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    Summary
    EudraCT Number:2018-001720-19
    Sponsor's Protocol Code Number:XRS-ITRT-2018
    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:2018-11-23
    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 number2018-001720-19
    A.3Full title of the trial
    Phase II clinical trial to evaluate the effect and safety of MSV * in Xerostomia
    * adult autologous bone marrow mesenchymal stem cells, expanded under GMP of IBGM
    Ensayo clínico fase II para evaluar el efecto y la seguridad de las MSV* en Xerostomía
    *células mesenquimales troncales adultas de médula ósea autóloga, expandidas bajo NCF del IBGM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II clinical trial to evaluate the effect and safety of MSV * in Xerostomia
    * adult autologous bone marrow mesenchymal stem cells
    Ensayo clínico fase II para evaluar el efecto y la seguridad de las MSV* en Xerostomía
    *células mesenquimales troncales adultas de médula ósea autóloga
    A.3.2Name or abbreviated title of the trial where available
    Xerostomia
    Xerostomia
    A.4.1Sponsor's protocol code numberXRS-ITRT-2018
    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 SponsorInstitut de Terapia Regenerativa Tissular S.L. (ITRT)
    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 supportInstitut de Terapia Regenerativa Tissular S.L. (ITRT)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Terapia Regenerativa Tissular S.L.
    B.5.2Functional name of contact pointProject Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressC/ Vilana 12
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08022
    B.5.3.4CountrySvalbard and Jan Mayen
    B.5.4Telephone number+34-932906042
    B.5.5Fax number+34 93 290 6041
    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 nameMSV -células progenitoras mesenquimales de médula ósea autóloga expandidas con procedimientos GMP
    D.3.4Pharmaceutical form Living tissue equivalent
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMSV-CMT
    D.3.9.3Other descriptive nameEX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3300000
    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
    Xerostomia post radiotherapy
    Xerostomía post radioterapia
    E.1.1.1Medical condition in easily understood language
    Xerostomia post radiotherapy
    Xerostomía post radioterapia
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10048223
    E.1.2Term Xerostomia
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Determine changes in the xerostomia characteristics and discomfort degree by means of questionnaires addressed to the physician and subject of study.
    - Determine the volume of submaxilar saliva without stimulation and with stimulation by sialometry (SL).
    - Detect changes in volume, vascularization and fibrosis of submaxillary glands based on magnetic resonance imaging (MRI) with contrast.
    - Detect changes of submaxillary gland functionalism based on Gammagraphy (GF).
    - Determinar cambios en las características y grado de molestias de xerostomía mediante cuestionarios dirigidos a médico y sujeto de estudio.
    - Determinar el volumen de la saliva submaxilar sin estimulación y con estimulación mediante sialometría (SL).
    - Detectar cambios de volumen, vascularización y fibrosis de glándulas submaxilares basadas en la proyección de imagen de resonancia magnética (RMN) con contraste.
    - Detectar cambios de funcionalismo de glándulas submaxilares basados en Gammagrafía (GF).
    E.2.2Secondary objectives of the trial
    - Determine the Safety of the proposed procedure by recording adverse events (AEs) and serious adverse events (SAEs).
    - Determinar la Seguridad del procedimiento propuesto registrando los acontecimientos adversos (AAs) y acontecimientos adversos graves (AAGs).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients from 18 to 75 years old of both sexes.
    2. Biochemical analysis without significant alterations which could contraindicate the treatment.
    3. Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a.
    4. 2 years of follow-up without recurrence.
    5. Reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0.05-0.20 ml / min.
    6. Grade 1-3 xerostomy as assessed by the grading scale.
    7. The patient is able to understand the nature of the study.
    8. Written informed consent of the patient
    1. Pacientes de 18 a 75 años de ambos sexos.
    2. Análisis bioquímicos sin alteraciones significativas que contraindiquen el tratamiento.
    3. Radioterapia bilateral del cuello previa por neoplasia en estados T1-T2 y N0, N1 y N2a.
    4. 2 años de seguimiento sin recidiva.
    5. Reducción de la salivación y la hiposalivación, evaluados por un examen, tasa de flujo o saliva entera sin estimular en el rango de 0.05-0.20 ml/min.
    6. Grado 1-3 xerostomía según lo evaluado por la escala de calificación.
    7. El paciente es capaz de entender la naturaleza del estudio.
    8. Consentimiento informado por escrito del paciente
    E.4Principal exclusion criteria
    1. Participation in another clinical trial in the 3 months prior to his/her inclusion.
    2. Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
    3. Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
    4. History of cancer in the last 2 years. History of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa.
    5. Xerogenic medication in progress.
    6. Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc.
    7. Local infection.
    8. Pregnancy or pregnancy planned within the next 2 years.
    9. Breastfeeding.
    10. Treatment with anticoagulants (not interruptible in MO or application).
    11. Any other illness or condition that is grounds for exclusion for the investigator.
    1. Participación en otro ensayo clínico en los 3 meses previos a su inclusión.
    2. Infección presente (no debe evidenciarse ningún signo infeccioso con repercusión sobre la evolución de la lesión tratada).
    3. Pacientes con serologías positivas para HIV, lúes y hepatitis con carga viral positiva.
    4. Antecedente de cáncer en los últimos 2 años. Antecedente de teratoma, adenocarcinoma derivado de una de las dos glándulas salivales, linfoma de las amígdalas o de algún otro tejido linfático o melanoma de células pigmentadas de la mucosa oral.
    5. Medicación xerogénica en curso.
    6. Otras enfermedades de las glándulas salivales, por ejemplo, síndrome de Sjögren, sialolitiasis, etcétera.
    7. Infección local.
    8. Embarazo o embarazo previsto dentro de los próximos 2 años.
    9. Lactancia materna.
    10. Tratamiento con anticoagulantes (no interrumpible en MO o aplicación).
    11. Cualquier otra enfermedad o condición que para el investigador sea motivo de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    - Changes in the OHIP Questionnaire (OHIP-14-sp) and EVA of xerostomia to determine the changes in the characteristics and degree of discomfort of xerostomia.
    - Restoration or increase of salivary function to determine the volume of submaxilla saliva without stimulation and with stimulation (sialometry).
    - Restoration of the glandular structure (volume, vascularization and fibrosis of submaxillary glands) by means of NMR with contrast that denote changes in its volume and fibrosis.
    - Measurement of submaxillary gland functionalism changes through gammagraphy.
    - Cambios en el Cuestionario OHIP (OHIP-14-sp) y EVA de xerostomia para determinar los cambios en las características y grado de molestias de xerostomía.
    - Restauración o aumento de la función salival para determinar el volumen de la saliva submaxilar sin estimulación y con estimulación (sialometría).
    - Restauración de la estructura glandular (volumen, vascularización y fibrosis de glándulas submaxilares) mediante RMN con contraste que denote cambios en su volumen y fibrosis.
    - Medición de cambios de funcionalismo de glándulas submaxilares mediante Gammagrafía.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months + 12 months for safety (outside the clinical trial)
    12 meses + 12 meses por seguridad (fuera del ensayo clínico)
    E.5.2Secondary end point(s)
    Determination of the Safety of the proposed procedure, recording adverse events (AEs) and serious adverse events (SAEs).
    It will be considered as early safety measures: Pain at the site of injection, submaxillary swelling, duration of submaxillary swelling in days, oral discomfort, infection.
    Determinación de la Seguridad del procedimiento propuesto, registrando los acontecimientos adversos (AAs) y acontecimientos adversos graves (AAGs).
    Se contemplará como medidas de seguridad temprana: Dolor en el sitio de la inyección, Tumefacción submaxilar, Tiempo de duración de la tumefacción submaxilar en días, Molestias orales, Infección.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months + 12 months for safety (outside the clinical trial)
    12 meses + 12 meses por seguridad (fuera del ensayo clínico)
    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 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.8.2.4Number of treatment arms in the trial1
    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
    Last patient last visit (LPLV)
    Último paciente última visita (LPLV)
    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 months12
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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)
    According normal clinical practice
    Acorde práctica clínica habitual
    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 Decision2018-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-25
    P. End of Trial
    P.End of Trial StatusOngoing
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