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    Summary
    EudraCT Number:2022-000243-80
    Sponsor's Protocol Code Number:MSV_LE
    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:2022-05-06
    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 number2022-000243-80
    A.3Full title of the trial
    PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF MESENCHYMAL CELLS (MSV-allo®) IN THE TREATMENT OF LUPUS
    NEPHRITIS.
    ENSAYO CLÍNICO FASE II, DOBLE CIEGO, CONTROLADO CON PLACEBO, PARA EVALUAR LA SEGURIDAD Y EFICACIA DE LAS CÉLULAS MESENQUIMALES (MSV-allo®) EN EL TRATAMIENTO DE LA NEFRITIS LÚPICA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LUPUS NEPHRITIS TREATMENT WITH MESENCHYMAL CELLS (MSV-allo®).
    TRATAMIENTO DE LA NEFRITIS LÚPICA con células mesenquimales (MSV-allo®).
    A.3.2Name or abbreviated title of the trial where available
    LUPUS NEPHRITIS TREATMENT WITH MESENCHYMAL CELLS (MSV-allo®)
    TRATAMIENTO DE LA NEFRITIS LÚPICA con células mesenquimales (MSV-allo®)
    A.4.1Sponsor's protocol code numberMSV_LE
    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 SponsorHospital Universitario Rio Hortega
    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 supportEn tramite
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Rio Hortega
    B.5.2Functional name of contact pointRosa Conde
    B.5.3 Address:
    B.5.3.1Street AddressC/ Dulzaina, 2
    B.5.3.2Town/ cityValladolid
    B.5.3.3Post code47012
    B.5.3.4CountrySpain
    B.5.4Telephone number+34608212865
    B.5.6E-mailrconvi@saludcastillayleon.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 nameAllogeneic adult mesenchymal stem cells bone marrow derived expanded in suspension
    D.3.2Product code MSV®-allo
    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 INNcélulas mesenquimales troncales adultas alogénicas de médula ósea expandidas mediante procedimiento IBGM
    D.3.9.2Current sponsor codeMSV_allo
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    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
    Lupus nephritis
    Nefritis lúpica
    E.1.1.1Medical condition in easily understood language
    Lupus nephritis
    Nefritis lúpica
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary 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 and efficacy assessing of MSV-allo® compared to placebo to achieve complete or parcial lupus nephritis remision after the indution period
    Evaluar la seguridad y eficacia de las MSV-allo® comparada con placebo, para obtener la remisión completa o parcial, en la NL activa durante el período de inducción.
    E.2.2Secondary objectives of the trial
    1. Time to achieve complete or partial remission after transplantation with MSV-allo®.
    2. Time to maintain response.
    3. Effect on corticosteroids use reduction during induction period.
    4. Effect on immunosuppressants use reduction during induction period.
    5. Safety, tolerability and immunogenicity profiles of MSV-allo® in Lupus nephritis patients.
    6. MSV-allo® effect on pacients life quality.
    1. Tiempo que se tarda en alcanzar la remisión completa o parcial después del trasplante con MSV-allo®.
    2. Tiempo de mantenimiento de la respuesta.
    3. Efecto sobre la reducción del uso de corticoides en el período de inducción.
    4. Efectos sobre la reducción del uso de inmunosupresores en el período de inducción.
    5. Perfiles de seguridad, tolerabilidad e inmunogenicidad de las MSV-allo® en los pacientes con NL.
    6. Efectos de MSV-allo® sobre la calidad de vida de los pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Females or males aged ≥ 18 years who give written informed consent at the screening visit.
    2. Systemic Lupus Erythematosus Diagnosis by meeting at least 4 criteria of the 11 included in ACR classification and/or SLICC criteria, at screening visit.
    3. Lupus Nephritis Diagnosis according to 2003 International Society of Nephrology and Renal Pathology Society classification, by biopsy performed no more than 6 months prior to the screening visit if including from the induction period and performed no more than 1 year if including with moderate/severe recurrence.
    4. Non-response or partial response after 3 months of uninterrupted standard induction therapy treatment, or having started induction therapy during the screening period. Or moderate/severe recurrence of lupus nephritis during the maintenance phase.
    5. SLEDAI-2K ≥ 10 during the screening period.
    6. Women of childbearing age must use effective methods of contraception to prevent pregnancy.
    7. Have been vaccinated against pneumococcus and influenza at vaccination campaign time.
    1. Mujeres o varones de ≥ 18 años de edad que den su consentimiento informado por escrito en la visita de selección.
    2. Diagnóstico de LES mediante el cumplimiento de al menos 4 criterios de los 11 incluidos en la clasificación del ACR y/o criterios SLICC, en la visita de selección.
    3. Diagnóstico de NL mediante la clasificación 2003 de la Sociedad Internacional de Nefrología y la Sociedad de Patología Renal, por biopsia realizada no más de 6 meses antes de la visita de selección si entran desde el período de inducción y no más de un año si entran con recidiva moderada/grave.
    4. No respuesta o respuesta parcial, al tratamiento de inducción estándar después de 3 meses de tratamiento ininterrumpido, o haber comenzado con el tratamiento de inducción durante el período de selección. O recidiva moderada/grave de la nefritis lúpica durante la fase de mantenimiento.
    5. SLEDAI-2K ≥ 10 durante el período de selección.
    6. Las mujeres en edad fértil deben utilizar métodos de contracepción efectivos para prevenir el embarazo.
    7. Haberse vacunado contra el neumococo e influenza en el momento que se realice la campaña de vacunación.
    E.4Principal exclusion criteria
    Previous treatments related:
    1. Use of corticosteroids or mycophenolate above allowed doses for induction, according to Systemic Autoimmune Diseases Group of Internal Medicine Spanish Society and Nephrology Spanish Society Consensus Document.
    2. Use of rituximab, belimumab, ocrelizumab or other biological therapies against B cells 6 months prior to screening.
    3. Use of cyclophosphamide at any time during 6 months prior to selection.
    4. Use of any tumor necrosis factor inhibitor therapy at any time during 6 months prior to selection.
    5. Use of immunoglobulins at any time during 6 months prior to selection.
    6. Angiotensin-converting enzyme inhibitor or angiotensin receptor inhibitor dosis change during 2 months prior to selection.
    7. Other investigational agent treatment during three months prior to screening or 5 times agent's half-life.

    Medical conditions related
    1. Any medical condition, including an uncontrolled disease other than SLE, that, in investigator opinion, sponsor or designee, represents an inappropriate risk or trials participation contraindication or would interfere with trial objectives , conduct or evaluation.
    2. Cardiac, peripheral or cerebrovascular cardiovascular episodes during 6 months prior to screening visit.
    3. Active cardiac arrhythmia or significant ECG clinical abnormalities at screening visit or on randomization day which, according to investigator, sponsor, or designee opinion, constitute an inappropriate risk or contraindication to study participation.
    4. Thromboembolic episodes 12 months prior to or at screening visit, whether or not related to associated antiphospholipid syndrome, or inadequate anticoagulation testing 6 weeks immediately prior to or during the screening visit.
    5. Central nervous system SLE active considered severe or progressive (recent or uncontrolled seizures, anticonvulsant therapy changes in the 3 months prior to the screening visit, or leading to significant cognitive impairment).
    6. Diagnosis of any demyelinating disease such as multiple sclerosis or optic neuritis.
    8. Previous or plans for organ transplantation.
    9. Active viral, bacterial or fungal infection clinically significant, or any major episode of infection which required hospitalization or parenteral treatment in 4 weeks prior to the screening visit, during the screening visit, or anti-infective treatment completion in the 2 weeks prior to or during the screening visit, or recurrent infections (three or more same type of infection cases in a period of 12 consecutive months).
    Vaginal candidiasis, onychomycosis and controlled genital or oral herpes simplex virus would not be reasons for exclusion.
    10. History or positive result for human immunodeficiency virus (HIV) test, hepatitis C antibodies and/or polymerase chain reaction, hepatitis B surface antigen (HBsAg+), and/or total IgM antibodies to hepatitis B nuclear antigen at screening.
    11. Diagnosis of active or latent tuberculosis by a purified protein derivative TB skin test (induration ≥ 5 mm) or a positive Quantiferon test result, at screening or 3 months prior to the screening visit. Patients who have completed adequate prior treatment or who are receiving treatment will not repeat the test. Patients who are receiving adequate TB treatment for at least 4 continuous weeks prior to the screening visit and who are expected to complete the treatment regimen will not be excluded.
    12. Presence of class 3 or 4 uncontrolled congestive heart failure according to the New York Heart Association.
    13. Active cancer.
    14. Major surgical intervention within 6 weeks prior to the screening visit or planned during the trial period, including follow-up.
    15. Pregnant or lactating women.

    Laboratory abnormalities
    1. Clinically significant abnormalities in laboratory tests not attributed to active SLE.
    2. Chest X-ray significant abnormalities indicating active TB. The chest x-ray must have been done within 3 months prior to the screening visit or during the screening period.

    Other
    1. Legal incapacity.
    Relacionados con tratamientos previos
    1. Uso de corticoides o micofenolato por encima de las dosis permitidas para la inducción, de acuerdo con el Documento de Consenso del Grupo de Enfermedades Autoinmunes Sistémicas de la Sociedad Española de Medicina Interna y la Sociedad Española de Nefrología.
    2. Uso de rituximab, belimumab, ocrelizumab u otras terapias biológicas contra células B en los 6 meses previos a la selección.
    3. Uso de ciclofosfamida en los 6 meses previos a la selección.
    4. Uso de algún tratamiento inhibidor del factor de necrosis tumoral en los 6 meses previos a la selección.
    5. Uso de inmunoglobulinas en los 6 meses previos a la selección.
    6. Cambio en las dosis de un inhibidor de la enzima convertidora de angiotensina o un inhibidor del receptor de la angiotensina en los dos meses previos a la selección.
    7. Tratamiento con otro agente en investigación en los tres meses previos a la selección o 5 veces la vida media del agente.

    Relacionados con problemas médicos
    1. Toda patología, incluido una enfermedad no controlada diferente al LES, que, en opinión del investigador, del promotor o de la persona que designe, constituya un riesgo inadecuado o una contraindicación para la participación en el ensayo o que pudiera intervenir con los objetivos del ensayo, su realización o su evaluación.
    2. Episodios cardiovasculares cardiacos, periféricos o cerebrovasculares en los 6 meses anteriores a la visita de selección.
    3. Arritmia cardiaca activa o anomalías clínicamente significativas en el ECG en la visita de selección o el día de la aleatorización que, en opinión del investigador, promotor o de la persona que este asigne, constituya un riesgo inadecuado o una contraindicación para la participación en el estudio.
    4. Episodios tromboembólicos en los 12 meses anteriores a la selección o durante la misma, tenga o no que ver con síndrome antifosfolípido asociado, o pruebas de anticoagulación inadecuadas 6 semanas inmediatamente anteriores a la visita de selección o durante la misma.
    5. LES del sistema nervioso central activo que se considere grave o progresivo (crisis convulsivas recientes e incontroladas, cambios en el tratamiento anticonvulsivante en los 3 meses anteriores a la visita de selección o que deriven a un trastorno cognitivo importante).
    6. Antecedentes o diagnóstico actual de alguna enfermedad desmielinizante como la esclerosis múltiple o la neuritis óptica.
    7. Comorbilidades que requieran tratamiento con corticoides sistémicos (oral, rectal o inyectable) como el asma o la enfermedad inflamatoria intestinal.
    8. Antecedentes o planes de trasplante de algún órgano.
    9. Infección vírica, bacteriana o fúngica activa clínicamente significativa, o haber sufrido algún episodio importante de infección que haya requerido hospitalización o tratamiento parenteral en las 4 semanas anteriores a la visita de selección, durante la misma o haber acabado el tratamiento antiinfeccioso en las 2 semanas anteriores a la selección o durante la misma, o antecedentes de infecciones recurrentes (tres o más casos del mismo tipo de infección en un período de 12 meses consecutivos). No sería motivo de exclusión la candidiasis vaginal, la onicomicosis y el virus del herpes simple genital u oral que estén controlados.
    10. Antecedentes o resultado positivo en la prueba del virus de la inmunodeficiencia humana (VIH), anticuerpos de la hepatitis C y/o reacción en cadena de la polimerasa, antígeno de superficie de la hepatitis B (HBsAg+), y/o anticuerpos IgM totales contra el antígeno nuclear de la hepatitis B en la selección.
    11. Diagnóstico de tuberculosis activa o latente mediante una prueba cutánea de TB con derivado proteico purificado (induración ≥ 5 mm) o un resultado positivo en la prueba de Quantiferón, en la selección o en los 3 meses anteriores a la visita de selección. No repetirán la prueba los pacientes que hayan terminado un tratamiento anterior adecuado o que estén recibiendo tratamiento. No se excluirán a los pacientes que estén recibiendo tratamiento adecuado para la TB al menos 4 semanas continuas antes de la visita de selección y que se espera completen la pauta de tratamiento.
    12. Presencia de insuficiencia cardiaca congestiva incontrolada de clases 3 o 4 según la New
    York Heart Association.
    13. Cáncer activo.
    14. Intervención quirúrgica importante en las 6 semanas anteriores de la visita de selección o prevista durante el período del ensayo, incluido el seguimiento.
    15. Mujeres embarazadas o en período de lactancia.

    Anomalías de laboratorio
    1. Anomalías clínicamente significativas en los análisis de laboratorio no atribuidas al LES
    activo.
    2. Radiografía de tórax con alteraciones significativas que indique TB activa. La radiografía de tórax debe haberse realizado en los 3 meses anteriores a la visita de selección o durante el período de selección.

    Otros
    1. Incapacidad legal.
    E.5 End points
    E.5.1Primary end point(s)
    Patients proportion with reduced renal and SLE activity at week 24, compared with placebo.
    Proporción de pacientes con reducción de la actividad renal y del LES en la semana 24, en comparación con placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks after the screening visit.
    Semana 24 tras la visita de selección.
    E.5.2Secondary end point(s)
    1. Patients proportion at week 24 whose prednisone-equivalent corticosteroid dose was reduced relative to the screening visit.
    2. Patients proportion at week 24 whose immunosuppressants dose has been reduced relative to the screening visit.
    3. Reduction by at least 4 points in the SLEDAI-2K index at week 24 after IMP administration.
    4. Time taken to achieve complete remission after IMP administration.
    1. Proporción de pacientes en la semana 24 cuya dosis de corticoides equivalentes a prednisona se haya reducido en relación con la visita de selección.
    2. Proporción de pacientes en la semana 24 cuya dosis de inmunosupresores se haya reducido en relación con la visita de selección.
    3. Reducción en al menos 4 puntos en el índice SLEDAI-2K en las 24 semanas tras administración del PEI.
    4. Tiempo que se tarda en alcanzar la remisión completa después de la administración del PEI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks after the screening visit.
    Semana 24 tras la visita de selección.
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    as protocol
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 20
    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 state20
    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 care
    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 Decision2022-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-24
    P. End of Trial
    P.End of Trial StatusOngoing
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