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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-000348-24
    Sponsor's Protocol Code Number:CVB2018-1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-000348-24
    A.3Full title of the trial
    Mesenchymal stem cells for radiation-induced hyposalivation and xerostomia in previous head and neck cancer patients (MESRIX-II)
    Mesenkymale stamceller til behandling af stråleinduceret hyposalivation og xerostomi hos patienter med tidligere hovedhalskræft
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stem cell treatment of dry mouth after radiation therapy of head and neck cancer
    Stamceller til behandling af nedsat spytproduktion og mundtørhed efter strålebehandling for kræft i hovedhalsområdet
    A.3.2Name or abbreviated title of the trial where available
    MESRIX_III
    A.4.1Sponsor's protocol code numberCVB2018-1
    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 SponsorDepartment of Otorhinolaryngology, Head and Neck Surgery
    B.1.3.4CountryDenmark
    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 supportCandys Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
    B.5.2Functional name of contact pointChristian Von Buchwald
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9, section 2071
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004535452370
    B.5.5Fax number004535452629
    B.5.6E-mailchristian.von.buchwald@regionh.dk
    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 mesenchymal stem cells/ aMSCs/ASCs
    D.3.4Pharmaceutical form Living tissue equivalent
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    Other use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEXPANDED HUMAN ALLOGENEIC MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE
    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 million organisms million organisms
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboOther use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The trial will include participants with Xerostomia (International Classification of Diseases-10: DQ 838A) who have been treated with raditherapy for a head and neck cancer prevoiusly.
    Studiet vil inkludere forsøgsdeltagere med xerostomi (DQ 838A) efter tidligere strålebahandling af en hovedhalskræft.
    E.1.1.1Medical condition in easily understood language
    This trial will include participants with dry-mouth after radiation therapy and head and neck cancer.
    Studiet vil inkludere deltagere med mundtørhed efter strålebehandling for hovedhalskræft.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10013781
    E.1.2Term Dry mouth
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10039420
    E.1.2Term Salivary gland therapeutic procedures
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10039404
    E.1.2Term Salivary gland conditions
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10039390
    E.1.2Term Salivary gland atrophy
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective is to examine whether enrichment of the submandibular glands with injections of allogeneic ASCs will improve the salivary function in radiation-induced salivary damage.
    Formålet er at undersøge om donor fedtstamceller kan forbedre funktion af spytkirler, der er blevet beskadiget i forbindelse med strålebehandling for hovedhalskræft.
    E.2.2Secondary objectives of the trial
    Screening of changes in quality of life and immune response secondary to treatment with allogeneic adipose-derived mesenchymal stem cells. Further the objective is to investigate whether repeated treatment witj allogenic ASCs is better than a single treatment.
    Screening af ændringer i livskvaliteten og screening ændringer i recipientens immunforsvar secondært til behandling med allogene fedt-deriverede mesekymale stamceller. Formålet er desuden at undersøge om gentagen behandling med donorstamceller har bedre effekt på spytkirtelfunktionen end en enkelt behandling.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Repeated treatmen with ASCs in patients who have previously received ASCs as part of MESRIX-I, MESRIX-II or MESRIX-III.
    The objective is to investigate whether repeated treatment witj allogenic ASCs is better than a single treatment.
    Inclusion criteria:
    1. Previous treatment with ASCs in the salivary glands as part of MESRIX-I, MESRIX-II or MESRIX-III.
    2. WHO Performance status (PS) 0-1 64
    3. Age between 18-75 years
    4. 2 years’ follow-up for their head and neck cancer without recurrence
    5. Informed consent.


    Additional exclusion criteria:
    1. Development of HLA antibodies after previous treatment with ASCs in the salivary glands as part of MESRIX-I, MESRIX-II or MESRIX-III.
    Gentagen behandling med fedt-deriverede mesenkymale stamceller til patienter som tidligere har modtaget stamceller som led i MESRIX-I, MESRIX-II eller MESRIX-III. Formålet er at undersøge om gentagen behandling med donorstamceller har bedre effekt på spytkirtelfunktionen end en enkelt behandling.
    Inklusionskriterier.
    1. tidligere behandling med ASCs i MESRIX-I, MESRIX-II or MESRIX-III.
    2. WHO Performance status (PS) 0-1
    3. Alder mellem 18-75 år
    4. 2 års follow up uden recidiv
    5. informeret samtykke

    Ekstra eksklusionkrietrium:
    1. udvikling af HLA antistoffer efter tidligere behandling med ASCs i MESRIX-I, MESRIX-II or MESRIX-III.
    E.3Principal inclusion criteria
    Previous radiotherapy for head and neck cancer
    2 years follow-up without recurrence
    Clinically hyposalivation: unstimulated salivary flow < 0.2ml /ml and above 0.05 ml/min
    Informed consent
    Grade 1-3 Xerostomia evaluated by the UKU side effect rating scale
    Age 18-75
    WHO performance score 0-1
    Tidligere strålebehandling for hovedhalskræft
    2 års opfølgning uden recidiv
    Klinisk mundtørhed og nedsat funktion af de store spytkirtler-evalueret ved anerkendt screeningsmetode: unstimuleret spyt flow < 0.2ml /ml og > 0.05 ml/min
    Informeret samtykke underskrevet
    Alder 18-75
    WHO performance score 0-1
    E.4Principal exclusion criteria
    Any cancer in the previous 2 years ( not including OPSCC and basocellular carcinoma)
    Smoking within the last 6 months
    Xerogenic medications within the last 3 months
    Any current or previous other diseases in the salivary glands (Sjögrens syndrome, Sialolithiasis etc.)
    Pregnancy or planned pregnancy with the next 2 years
    Breastfeeding
    Any other disease/condition juged by the investigator to be grounds for exclusion
    Kræft af hvilken som helst type de seneste 2 år ( fraset mundsvælgkræft og basalcellehudkræft)
    Medicinsk behandling af mundtørhed
    Andre spytkirtel sygdomme eller tidligere operation på spytkirtlerne
    Graviditet eller planlagt graviditet inden for de næste 2 år
    Igangværende amning
    Anden sygdom som vurderes uhensigtsmæssigt i forhold til risici
    E.5 End points
    E.5.1Primary end point(s)
    Change in unstimulated salivary flow rate
    Ændring i ustimuleret spytsekretion
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 months and 12 months after intervention
    Ændring efter 4 og 12 måneder efter intervention
    E.5.2Secondary end point(s)
    1. Safety
    2. Change in quality of life.
    3. Change in saliva flow rate assessed by sialometri
    4. Immune response to allogeneic ASC.
    5. Change in the composition of saliva
    6. Change in salivary gland function at four months, 1 year and 2 years after repeated treatment, measured by an increase in unstimulated and stimulated whole SFR.
    7. Change in quality of life after repeated treatment. Evaluated by a decrease in complaints of xerostomia as evaluated by two patient questionnaires (EORTC QLQ Module for H&N-35and XQ) at four months, 1 year and 2 years.
    8. Change in the composition of saliva after four months, 1 year and 2 years after repeated treatment.
    1. Sikkerhed
    2. Ændring i livskvalitet
    3. Ændirng i spytproduktionen målt ved sialometri
    4. Immunrespons sekondært til behandling med allogene fedt-derivederede stamceller
    5. Ændring i spyttets sammensætning (spyttets kvalitet)
    6. Ændring i spytkirtel funktion efter gentagen behandling med stamceller efter 4 måneder, 1 år og 2 år.
    7. Ændring i livskvalitet efter gentagen behandling. Vurderes ved et fald i klager vedrørende xerostomi i spørgeskemaerne EORTC QLQ Module for H&N-35and XQ efter 4 måender, 1 år og 2 år.
    8. Ændring i spytsammensætningen efter gentagen behandling målt efter 4 måneder, 1 åt og 2 år.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples 4 and 12 months after intervention. For repeated treatment also after 24 months.
    Quality of life questionnaires after 4 and 12 months after intervention. For repeated treatment also after 24 months.
    Sialometri after 4 and 12 months after intervention. For repeated treatment also after 24 months.
    Blodprøver 4 og 12 måneder efter intervention. For gentagen behandling også efter 24 måneder.
    Livskvalitetsspørgeskemaer 4 og 12 måneder efter intervention. For gentagen behandling også efter 24 måneder.
    Sialometri 4 og 12 måneder efter intervention.For gentagen behandling også efter 24 måneder.
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    For delstudie vedr gentagen behandling er der ikke nogen blinding, radnomisering eller placebokontro
    For sub-study adressing repeated treatment there is no blinding, randomization or placebo-control.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    For delstudie vedr gentagen behandling er der ikke nogen blinding, radnomisering eller placebokontro
    For sub-study adressing repeated treatment there is no blinding, randomization or placebo-control.
    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 visit last subject
    Sidst besøg, sidste deltager
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 80
    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 state120
    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)
    The participants have yearly/ 2-yearly checks at the oncologic department
    Forsøgspatienterne kommer til årlige/ hvert andet år til ambulant opfølgningpå onkogisk afdeling
    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 Decision2018-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-22
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