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    Summary
    EudraCT Number:2015-005717-80
    Sponsor's Protocol Code Number:FAB117-CT-01
    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:2016-03-09
    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 number2015-005717-80
    A.3Full title of the trial
    Clinical trial of phase 1/2 to evaluate the feasibility, safety, tolerability and preliminary efficacy of the administration of FAB117-HC, a drug whose active ingredient is HC016, allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute traumatic spinal cord injury.
    Estudio clínico de Fase 1/2 para valorar la viabilidad, seguridad, tolerabilidad y eficacia preliminar de la administración de FAB117-HC, un medicamento cuyo principio activo es HC016, células mesenquimales troncales adultas alogénicas de tejido adiposo expandidas y pulsadas con H2O2, en pacientes con lesión medular aguda traumática.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of phase 1/2 to evaluate the feasibility, safety, tolerability and preliminary efficacy of the administration of FAB117-HC, a drug whose active ingredient is HC016, allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute traumatic spinal cord injury.
    Estudio clínico de Fase 1/2 para valorar la viabilidad, seguridad, tolerabilidad y eficacia preliminar de la administración de FAB117-HC, un medicamento cuyo principio activo es HC016, células mesenquimales troncales adultas alogénicas de tejido adiposo expandidas y pulsadas con H2O2, en pacientes con lesión medular aguda traumática.
    A.4.1Sponsor's protocol code numberFAB117-CT-01
    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 SponsorFerrer Internacional S.A
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHistocell S.L.
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportFerrer Internacional S.A
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerrer Internacional S.A.
    B.5.2Functional name of contact pointFerrer Advanced Biotherapeutics
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Diagonal 549; 5th floor
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08029
    B.5.3.4CountrySpain
    B.5.4Telephone number0034936.003.700
    B.5.5Fax number0034944.036.999
    B.5.6E-mailferreradvancedbiotherapeutics@ferrer.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 nameALLOGENEIC ADIPOSE DERIVED ADULT MESENCHYMAL STEM CELLS EXPANDED AND PULSED WITH H2O2 (HC016)
    D.3.2Product code FAB117-HC
    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 INNFAB117-HC
    D.3.9.2Current sponsor codeHC016
    D.3.9.3Other descriptive nameEXPANDED HUMAN ALLOGENEIC MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE
    D.3.9.4EV Substance CodeSUB30305
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.45 to 0.90
    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
    Patients with acute traumatic spinal cord injury
    Pacientes con lesión medular aguda traumática
    E.1.1.1Medical condition in easily understood language
    Patients with acute traumatic spinal cord injury
    Pacientes con lesión medular aguda traumática
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10043064
    E.1.2Term T7-T12 level spinal cord injury, unspecified
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10043046
    E.1.2Term T1-T6 level spinal cord injury, unspecified
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess safety and tolerability of intra-medullary administration of FAB117-HC, an allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2 (HC016) drug, in patients with acute thoracic spinal cord injury. The clinical assessments will be done: screening (2-24 h before drug administration), 24h, 72h, 7d, 14d, 28d and 90d after the drug administration)
    Evaluar la seguridad y tolerabilidad de la administración intramedular de FAB117-HC, un medicamento cuyo principio activo es HC016, células mesenquimales troncales adultas alogénicas de tejido adiposo expandidas y pulsadas con H2O2, en pacientes con lesión medular aguda traumática de nivel torácico. La evaluación clínica de los pacientes se efectuará en: la fase de selección (2-24h antes de la administración de FAB117-HC) y 24h, 72h, 7d, 14d, 28d y 90d después de la administración del medicamento celular.
    E.2.2Secondary objectives of the trial
    Investigate early signs of potential clinical efficacy of FAB117-HC by:
    1) Evaluation of motor, sensory and disability (ASIA) scores using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) at selection phase and 24h, 72h, 7d, 14d, 28d and 90d after the intra-medullary treatment with FAB117-HC. After completion of the trial, patients will be assessed at 180 and 360 follow-up period.
    2) Functional Assessment by Spinal Cord Independence Measure (SCIM III) on selection phase and 28day and 90day after FAB117-HC intra-medullary treatment
    3) Evaluate electrophysiological changes on 28day and 90day after FAB117-HC intra-medullary administration by:
    a. Somatosensory-Evoked Potentials (SSEP)
    b. Motor-Evoked Potentials (MEP):
    c. Nerve conduction velocities
    Investigar los indicios tempranos de potencial eficacia de FAB117-HC mediante:
    1) Evaluación de puntuaciones motoras, sensoriales y de discapacidad (ASIA) utilizando la escala: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) en la fase de selección y 24h, 72h, 7 días, 14 días, 28 días y 90 días después de la administración intramedular de FAB117-HC. Una vez concluido el ensayo, los pacientes serán evaluados a los 180 días y a los 360 días en abierto.
    2) Evaluación funcional mediante la Spinal Cord Independence Measure (SCIM III) en la fase de selección y 28 días y 90 días después de la administración intramedular de FAB117-HC.
    3) Evaluación de cambios electrofisiológicos 28 días y 90 días después de la administración intramedular de FAB117-HC. Se efectuarán medidas de:
    a. Potenciales evocados somatosensoriales (PESS por su acrónimo en inglés).
    b. Potenciales Evocados Motores (MEP por su acrónimo en inglés).
    c. Velocidades de conducción nerviosa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PHASE 1:
    1. Male or female subjects ? 18 to ? 65 years.
    2. ASIA A.
    3. Spinal Injury with neurological level between D5?D10 (cohorts 1 and 2)
    4. Single traumatic spinal cord injury as defined by MRI.
    5. Injury occurred between 72 and 120 h before undergoing DSS and treatment.
    6. Clinically and haemodynamically stable enough to undergo DSS.
    7. Able to give informed consent either in writing or verbally in the presence of a witness.

    PHASE 2:
    1. Male or female subjects ? 18 to ? 65 years.
    2. ASIA A or B.
    3. Spinal Injury with neurological level between (D1?D12) (D12 without ZPPM).
    4. Single traumatic spinal cord injury as defined by MRI.
    5. Injury occurring between 24 and 72h before undergoing DSS and treatment.
    6. Clinically and hemodynamically stable enough to undergo DSS.
    7. Able to give informed consent either in writing or verbally in the presence of a witness.
    FASE 1:
    1. Hombres y mujeres de 18 a 65 años.
    2. Lesión medular aguda traumática ASIA A.
    3. Lesiones medulares con nivel neurológico ubicado entre D5 a D10 (para las Cohortes 1 y 2).
    4. Existencia de una única lesión medular definible mediante RM.
    5. CEF entre las 72h y las 120h después del trauma.
    6. Hemodinámica y clínicamente estables para ser sometidos a cirugía de raquis.
    7. Consentimiento informado escrito del paciente o con un testigo cuando el paciente solo pueda darlo oralmente.

    FASE2:
    1. Hombres y mujeres de 18 a 65 años.
    2. Lesión medular aguda traumática ASIA A ó B.
    3. Lesiones medulares con nivel neurológico único entre D1 a D12 (D12 sin ZPPM).
    4. Existencia de una única lesión medular definible mediante RM.
    5. CEF entre las 48h y las 72h después del trauma.
    6. Hemodinámica y clínicamente estables para ser sometidos a cirugía de raquis.
    7. Consentimiento informado escrito del paciente o con un testigo cuando el paciente solo pueda darlo oralmente.
    E.4Principal exclusion criteria
    Research
    1. Participation in any clinical investigation within 28 days prior to spinal cord injury or if a cell therapy product has been administrated in the previous five years of SCI

    Local
    2. MRI or DSS evidence of complete spinal cord transection or equivalent severe lesion or abnormality.
    3. Inability to unequivocally identify the injection sites.
    4. Multiple injuries to the neurological spinal cord at different levels.
    5. Patients with any of these additional conditions:
    a. Penetrating spinal cord injuries.
    b. Associated trauma or injury to the brachial and / or lumbosacral plexus.
    6. Active infection in the surgical area.

    Surgical risk and clinical condition
    7. Haemodynamic instability contraindicating DSS procedure in the time frame defined for inclusion in the trial.
    8. Multiple organ failure.

    Neurological
    9. Significant head injury (Score on the Glasgow scale less than or equal to 13 and / or abnormal MRI/CT) or other injury that, in the investigator's opinion, is sufficient to interfere with the assessment of spinal cord function or compromise the validity of patient data.
    10. Patients undergoing mechanical ventilation that does not allow a prior clinical examination.
    11. Inability to communicate with the neurological examiner, so that the validity of patient data could be unreliable.
    12. Patients who are unconscious, including those unconscious to require sedative-analgesic medications.

    Basal condition and personal clinical history
    13. Preexisting or current significant diseases such as hepatitis C, HIV, epilepsy, neoplastic disease or other diseases that could cause neurological deficits, including syphilis, myelopathy, and polyneuropathy.

    14. Background or acute episode of Guillain?Barre syndrome.
    15. History of meningitis or meningoencephalitis.
    16. Current history of autoimmune disease.
    17. Patients with uncontrolled blood diathesis or under anticoagulant or antiplatelet pharmacological therapy.
    18. Presence of any psychiatric illness, as defined by the DSM-IV-TR, or medically unstable illness which can reasonably be expected to pose an increased risk to on participating in the study, or which causes a significant deterioration of the clinical course of the patient. Secondary depression is expressly excluded.
    19. Drug abuse as defined by DSM-IV-TR during the 6 months prior to SCI.
    20. Pregnant women.
    21. Women who are breastfeeding if unwilling to stop at the time of recruitment.
    22. History of life-threatening allergy or immune reaction.
    23. Patients with known hypersensitivity to any of the excipients of FAB117-HC.
    24. Patients with known or suspected hypersensitivity.to bovine serum, enzymes (trypsin, collagenase type I / II), penicillin, streptomycin or DMSO
    De investigación
    1. Participación en alguna investigación clínica dentro de los 28 días previas a la lesión medular o si se le ha sido administrado un producto de terapia celular en los cinco años anteriores a la lesión medular.

    Locales
    2. Cualquier transección anatómica completa o lesión de gravedad equivalente que se haya demostrado por RM o en la CEF.
    3. Imposibilidad para identificar de forma segura las zonas de inyección.
    4. Pacientes con múltiples lesiones medulares.
    5. Pacientes con alguna de las siguientes condiciones adicionales a la lesión medular:
    ? Lesiones penetrantes en médula espinal.
    ? Traumatismo o lesiones de plexo braquial y/o lumbosacro asociadas.
    6. Infección activa en la zona de abordaje quirúrgico.

    De riesgo quirúrgico y situación clínica
    7. Inestabilidad hemodinámica que contraindique el procedimiento de estabilización en el plazo definido para la inclusión en el ensayo.
    8. Fallo multiorgánico.

    Neurológicas
    9. Traumatismo craneoencefálico significativo (Puntuación en la escala de Glasgow inferior o igual a 13 y/o RM/TC anormal, entendiendo anormal como la presencia de edema, lesión axial y/o hemorragia) u otra lesión que en opinión del investigador sea suficiente para interferir en la valoración de la función medular o comprometer la validez de los datos del paciente.
    10. Pacientes sometidos a ventilación mecánica que no permita una exploración clínica previa.
    11. Incapacidad de comunicarse con el examinador neurológico de modo que la validez de los datos del paciente pueda ser poco fiable.
    12. Pacientes que se hallan inconscientes, incluidos los que están inconscientes por requerir sedo-analgesia.

    Basales y de historia médica
    13. Enfermedades significativas preexistentes o actuales como hepatitis C, VIH, epilepsia, procesos neoplásicos u otra enfermedad que pueda causar un déficit neurológicos incluyendo sífilis, mielopatía, polineuropatía.
    14. Antecedente o episodio agudo de síndrome de Guillain-Barre.
    15. Historial de meningitis o meningoencefalitis.
    16. Historial de enfermedad autoinmune actual.
    17. Pacientes con diátesis sanguínea incontrolada o en tratamiento anticoagulante o con fármacos antiagregantes plaquetarios.
    18. Presencia de cualquier enfermedad psiquiátrica, definida por el DSM-IV-TR, o medica inestable de la que razonablemente se pueda esperar que se sometiese al paciente a un riesgo no garantizado al participar en el estudio o que resultase un deterioro significativo del curso clínico del paciente. Se excluye expresamente la depresión secundaria.
    19. Drogodependencia definida por el DSM-IV-TR durante los 6 meses anteriores a la entrada en el estudio.
    20. Mujeres embarazadas.
    21. Mujeres lactantes que no hayan abandonado la lactancia en el momento del reclutamiento.
    22. Historial de alergia o reacción inmune con amenaza para la vida.
    23. Pacientes con hipersensibilidad conocida al excipiente de FAB117-HC.
    24. Pacientes con hipersensibilidad conocida o sospecha a sueros bovinos, enzimas (tripsina, colagenasa tipo I/II), penicilina, estreptomicina o DMSO.
    E.5 End points
    E.5.1Primary end point(s)
    The incidence of Serious Adverse Events, Adverse Events, and Clinical Assessments.
    Incidencia de acontecimientos adversos graves, acontecimientos adversos y evaluación clínica
    E.5.1.1Timepoint(s) of evaluation of this end point
    During all the study
    Durante todo el estudio
    E.5.2Secondary end point(s)
    -Variation on the motor and sensory scores from selection phase using the following scales: 1) Change on one or more levels in the disability scale (AIS) of the American Spinal Injury Association (ASIA); or 2) Increase of 5 points or more on the LENS punctuation of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
    -Changes on the functional assessment by Spinal Cord Independence Measure (SCIM III) on selection phase and 28day and 90day after FAB117-HC treatment
    -Changes on the electrophysiological assessment at 28day and 90day after FAB117-HC treatment by Somatosensory-Evoked Potentials and Motor-Evoked Potentials (MEP)
    -Changes on nerve conduction velocity test at 28day and 90day after FAB117-HC treatment
    - Cambios respecto a los valores de la fase de selección en la evaluación de puntuaciones motoras y sensoriales usando las siguientes escalas: 1) Pasar uno o más niveles en la Escala de discapacidad AIS de la American Spinal Injury Association (ASIA); o 2) Incrementar en 5 puntos o más el LEMS de la Escala International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
    -Cambios en la evaluación funcional mediante la Spinal Cord Independence Measure (SCIM III) en la fase de selección y 28 días y 90 días después de la administración intramedular de FAB117-HC.
    - Cambios en la evaluación electrofisiológica a los 28 días y 90 días después de la administración intramedular de FAB117-HC. Se efectuarán medidas de: Potenciales evocados somatosensoriales (PESS por su acrónimo en inglés) y Potencial Evocado Motor (MEP por su acrónimo en inglés).
    -Cambios en la evaluación de velocidades de conducción nerviosa a los 28 días y 90 días después de la administración intramedular de FAB117-HC
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Variation on the motor and sensory scores from selection
    -Spinal Cord Independence Measure (SCIM III) on selection phase and 28day and 90day after FAB117-HC treatment
    -Changes on the electrophysiological assessment at 28day and 90day after FAB117-HC treatment .
    -Changes on nerve conduction velocity test at 28day and 90day after FAB117-HC treatment
    - Cambios respecto a los valores de la fase de selección en la evaluación de puntuaciones motoras y sensoriales
    - Spinal Cord Independence Measure (SCIM III) en la fase de selección y 28 días y 90 días después de la administración intramedular de FAB117-HC.
    - Cambios electrofisiológicos 28 días y 90 días después de la administración intramedular de FAB117-HC.
    - Cambios en la evaluación de velocidades de conducción nerviosa a los 28 días y 90 días después de la administración intramedular de FAB117-HC
    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
    Feasibility and tolerability
    Viabilidad y tolerabilidad
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Fase1:abierto y Fase2: controlado,paralelo, aleatorizado,doble ciego parcial y seguimiento abierto
    Phase 1:open and Phase 2:controlled,parallel,randomized,partial double-blind,follow-up open label
    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
    el paciente no recibirá el tratamiento del estudio en la fase 2 grupo de referencia
    patient doesn't receive the study treatment in phase 2 reference group
    E.8.2.4Number of treatment arms in the trial2
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months48
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months48
    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: 46
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    Standard of care according to hospital protocol for the follow-up of this patients
    Práctica clínica habitual de acuerdo a los protocolos de cada hospital para el seguimiento de estos pacientes
    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 Decision2016-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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