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    Summary
    EudraCT Number:2011-006254-85
    Sponsor's Protocol Code Number:CeTMad/ELA/2011
    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:2012-08-09
    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 number2011-006254-85
    A.3Full title of the trial
    Placebo controlled, randomized and triple blind multicentric phase I/II clinical trial to evaluate the safety, feasibility and valoration of efficacy trends of intravenous administration of three doses of autologous adipose derived autologous mesenchymal stem cells (CeTMAd) in moderate/severe ALS patients.
    Ensayo clínico fase I/II multicéntrico, aleatorizado, controlado con placebo, triple ciego para evaluar la seguridad, factibilidad y valoración de tendencia de eficacia de la administración intravenosa de la terapia con 3 dosis de células mesenquimales autólogas de tejido adiposo en pacientes con Esclerosis Lateral Amiotrófica (ELA) moderada a severa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to value the safety and efficacy of administration of stem cells derived from own patient for the treatment of Amyotrophic Lateral Sclerosis (ALS).
    Ensayo clínico para valorar la seguridad y eficacia de la administración de células derivadas de tejido graso del propio paciente para el tratamiento de Esclerosis Lateral Amiotrófica (ELA).
    A.4.1Sponsor's protocol code numberCeTMad/ELA/2011
    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 PROGRESO Y SALUD
    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 PROGRESO Y SALUD
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓN PROGRESO Y SALUD
    B.5.2Functional name of contact pointROSARIO MATA ALCAZAR-CABALLERO
    B.5.3 Address:
    B.5.3.1Street AddressC/ Maese Rodrigo, nº 1, 1º Izq
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41001
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955 019 040
    B.5.5Fax number0034955 019 019
    B.5.6E-mailrosario.mata.exts@juntadeandalucia.es
    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 mesenquimales de tejido adiposo autólogo
    D.3.4Pharmaceutical form Suspension for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameCélulas Mesenquimales de tejido adiposo
    D.3.10 Strength
    D.3.10.1Concentration unit kg kilogram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4000000 to 1000000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amyotrophic lateral sclerosis (ALS)
    Esclerosis lateral amiotrófica (ELA)
    E.1.1.1Medical condition in easily understood language
    Amyotrophic lateral sclerosis (ALS)
    Esclerosis lateral amiotrófica (ELA)
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety evaluation and tolerability of the IV administration of 3 doses of autologous CeTMAd, measured by the ABSENCE of:
    -Complications at the site of infusion
    -Appearance of new neurological deficit not attributed to the natural progression of the disease:
    -Adverse events (OMS scale: clinical, haematological, bioquemical)
    Evaluación de seguridad y tolerabilidad medido por la AUSENCIA de:
    -Complicaciones en el lugar de la infusión;
    -Aparición de un nuevo efecto neurológico no atribuible a la progresión natural de esta patología;
    -Acontecimientos adversos durante el tratamiento.
    E.2.2Secondary objectives of the trial
    a) Evaluation of clinical efficacy of intravenous administration of 3 doses of autologous CeTMAd, measured by:

    ?Progression rate of the neurological dysfunction of the disease
    ?Muscle strength grading
    ?Changes in forced vital capacity
    ?Changes in muscle bulk and circumference of the upper and lower extremities:
    ?Changes in neurophysiological, neuropsychological and Quality of Life parameters
    ?Changes in the spasticity and pain measures
    ?Need of and time to tracheotomy or permanent assisted ventilation
    ?Need of and time to gastrostomy
    ?Overall survival, calculating time to death
    b) Inmmunological effects:
    ?Regulatory cell populations affecting the inflammatory and tolerogenic status and
    ?Immunological control mechanisms mediated by TLRs.

    c) Adquisition of metabolomic profiling data as an alternative tool for monitoring and identification of new markers in ALS.
    a)Evaluación de la eficacia de la administración:
    -Cambios en velocidad de progresión de la enfermedad ;
    -grado de fuerza muscular;
    -capacidad vital forzada;
    -masa muscular y circunferencia de las extremidades;
    -parámetros neurofisiológicos, neuropsicológicos y de calidad de vida;
    -medidas de espasticidad y de dolor;
    Necesidad y tiempo a:
    -traqueotomía o ventilación permanente asistida;
    -gastrostomía;
    -Supervivencia total.
    b)Efectos inmunomoduladores:
    -Poblaciones reguladoras del estatus inflamatorio y tolerogénico;
    -mecanismos de control inmunológico mediados por TLRs;
    c)Obtención de datos metabolómicos como herramienta alternativa de seguimiento e identificación de nuevos marcadores en ELA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Subjects > 18 years of age.
    ?Signed informed consent
    ?Diagnose established following the Escorial criteria from World Federation of Neurology
    ?Vital Capacity ? 50%
    ?More than 6 and less than 36 months of evolution of the disease
    ?Possibility of obtaining at least 50 grams of adipose tisue.
    ?Treated with riluzole
    1.Mujeres y varones adultos mayores de 18 años
    2.Buen entendimiento del protocolo y capacidad de otorgar el consentimiento informado
    3.Diagnóstico de ELA de acuerdo con el criterio El Escorial, de la Federación Mundial de Neurología
    4.Capacidad vital de al menos el 50% de la que les correspondería por sexo, altura y edad.
    5.Más de 6 y menos de 36 meses de evolución de la enfermedad
    6.Posibilidad de obtener, al menos, 50gr de tejido adiposo
    7.Tratamiento con riluzole
    E.4Principal exclusion criteria
    1.Any concurrent illness that could affect the measure of the clinical trial variables (hepatic, renal, cardiac insufficiency, diabetes mellitus, others)
    2.Previous stem cell therapy.
    3.Any lymphoproliferative disease.
    4.Riluzole with 4 weeks of study entry and at any time during the study.
    5.Hemophiliacs or subjects with bleeding disorders.
    6.Known hypersensitivity to fetal bovine serum
    7.HIV infection.
    8.Serum creatinine > 3.0 in subjects not on hemodialysis.
    9.Skin infection at the infusion site or systemic infection
    10.Active drug or alcohol addiction
    11.Pregnant, planning to become pregnant or not on accepted birth control method if subject is of child bearing potential.
    12.Subjects that are breast feeding
    13.Any condition that the Principal Investigator considers would render the subject unfit for the study.
    1.Cualquier enfermedad concomitante que pueda afectar las medidas de las variables clínicas del ensayo (insuficiencia hepática, renal o cardiaca, diabetes mellitus, etc).
    2.Terapia previa con células madre.
    3.Participación en otro ensayo clínico durante los 3 meses anteriores a la entrada en este ensayo.
    4.Cualquier enfermedad linfoproliferativa
    5.Hemofilia, diátesis hemorrágica o terapia anticoagulante actual.
    6.Hipersensibilidad conocida al suero bovino fetal o la gentamicina.
    7.Antecedentes médicos de infección por el Virus de la Inmunodeficiencia Humana (VIH) o cualquier estado inmunocomprometido grave.
    8.Niveles de creatinina en suero > 3.0 en sujetos no sometidos a hemodiálisis.
    9.Infección cutánea en el lugar de la inyección o infección sistémica.
    10.Adición a alcohol o drogas.
    11.Embarazo, planificación para quedar embarazada o pacientes en edad fértil no sometidas a métodos de control de natalidad.
    12.Mujeres durante la lactancia.
    13.Cualquier otra condición por la que, a juicio del investigador principal, considere que el sujeto no se ajusta al estudio (incluyendo presencia de traqueostomia y/o gastrostomia)
    E.5 End points
    E.5.1Primary end point(s)
    -Adverse events (OMS scale): cuantitative variable (number of events); cualitative variable (severity)
    -Complications at the site of infusion: cuantitative variable (number of events); cualitative variable (severity)
    -Appearance of new neurological deficit not attributed to the natural progression of the disease: cuantitative variable (number of events); cualitative variable (severity)
    -Laboratory analysis: cuantitative variables.
    ?Efectos adversos (escala OMS): variable cuantitativa (número de eventos); variable cualitativa (gravedad)
    ?Complicaciones en el lugar de la infusión: variable cuantitativa (número de eventos); variable cualitativa (severidad)
    ?Aparición de nuevos déficits neurológicos no atribuidos a la progresión normal de la enfermedad: variable cuantitativa (número de eventos); variable cualitativa (gravedad)
    ?Análisis básico de Laboratorio: variables hematológicas, bioquímicas o inmunológicas cuantitativas
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplicable
    E.5.2Secondary end point(s)
    Secondary variables:
    Clinical variables
    ? Sex: cualitative variable variable (male, female).
    ? Age: cuantitative variable (years)
    ? Age at beginning of illness: cuantitative variable (years)
    ? Neurological dysfunction measured by Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) at beginning of the clinical trial: cuantitative variable
    ?Progression rate of the disease as evidenced by changes in the ALS functional rating scale (ALSFRS-R): cuantitative variable
    ?Muscle strength grading (measured by Manual Muscular Testing (MMT) and the Maximal Voluntary Isometric Contraction (MVIC): cuantitative variables
    ?Changes in forced vital capacity (FVC %): cuantitative variable
    ?Changes in upper and lower extremities circumference (cm): cuantitative variables
    ?Need of tracheotomy or permanent assisted ventilation: cualitative variable
    ?Time to tracheotomy or permanent assisted ventilation: cuantitative variable
    ?Overall survival, calculating time to death: cualitative variable
    ?Changes in the spasticity Ashworth scale: cuantitative variable
    ?Changes in the Visual analogue scale (VAS) of pain and in McGill Pain Questionnaire: cuantitative variable

    Inmmunological análisis:

    ?Cellular subpopulations ( T CD4+, T CD8+, NK y monocytes): cuantitative variable (nº,%).
    ?IFN-?, TNF-?, IL-2, IL-12, IL-4, IL-5, IL-10, IL-17A, IL-23 and IL-6: cuantitative variables.

    Neurophysiological variables: cuantitative variables:
    ?Changes in Neurophysiological Index (NI)
    ?in Motor unit number estimation (MUNE)
    ? in magnetic Motor evoked potentials (MEP) amplitude
    ?in excitability thereshold of MEP

    Magnetic Resonance Imaging (MRI) variables:
    ?Changes in muscle bulk estimated by MRI of the upper and lower extremities: cuantitative variables
    Neuropsychological variables :
    ?Escala de Inteligencia de Wechsler para Adultos. WAIS-III:
    Variables cuantitativas
    Quality of life variables:
    ?Changes in the quality of life measured by Sickness Impact Profile: cuantitative variable
    Variables clínicas:
    ?Sexo: variable cualitativa (hombre, mujer)
    ?Edad: variable cuantitativa (años)
    ?Edad al comienzo de la enfermedad: variable cuantitativa (años)
    ?Disfunción neurológica medida por la escala de puntuación funcional de la ELA (ALSFRS-R): variable cuantitativa
    ?Progresión de la tasa de enfermedad evidenciada por cambios en la escala funcional de ELA (ALSFRS-R): variable cuantitativa.
    ?Disminución de la masa muscular (medida por el ?Test Muscular Manual? (MMT) y la ?Contracción Isométrica Voluntaria Máxima? (MVIC): variable cuantitativa
    ?Cambios en la capacidad vital forzada (CVF %): variable cuantitativa
    ?Cambios en la circunferencia de la extremidades superiores e inferiores: variable cuantitativa
    ?Necesidad de traqueotomía o ventilación asistida permanente: variable cualitativa
    ?Tiempo a traqueotomía o ventilación asistida permanente: variable cuantitativa
    ?Necesidad de gastrostomía: variable cualitativa
    ?Tiempo a gastrostomía: variable cuantitativa
    ?Supervivencia global, calculada hasta el momento de la muerte: variable cuantitativa
    ?Cambios en la escala de espasticidad de Ashworth: variable cuantitativa
    ?Cambios en la escala análoga visual (VAS) de dolor y cuestionario de dolor McGill: variable cuantitativa
    Análisis inmunológicos
    1)Cuantificación de los fenotipos de células T reguladoras y diferenciación de células TH1/TH17
    2)Caracterización de los niveles de expresión de TLRs sobre CD4+ y CD8+
    3)Caracterización de las células Treg productoras de IL17
    4)Caracterización funcional de la capacidad supresora de las células T reguladoras
    5)Caracterización de producción y liberación de citocinas Th1/Th2/Th9 en PBMCs
    6)Caracterización funcional de la respuesta a TLRs en CD4+ y CD8+
    7)Aislamiento de mRNA de PBMC para estudios
    Variables neurofisiológicas: Variables cuantitativas definidas por cambios en:
    ?índice neurofisiológico
    ?estimación del nº unidades motoras ?Motor unit Lumber estimulation (MUNE)?
    ?amplitud de los potenciales evocados motores (PEM)
    ?umbral de excitabilidad de PEM
    Variables de imagen por resonancia magnética (RMN): Cambios en la masa muscular estimada por RMN de las extremidades superiores e inferiores: variable cuantitativa.
    Variables neuropsicológicas: Escala de inteligencia de Wechsler para adultos (WAIS-III): variable cuantitativa.
    Cambios en la calidad de vida medida por el perfil de impacto de la enfermedad (Sickness Impact Profile) : variable cuantitativa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplicable
    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 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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    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
    Not applicable
    No aplicable
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state40
    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 aplicable
    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 Decision2013-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-16
    P. End of Trial
    P.End of Trial StatusOngoing
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