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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-005684-24
    Sponsor's Protocol Code Number:CME-LEM2
    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:2013-10-18
    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 number2011-005684-24
    A.3Full title of the trial
    Subarachnoid administration of autologous bone marrow stromal cells in incomplete spinal cord injury.
    Administración subaracnoidea de células estromales autólogas de médula ósea en lesiones incompletas de la médula espinal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Administration of bone marrow stromal cells in incomplete spinal cord injury.
    Administración de células de médula ósea en lesiones incompletas de la médula espinal
    A.4.1Sponsor's protocol code numberCME-LEM2
    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 supportFundación Investigación Biomédica Hospital Universitario Puerta de Hierro
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportMinisterio de Sanidad, Política Social e Igualdad
    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 pointCRO
    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+34913275025
    B.5.5Fax number+34917542721
    B.5.6E-mailstart-up@sermes.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 madre autólogas obtenidas del estroma de medula ósea
    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 madre autólogas obtenidas del estroma de medula ósea
    D.3.9.2Current sponsor codeCME-LEM 2
    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) 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
    Incomplete spinal cord injury, due to traumatical or ischemic cause.
    Lesión medular incompleta, de causa traumática o isquémica.
    E.1.1.1Medical condition in easily understood language
    Incomplete spinal cord injury.
    Lesiones incompletas de la médula espinal.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level HLT
    E.1.2Classification code 10041545
    E.1.2Term Spinal cord and nerve root disorders traumatic
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Analyze the possible clinical efficacy of the administration of autologous stromal cells from the bone marrow expanded "in vitro" in the treatment of spinal cord injury patients (SCI) chronically established and incomplete (ASIA B, C or D).
    Analizar la posible eficacia clínica de la administración de células autólogas del estroma de la médula ósea expandidas “in vitro” en el tratamiento de pacientes con lesión medular (LEM) crónicamente establecida e incompleta (ASIA B, C o D).
    E.2.2Secondary objectives of the trial
    1) Confirm the safety of treatment, and 2) study possible changes in the levels of CSF neurotrophic factors (BDNF, GDNF, NGF, CNTF, NT3 and NT4) after subarachnoid CME administration.
    1) Confirmar la seguridad del tratamiento, y 2) Estudiar las posibles modificaciones en los niveles de factores neutróficos en LCR (BDNF, GDNF, NGF, CNTF, NT3 y NT4) tras la administración subaracnoidea de CME.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Incomplete spinal cord injury (level B, C or D on ASIA and Frankel scales)
    2) Neurological deficit clinically stable at least 12 months prior to treatment, and with a minimum of one-year evolution after spinal cord injury.
    3) Neurophysiological confirmation of incomplete spinal cord injury.
    4) MRI study showing the morphology of spinal cord injury.
    5) Age between 18 and 70 years.
    6) Ability to perform physical therapy throughout the treatment period.
    7) Written informed consent.
    8) Hematological parameters and creatinine, SGOT and SGPT values, within the normal range according to laboratory standards values, accepting, however, slight deviations which may not be considered significant in the context of the treatment to be performed, based on clinical judgment of the research team
    1) Lesión medular incompleta (nivel B, C o D en escalas de ASIA y Frankel).
    2) Lesión clínicamente estable, al menos en los 12 meses previos al inicio del ensayo, y con una evolución mínima de un año desde el momento en que se produjo la lesión.
    3) Confirmación neurofisiológica de lesión medular incompleta.
    4) Estudio de RM medular que permita valorar morfológicamente la lesión medular.
    5) Edad mayor de 18 años y menor de 70.
    6) Posibilidad de seguimiento evolutivo y de realizar fisioterapia ambulatoria, 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.Clinical evaluation as complete SCI according to the ASIA or FRANKEL scales.
    2.Neurophysiological records showing complete SCI.
    3.Age below 18 years or above 70.
    4.Pregnancy or breastfeeding.
    5.Neoplastic disease present or in previous 5 years.(diagnosed or treated)
    6.Patients with systemic disease that represents an added risk to treatment.
    7.Patients with inability to perform a program of physical therapy during the study, or negative report in psychological assessment previous to inclusion.
    8.Inability to assess MRI features of the SCI, either by artifacts inherent to spinal stabilization systems or any other cause.
    9.Patients treated with hematopoietic growth factors or requiring maintained anticoagulation.
    10.Neurodegenerative disease.
    11.History of substance abuse, psychiatric disease or allergy to the proteins used in the process of cell expansion.
    12.Positive serology for HIV and syphilis.
    13.Active Hepatitis B or Hepatitis C.
    14.If in the opinion of the investigator is there some other reason why the patient is not considered a candidate for cell therapy.
    1) Clasificación ASIA A o Frankel A, en las escalas clínicas de valoración de lesión medular.
    2) Registros neurofisiológicos compatibles con lesión medular completa.
    3) Edad inferior a 18 años o superior a 70.
    4) Embarazo o lactancia.
    5) Enfermedad neoplásica actual o bien en los 5 años previos (diagnosticada o tratada).
    6) Pacientes con enfermedad sistémica que represente un riesgo añadido al tratamiento
    7) Pacientes con dudas acerca de su posible cooperación en el mantenimiento de fisioterapia o de controles durante el estudio, o con informe negativo en la valoración psicológica previa.
    8) Imposibilidad de valorar por RM las características de la lesión, ya sea por artefactos inherentes a sistemas de estabilización vertebral o cualquier otra causa.
    9) Pacientes recibiendo tratamiento con factores de crecimiento hematopoyéticos o que requieran anticoagulación mantenida.
    10) Enfermedad neurodegenerativa añadida.
    11) Historia de drogadicción, de enfermedad psiquiátrica o de alergia a los productos proteicos utilizados en el proceso de expansión celular.
    12) Serologia positiva a HIV y sífilis.
    13) Hepatitis B o Hepatitis C activa.
    14) Si en la opinión del investigador existe alguna otra causa por la cual el paciente no se considere candidato a terapia celular.
    E.5 End points
    E.5.1Primary end point(s)
    -Changes in ASIA, FRANKEL, IANR-SCIFRS, NIF, Barthel, PENN, ASHWORTH and EVA 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 in cases where sphincter function is impaired prior to treatment.
    - Modificaciones en las escalas ASIA, FRANKEL, IANR-SCIFRS, NIF, BARTHEL, PENN, ASHWORTH y EVA.
    - 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 en los casos en que exista alteración previa al tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the follow up period.
    Durante el periodo de seguimiento.
    E.5.2Secondary end point(s)
    The changes in levels of neurotrophic factors in LCR after subaracnoid administration of Cerebrospinal fluids, adverse events during the administration and during following period.
    Posibles modificaciones en los niveles de factores neurotróficos en LCR tras la administración subaracnoidea de CME, así como 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 the 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 Yes
    E.6.13.1Other scope of the trial description
    Changes in neurotrophic factors levels in cerebrospinal fluid during treatment.
    Modificaciones en los niveles de factores neurotróficos en LCR durante el tratamiento.
    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 No
    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 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: 9
    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 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 Decision2014-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-28
    P. End of Trial
    P.End of Trial StatusCompleted
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