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    The EU Clinical Trials Register currently displays   43602   clinical trials with a EudraCT protocol, of which   7206   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:2014-004349-29
    Sponsor's Protocol Code Number:01-10-2014
    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:2015-02-04
    Trial results View 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 number2014-004349-29
    A.3Full title of the trial
    Mesenchymal stem cells for radiation-induced xerostomia (MESRIX) in previous HPV-positive oropharyngeal head and neck cancer patients
    Mesenkymale stamceller til behandling af stråleinduceret xerostomi hos tidligere HPV-positive oropharyngeale hoved hals cancer patienter - Et sikkerhedsstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stemcell treatment of drymouth after radiation therapy of HPV induced cancer in the tonsils or base of tongue
    Stamcelle behandling af mundtørhed efter strålebehandlet HPV- positiv svælgkræft
    A.3.2Name or abbreviated title of the trial where available
    MESRIX
    A.4.1Sponsor's protocol code number01-10-2014
    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 SponsorRigshospitalet
    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 supportCandy Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept. of Otolaryngology, Head and Neck surgery
    B.5.2Functional name of contact pointRigshospitalet
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004535452071
    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 nameAutologous adipose-derived stem cells / Mesenchymale stem cells (MSC)
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    Route of administration not applicable
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEXPANDED HUMAN AUTOLOGOUS MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE
    D.3.9.3Other descriptive nameEXPANDED HUMAN AUTOLOGOUS MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE (EASCS)
    D.3.9.4EV Substance CodeSUB30158
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number-10 to +10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIsotonic NaCl
    D.3.9.3Other descriptive nameSTERILE PYROGEN-FREE ISOTONIC NACL SOLUTE (0.9% W / V)
    D.3.9.4EV Substance CodeSUB79490
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Albumin
    D.3.9.1CAS number 8000043-98-3
    D.3.9.3Other descriptive nameALBUMIN HUMAN SALT-POOR
    D.3.9.4EV Substance CodeSUB12761MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 study will include participants with xerostomi (International
    Classification of Diseases-10: DQ 838A) and oropharyngeal cancer (DC 10).
    Studiet vil inkl. forsøgsdeltagere med xerostomi (DQ 838A) og oropharyngeal cancer (DC10)
    E.1.1.1Medical condition in easily understood language
    This study will include participants with dry-mouth after radiation therapy of cancer in the tonsils and base of tongue.
    Studiet vil inkludere deltagere med mundtørhed og kræft i mundsvælget (mandlerne og tungeroden).
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10031103
    E.1.2Term Oropharyngeal cancer stage unspecified
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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
    The objective is to examine whether enrichment of the submandibular gland with injection of autologous ASC will improve the result of salivary function in radiation-induced gland hypofunction.
    Formålet er et undersøge hvorvidt stamcelle behandling af mundtørhed efter strålebehandling forbedrer spytkirtlens funktion.
    E.2.2Secondary objectives of the trial
    Screening of radiological and histological changes in the gland after stem cell-enriched fat injection as based on MRI and biopsy.
    Screening af radiologiske og histologiske ændringer i kirtlen efter stamcelle-behandling vurderet ved MRI og biopsi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Previous radiotherapy for HPV-positive oropharyngeal head and neck cancer with bilateral irradiation of the neck.
    • 2 years follow-up without recurrence
    • Clinically reduced hyposalivation and hyposalivation, evaluated by a screening
    o Unstimulated salivary flow rate between less than 0.2ml/min and above 0.05ml/min
    • Only participants with previous T1-T2 and N0, N1 or N2a.
    • Informed consent
    • Grade 1-43 xerostomia as evaluated by the UKU side effect rating scale
    Tidligere strålebehandlet for HPV-positiv svælgkræft, T1-T2 og N0, N1 eller N2a.
    2 års opfølgning uden recidiv
    Klinisk mundtørhed og nedsat spytsekretion evalueret ved anerkendt screeningsmetode.
    Informeret samtykke underskrevet
    E.4Principal exclusion criteria
    • Any cancer in the previous 2 years
    • Xerogenic medications
    • Any previous other diseases in of the salivary glands, e.g. Sjögrens syndrome, sialolithiasis, etc.
    • Pregnancy or planned pregnancy within the next 2 years
    • Breastfeeding
    • Any other disease/condition judged by the investigator to be grounds for exclusion
    • Treatment with anticoagulant that cannot be stopped during the intervention period.
    Hvilken som helst kræft de sidste 2 år.
    Medicinsk behandling af mundtørhed
    Andre sygdomme i spytkirtlerne Sjögrens, sialolithiasis, etc.
    Gravid eller planlagt graviditet de næste 2 år
    Igangværende amning
    Anden sygdom som vurderes uhensigtsmæssig ift mulige risici (f.eks. svære immunologiske sygdomme, svær hjerte/ lunge syg)
    Antikoagulant behandling som ikke kan pauseres.
    E.5 End points
    E.5.1Primary end point(s)
    • Safety
    All measures of adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) [26]. Since this is a local treatment with MSCs the primary safety measures are:
    • Pain at injection site (Grade 1: Mild pain, grade 2: Moderate pain; limiting instrumental activities of daily living (ADL), grade 3: Severe pain; limiting self care ADL)
    • Oral discomfort (Grade 1: Mild discomfort; not interfering with oral intake, grade 2: Moderate pain; interfering with oral intake, 3: Disabling pain; tube feeding or TPN indicated)
    • Infection (Grade 1: Localized; local intervention indicated, grade 2: Oral intervention indicated (antibiotic, antifungal, antiviral), grade 3: IV antibiotic, antifungal or antiviral indicated; or radiologic, endoscopic or operative intervention indicated, grade 4: life threatening consequences; urgent intervention needed)
    • Sikkerhed
    Alle foranstaltninger af uønskede hændelser vil blive gradueret i henhold til en fælles terminologi Kriterier for bivirkninger (CTCAE) [26]. Da dette er en lokal behandling med MSC'er de primære sikkerhedsforanstaltninger er:
    • Smerter på injektionsstedet (Grad 1: Mild smerte, grad 2: Moderat smerte, begrænsning instrumentale dagligdags aktiviteter (ADL), grad 3: Svære smerter, begrænsning af egenomsorg ADL)
    • Oral ubehag (Grad 1: Mild ubehag, ikke interfererer med oral indtagelse, klasse 2: Moderat smerte; forstyrre oral indtagelse, 3: Deaktivering smerte, sondeernæring eller TPN angivet)
    • Infektion (Grad 1: Lokaliseret; lokale interventioner angivet, klasse 2: Oral medicin ngivet (antibiotika, svampedræbende, antiviral), grad 3: IV antibiotika, svampedræbende eller antiviral angivet; eller radiologisk, endoskopisk eller operative indgreb angivet, klasse 4: life truende konsekvenser hasteindgreb nødvendigt)
    E.5.1.1Timepoint(s) of evaluation of this end point
    3-4 weeks and 3-4 months after intervention.
    3-4 uger og 3-4 måneder efter intervention.
    E.5.2Secondary end point(s)
    • Significant increase in unstimulated and stimulated whole saliva flow rate in the group receiving MSCs, compared with the group of participants receiving placebo (control group). Salivary flow rate will be calculated as a change in the participant's saliva flow rate from before intervention (baseline) to four months after.
    • Significant decrease in complaints of xerostomia in the group receiving MSCs compared with the group of participants receiving placebo as evaluated by a physician and patient questionnaire.
    • Measurement of 4-months volume change of submandibular glands based on magnetic resonance imaging (MRI). Calculated as a change after 4 months compared to MRI before intervention (baseline).
    Registration of all unexpected side effects of the intervention.
    • Estimation of change in the amount of fibrosis from the MRI-scan between intervention and placebo group.
    • Estimation of the change in the amount of serous and mucinous gland tissue in histological sections from the biopsies taken pre- (baseline) and post-interventional.
    • Estimation in the change in fibrosis in histological sections from the biopsies taken pre- (baseline) and post-interventional.
    • Estimation in the change in vascularisation in histological sections from the biopsies taken pre- (baseline) and post-interventional.
    • Betydelig stigning i ikke-stimulerede og stimuleret hele spyt flow i gruppen, der fik MSC'er sammenlignet med gruppen af deltagere, der fik placebo (kontrolgruppe). Spyt flow vil blive beregnet som en ændring i deltagerens spyt flow fra før intervention (baseline) til fire måneder efter.
    • Signifikant fald i klager over xerostomi i gruppen, der modtog MSC'er sammenlignet med gruppen af deltagere, der fik placebo som vurderes af en læge og patient spørgeskema.
    • Måling af 4-måneders volumen ændring af submandibulære kirtler baseret på magnetisk resonans (MRI). Beregnet som en ændring efter 4 måneder sammenlignet med MRI før intervention (baseline).
    Registrering af alle uventede bivirkninger af interventionen.
    • Beregning af ændring i mængden af fibrose fra MR-scanning mellem intervention og placebogruppen.
    • Estimering af ændring i mængden af serøs og mucinous kirtel væv i histologiske snit fra biopsier er taget før (baseline) og post-interventionel.
    • Estimation i forandringen i fibrose i histologiske snit fra biopsier er taget før (baseline) og post-interventionel.
    • Skøn af ændringen i vaskularisering i histologiske snit fra biopsier er taget før (baseline) og post-interventionel.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Biopsy and MRI: 3-4 weeks and 3-4 months after intervention.
    Biopsi og MRI: 3-4 uger og 3-4 måneder after intervention.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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
    LVLS
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 30
    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 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 state30
    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.
    Forsøgsdeltagerne kommer til årlige / hvert andet års ambulante besøg på onkologisk klinik.
    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 Decision2015-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-07
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