.3Full title of the trial
    Evaluate the efficacy of the cell therapy with NC1 medication in patients with post-traumatic syringomyelia
    Evaluación de la eficacia del medicamento de terapia celular NC1 en pacientes con siringomielia postraumática
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate the efficacy of the cell therapy with NC1 medication in patients with post-traumatic syringomyelia
    Evaluación de la eficacia del medicamento de terapia celular NC1 en pacientes con siringomielia postraumática
    A.4.1Sponsor's protocol code numberCME-LEM4
    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 Investigación Biomédica Hospital Universitario Puerta de Hierro
    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-LEM4
    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 médula ósea expandidas
    D.3.9.2Current sponsor codeCME-LEM4
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300000000
    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 spinal cord injury, chronically established, associated with syringomyelia and neurological deficit considered irreversible.
    Lesión medular de causa traumática, crónicamente establecida,
    asociada a siringomielia y con déficit neurológico considerado
    irreversible.
    E.1.1.1Medical condition in easily understood language
    Traumatic spinal cord injury associated with syringomyelia
    Lesión medular de causa traumática asociada a siringomielia
    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 the administration in the intrathecal compartment, ( intramedullary and in the subarachnoid space), of the medication NC1, to improve the neurological sequels of patients with established chronic spinal cord injury (LEM) and post-traumatic syringomyelia.
    Analizar la posible eficacia clínica de la administración en el compartimento intratecal, (intramedular y en espacio subaracnoideo) del medicamento NC1, para mejorar las secuelas neurológicas de pacientes con lesión medular (LEM) crónicamente establecida y que han desarrollado una siringomielia postraumática.
    E.2.2Secondary objectives of the trial
    Confirm the treatment security.
    Confirmar la seguridad del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Post-traumatic spinal cord injury patients (Level A, B, C or D in ASIA scales), with associated syringomyelia extended at least in three vertebral segments, and neurological stable clinic for at least 6 months prior to study start.
    2.Previous studies of Neurophysiology, MRI and Urology (if neurogenic bladder data exist) and defecatory activity (if neurogenic intestine signs exist) to allow useful baseline, in order that they can be compared with the same scans at the end of the follow uo period, and to obtain objective data of potential efficacy.
    3.Age between 18 and 70 years.
    4.Neuroimagin (MR) that allow to confirm the syringomyelic cavity existence extended at lest 3 vertebral segments.
    5.Men and women of childbearing age must compromisse to use contraceptives from the time at which the removal of cells from the bone marrow is performed until 6 months after the celular administration.
    6.Possibility of follow up and commitment to perform ambulatory physical therapy, at least one hour per day, five days per week, throughout all treatment period.
    7.Written informed consent, according to the law in force.
    8.Hematologic, creatinine, SGOT and SGPT parameters, within the normal range, according to laboratory standards. However, slight modifications that are considered significant in the context of treatment to be performed, according to the criterion of the research team, are accepted.
    1.Pacientes con lesión medular traumática (nivel A, B, C o D en escalas de ASIA), con siringomielia asociada que se extiende al menos tres segmentos vertebrales, y con clínica neurológica estable al menos en los 6 meses previos al inicio del ensayo.
    2.Estudios previos de Neurofisiología, Resonancia Magnética, Urología (si existen datos de vejiga neurógena) y de actividad defecatoria (si existen signos de intestino neurógeno) que permitan contar con valores basales útiles, al objeto de que puedan ser comparados con las mismas exploraciones al final del periodo de seguimiento, y poder obtener datos objetivos de posible eficacia.
    3) Edad entre 18 y 70 años.
    4) Neuroimagen (RM) que permita confirmar la existencia de cavidad siringomiélica extendiéndose al menos 3 segmentos vertebrales
    5) Mujeres y hombres en edad fértil deberán comprometerse a utilizar medidas de anticoncepción desde el momento en que se le realice la extracción de células de su médula ósea hasta 6 meses después de la administración de CME.
    6) Posibilidad de seguimiento evolutivo y compromiso de realizar fisioterapia
    ambulatoria, al menos una hora diaria, cinco días a la semana, durante todo el periodo de tratamiento.
    7) Consentimiento informado escrito, conforme a la legislación vigente.
    8) Parámetros hematológicos y de creatinina, SGOT y SGPT, en rango de normalidad, de acuerdo a los estándares del laboratorio, aceptándose, no obstante, ligeras 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 years or above 70.
    2. Pregnancy or lactation.
    3. Current neoplastic disease or in the previous 5 years (diagnosed or treated).
    4. Patients with systemic disease or other pathology that represents an added risk to the cellular therapy treatment or to the surgical operation.
    5. Alterations in the genetic study performed to discard risk cell transformation in the expansion process.
    6. Patients with doubts about possible cooperation in the maintenance physical therapy or in the controls carried out during the study
    7. Neurodegenerative disease added.
    8. History of substance abuse, psychiatric disease or allergy to protein products used in the process of cell expansion.
    9. Positive serology for HIV and syphilis.
    10. Active Hepatitis B or Hepatitis C, according to serology analysis.
    11. If in the opinion of the researcher there is some other reason why the patient is not considered candidate for the study.
    1.Edad inferior a 18 años o superior a 70.
    2.Embarazo o lactancia.
    3.Enfermedad neoplásica actual o bien en los 5 años previos (diagnosticada o tratada).
    4.Pacientes con enfermedad sistémica o cualquier otra patología que se considere
    puede representar un riesgo añadido al tratamiento de terapia celular o a la
    intervención quirúrgica
    5.Alteraciones en el estudio genético realizado para descartar riesgo de
    transformación celular en el proceso de expansión.
    6.Pacientes con dudas acerca de su posible cooperación en el mantenimiento de fisioterapia o de controles durante el estudio.
    7.Enfermedad neurodegenerativa añadida.
    8.Historia de drogadicción, de enfermedad psiquiátrica, o de alergia a los productos proteicos utilizados en el proceso de expansión celular.
    9.Serología positiva a HIV y/o sífilis.
    10.Hepatitis B o Hepatitis C activa, de acuerdo al análisis de serología.
    11.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)
    -Changes in ASIA scales and its subsections, as well as in IANR-SCIFRS, PENN, ASHWORTH, EVA, GEFFNER and BDS scales.
    -Changes in the neurophysiological records (somato-sensory evoked potentials, motor evoked potentials and EMG).
    -Changes in spinal cord morphology in neuroimaging studies (MRI).
    -Changes in urodynamic records and defecatory function.
    - Modificaciones en las escalas ASIA y sus subapartados, así como en las
    escalas IANR-SCIFRS, PENN, ASHWORTH, EVA, GEFFNER y BDS.
    - Modificaciones en los registros neurofisiológicos (Potenciales evocados
    somato- sensoriales, Potenciales evocados motores y EMG).
    - Modificaciones de la morfología medular, tras estudio de neuroimagen (RM de
    alta definición).
    - Modificaciones en registros urodinámicos y de función defecatoria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy will be assessed taking into account the changes in score of the different scales between the patient inclusion moment in the study and the scores obtained at the end of the follow up period, according to the clinic scales assessment and the objective study results (MR, neurophysiological records, urodynamic records and defecatory activity).
    La eficacia se evaluará teniendo en cuenta la variación en la puntuación de las
    diferentes escalas entre el momento de la inclusión del paciente en el estudio y las puntuaciones obtenidas al final del periodo de seguimiento, tanto en lo que respecta a la valoración de escalas clínicas como al resultado de los estudios objetivos (RM, y registros neurofisiológicos, así como registros urodinámicos y de actividad defecatoria).
    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
    During follow up period.
    Durante el periodo de seguimiento
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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 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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state6
    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 Decision2016-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
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