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    Summary
    EudraCT Number:2013-000534-35
    Sponsor's Protocol Code Number:CSM/CIT
    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:2013-04-09
    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 number2013-000534-35
    A.3Full title of the trial
    Phase II clinical trial in the treatment of cytopenias allogeneic post-transplant with a sequential infusion of allogeneic mesenchymal cells expanded in vitro.
    ENSAYO CLÍNICO EN FASE II DE TRATAMIENTO DE CITOPENIAS POSTRASPLANTE ALOGÉNICO CON INFUSION SECUENCIAL DE CÉLULAS MESENQUIMALES ALOGÉNICAS EXPANDIDAS IN VITRO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial in patients undergoing allo-transplant of hematopoietic stem cell (allo-HSCT) who have developed one or more post-transplant cytopenias
    Ensayo clínico en pacientes sometidos a alotrasplante de progenitores hematopoyéticos (alo-TPH) que hayan desarrollado una o varias citopenias postrasplante.
    A.4.1Sponsor's protocol code numberCSM/CIT
    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 Castellano Leonesa de Hematología y Hemoterapia (FUCALHH)
    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 supportministerio de Sanidad Servicios Sociales e Igualdad
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGradocell Pharma S.L.
    B.5.2Functional name of contact pointMayte Fresneda
    B.5.3 Address:
    B.5.3.1Street AddressSantiago Grisolia 2
    B.5.3.2Town/ cityTres Cantos
    B.5.3.3Post codeMadrid
    B.5.3.4CountrySpain
    B.5.4Telephone number34655453091
    B.5.6E-mailmfresneda@gradocell.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 nameMesenchymal stem cells
    D.3.4Pharmaceutical form Suspension for injection
    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 INNNONE
    D.3.9.3Other descriptive nameEx vivo cultured human mesenchymal stem cells
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/g million organisms/gram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2100
    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
    Allogeneic post-transplant cytopenias.
    Citopenia/s post-transplante alogénico.
    E.1.1.1Medical condition in easily understood language
    Allogeneic transplantation peripheral cytopenias are those which occur after the proper graft hematopoietic progenitors.
    Las citopenias periféricas postrasplante alogénico son aquellas que se producen tras el injerto adecuado de los progenitores hematopoyéticos.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    Analyze the safety of the infusion of allogeneic mesenchymal stem cells (MSCs) expanded "in vitro" with platelet lysate in absence of animal products in the treatment of patients undergoing allo-TPH having developed one or more cytopenias posttransplant.
    Safety is measured in terms of:
    ? Adverse effects upon infusion
    ? Emergence of infectious complications after infusion of MSC.
    Analizar la seguridad de la infusión de células stem mesenquimales (CSM) alogénicas expandidas ?in vitro? con lisado plaquetario en ausencia de productos derivados de animales en el tratamiento de pacientes sometidos a un alo-TPH que hayan desarrollado una o varias citopenias postrasplante.
    La seguridad se medirá en términos de:
    ? Efectos adversos en el momento de la infusión
    ? Aparición de complicaciones infecciosas tras la infusión de CSM.
    E.2.2Secondary objectives of the trial
    Analyze the efficacy of the procedure measured in terms of clinical response:
    ? Recovery hemoperiféricas figures
    ? Duration of response / relapse incidence
    To analyze the influence of the infusion of MSC in the risk of relapse after transplantation of the underlying disease.
    To study the influence of the infusion of MSC in overall survival and disease-free survival.
    Analizar la eficacia del procedimiento medida en términos de respuesta clínica:
    ? Recuperación de cifras hemoperiféricas
    ? Duración de la respuesta / incidencia de recaídas
    Analizar la influencia de la infusión de CSM en el riesgo de recaída postrasplante de la enfermedad de base.
    Estudiar la influencia de la infusión de CSM en la supervivencia global y en la supervivencia libre de enfermedad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with hematologic malignancies who have undergone allo-HSCT and are diagnosed with one or more cytopenias peripheral with full chimerism in bone marrow. They may be included:
    a. Patients who have received BM or PS as cell source
    b. Patients who have received cells from a family donor or HLA-matched unrelated
    c. Patients transplanted with myeloablative or nonmyeloablative conditioning.
    2. Patients must have adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process.
    3. Adequate pulmonary function with no evidence of obstructive or restrictive pulmonary disease severe.
    4. Patients between 18 and 70 years
    5. Signature of informed consent
    1. Pacientes con hemopatías malignas que hayan sido sometidos a alo-TPH y que sean diagnosticados de una o más citopenias periféricas con quimerismo completo en médula ósea. Podrán incluirse
    a. Pacientes que hayan recibido como fuente de células MO o SP
    b. Pacientes que hayan recibido células de un donante familiar o no emparentado HLA compatible
    c. Pacientes trasplantados con acondicionamiento mieloablativo o no mieloablativo.
    2. Los pacientes deben tener una adecuada función cardiaca sin evidencia de hipertensión incontrolada, Insuficiencia cardiaca congestiva, angor pectoris o IAM en los 6 meses previos al proceso.
    3. Adecuada función pulmonar sin evidencia de enfermedad pulmonar obstructiva o restrictiva severa.
    4. Pacientes entre 18 y 70 años
    5. Firma del consentimiento informado
    E.4Principal exclusion criteria
    1. Patients whose blood disease has not been controlled by the transplantation or is in progress at the time of treatment.
    2. Patients who do not have full chimerism in bone marrow
    3. Patients with bacterial, viral or fungal infection that is not being controlled with proper treatment.
    4. Patients with poor cardiac function and / or pulmonary
    5. Patients that on investigator judgment are not in a good position to tolerate treatment
    6. Patients who do not have the required donor.
    7. Pregnant women or with risk of pregnancy due to inadequate contraceptive measures.
    8. Patients <18 or> 70 years.
    9. Patients who do not sign the consent form.
    1. Pacientes cuya hemopatía no haya sido controlada por el trasplante o esté en progresión en el momento del tratamiento.
    2. Pacientes que no tengan quimerismo completo en médula ósea
    3. Pacientes con infección bacteriana, vírica o fúngica que no esté siendo controlada con el tratamiento adecuado.
    4. Pacientes con mala función cardiaca y/o pulmonar
    5. Pacientes que a juicio del investigador no estén en una situación adecuada para tolerar el tratamiento
    6. Pacientes que no tengan el donante requerido.
    7. Mujeres gestantes o con riesgo de embarazo por medidas anticonceptivas inadecuadas.
    8. Pacientes < 18 o > 70 años.
    9. Pacientes que no firmen el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Safety of the procedure.
    Seguridad del procedimiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety is measured in terms of:
    ? Adverse effects upon infusion
    ? Emergence of infectious complications after infusion of MSC.
    La seguridad se medirá en términos de:
    ? Efectos adversos en el momento de la infusión
    ? Aparición de complicaciones infecciosas tras la infusión de CSM.
    E.5.2Secondary end point(s)
    Efficacy of the procedure
    Eficaia del procedimiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy od the procedure is measured in terms of clinical response:
    ? Recovery hemo-peripheral figures (depending on the cytopenia original):
    - Complete response:
    ? Hb> 11 g / dL
    ? Neutrophils> 1.0x10e9 / L
    ? Platelets> 100 x10e9 / L
    Maintained at least 7 days
    - Partial response:
    ? Hb 10-11 g / dL
    ? Neutrophils > 0.5 and <1.0 x10e9 / L
    ? Platelets > 50 and <100 x10e9 / L
    Maintained at least 7 days
    La eficacia del procedimiento es medida en términos de respuesta clínica:
    ? Recuperación de cifras hemoperiféricas (dependiendo de la citopenia original):
    - Respuesta completa:
    ? Hb>11 g/dL
    ? Neutrófilos >1.0x10e9/L
    ? Plaquetas >100 x10e9/L
    Mantenido al menos 7 días
    - Respuesta parcial:
    ? Hb 10-11 g/dL
    ? Neutrófilos >0.5 y <1.0 x10e9/L
    ? Plaquetas >50 y <100 x10e9/L
    Mantenido al menos 7 días
    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) 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 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
    Since the last infusion of the MSC to last patient recruited and until the end of the follow-up, it will be 90 days post-administration.
    In the first two years 15 patients plannedwill be included in the study and they will be monitor (follow-up) for a period of 90 days after the last dose of mesenchymal cells.
    Desde la última infusión de las CSM al último paciente reclutado y hasta el fin del seguimiento, será de 90 días post-administración.
    En los primeros 2 años serán incluidos en el estudio los 15 enfermos previstos, y se realizará un seguimiento de los mismos durante un periodo de 90 días desde la última dosis de células mesenquimales.
    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 months3
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state15
    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)
    Expected normal treatment.
    Tratamiento normal esperado.
    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 Decision2013-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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