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    Summary
    EudraCT Number:2018-003856-19
    Sponsor's Protocol Code Number:CVB2018-2
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-10-29
    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 number2018-003856-19
    A.3Full title of the trial
    A Phase I Open Label Study Evaluating the Safety and Feasibility of Allogeneic Mesenchymal stem cells for radiation-induced hyposalivation and xerostomia in previous oropharyngeal patients
    Et open-label studie med undersøgelser af sikkerhed og klinisk anvendelse af allogene mesenkymale stamceller til behandling af stråleinduceret hyposalivation og xerostomi hos patienter med tidligere oropharyngeal cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study evaluating the safety of fat-tissue-derived stem cells from healthy donors as a treatment for dry mouth syndrome after radiotherapy of cancer in the tonsils or base of the tongue.
    Studie med undersøgelser af sikkerhed og anvendelse af donor stamceller til behandling af nedsat spytproduktion og mundtørhed efter strålebehandling for kræft i mundsvælget
    A.4.1Sponsor's protocol code numberCVB2018-2
    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 and Audiology. Rigshospitalet, University Hospital of Cph, DK
    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 organisationDepartment of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet, Denmark
    B.5.2Functional name of contact pointCharlotte Lynggaard
    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 number+4535452370
    B.5.5Fax number+4535452629
    B.5.6E-mailclyn0015@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 nameAllgeneic adipose tissue-derived stromal/stem cells
    D.3.2Product code CSCC_ASC(50)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraglandular use
    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.3.11 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) Yes
    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
    The trial will include participants with Xerostomia ( International Classification of Diseases-10: DQ 838A)
    Studiet vil inkludere forsøgsdeltagere med xerostomi (DQ 838A)
    E.1.1.1Medical condition in easily understood language
    This trial will include participants with dry-mouth syndrome after radiotherapy for cancer in the tonsils or base of the tongue
    Studiet vil inkludere forsøgsdeltagere med mundtørhed opstået efter strålebehandling for kræft i mundsvælget ( kræft i mandlerne eller/og tungerod)
    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 20.0
    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
    The objective is to examine if injection of allogeneic mesenchymal stem cells into the parotid amd submandibular gland is safe and will improve the salivary gland function after radiation-induced damage
    Formålet er at undersøge om donor fedtstamceller er sikre indsprøjte i øre- og kæbespytkirtlerne og om det vil forbedre de store spytkirtlers funktion hos patienter med beskadigelse i disse kirtler sekundært til strålebehandlig for cancer
    E.2.2Secondary objectives of the trial
    Changes in saliva production, changes in quality of life and monitorering immune response to allogeneic stem cell treatment
    Ændring i spytproduktion, ændring i livskvaliteten og registrering af eventuel immun respons på modtagelse af donor stamceller.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Informed consent
    Previous radiotherapy for oropharyngeal OPSCC cancer stage I-II
    2 years of follow-up without recurrence
    Clinically hyposalivation:unstimalted salivary flow < 0.2 ml/min and above 0.05 ml/min
    Grade 1-3 Xerostomia evaluated by UKU side effect rating scale
    Underskrevet informeret samtykke
    Tidligere strålebehandling for planocellulær mundsvælgkræft stadie I-II
    2 års påfølgning uden recidiv
    Klinisk mundtørhed og nedsat spytproduktion fra de store spytkirtler - evalueret ved anerkendte screeningsmetoder
    E.4Principal exclusion criteria
    Any cancer in the previous 2 years ( not including basocellular carcinoma and OPSCC)
    Smoking
    Xerogenic medications
    Any current or previous otjer diseases in the salivary glands ( e.g Sjögrens syndrome, Sialolithiasis)
    Pregancy or planned pregnancy within the next 2 years
    Breastfeeding
    Any other disease/condition juged by the investigator to be grounds for exclusion
    Alle kræftformer de senest 2 år ( fraset mundsvælgkræft og basalcelle hudkræft)
    Medicinsk behandling af mundtørhed
    Medicinsk behandling med mundtørhed som bivirkning
    Andre spytkirtel sygdomme eller tidligere operation
    Graviditet eller planlagt graviditet inden for de næste 2 år
    Igangværende amning
    Anden sygdom som vurderes uhensigtsmæssig i forhold til studiet
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    Change in unstimulated salivary flow rate
    Sikkerhed
    Ændring i ustimuleret spytsekretion
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 1 day, one month and four months
    Efter 1 døgn, 1 måned og 4 måneder
    E.5.2Secondary end point(s)
    Change in quality of life
    Change in salivary gland function
    Immune reponse to allogeneic ASC
    Change in composition of saliva
    Ændring i livskvalitet
    Ændring i de store spytkirtlers funktion
    Immunrespons sekundært til behandling med donor stamceller
    Ændring i spyttets sammensætning
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and blood samples after 1 day, one month and 4 months
    Salivary flow rates after one month and 4 months
    Quality of life questionnaires after 4 months
    Sikkerhed vurderes efter 1 døgn, 1 måned og 4 måneder
    Blodprøver tages efter 1 døgn, 1 måned og 4 måneder
    Livskvalitespørgeskemaer efter 1 måned og 4 måneder
    Spytflow efter 4 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) Yes
    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 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
    Sidste besøg, sidste deltager
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 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 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 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)
    The participants are asked to a clinical evaluation every second year for five years
    Forsøgsdeltagerne vil blive fulgt i 5 år og vil blive indbudt til klinisk opfølgning
    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 Decision2019-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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