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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   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:2020-002804-38
    Sponsor's Protocol Code Number:AMASS
    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:2020-06-16
    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 number2020-002804-38
    A.3Full title of the trial
    A randomized clinical trial evaluating allogeneic adipose-derived mesenchymal stem cells as a treatment of dry eye disease in Sjögren's Syndrome
    Et randomiseret klinsk forsøg med undersøgelse af allogene mesenkymale stamceller som en behandling af tørre øjne hos Sjøgrens syndrom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial in which treatment with stem cells derived from adipose-tissue of healthy donors is tested in patients with reduced tear production due to Sjögren's Syndrome
    Et klinisk forsøg, hvor behandling med stamceller fra fedtvæv fra sunde donorer testes hos patienter med nedsat tåreproduktion på grund af Sjøgrens syndrom
    A.3.2Name or abbreviated title of the trial where available
    AMASS
    AMASS
    A.4.1Sponsor's protocol code numberAMASS
    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-Glostrup
    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 supportThe Synoptik foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Fight for Sight
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Ophtalmology, RigshospitaletGlostrup
    B.5.2Functional name of contact pointMichael Møller-Hansen
    B.5.3 Address:
    B.5.3.1Street AddressNordre Ringvej 57
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4593901230
    B.5.6E-mailmichael.moeller-hansen@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 tissue-derived stromal/stem cells
    D.3.2Product code CSCC_ASC(22)
    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 INNCSCC_ASC(22)
    D.3.9.3Other descriptive nameALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED
    D.3.9.4EV Substance CodeSUB181445
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntraglandular use
    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 Aqueous Deficient Dry Eye Disease due to Sjögrens syndrom (International Classification of Diseases-10: DM 350A)
    E.1.1.1Medical condition in easily understood language
    Sjögren's syndrome can cause Aqueous Deficient Dry Eye Disease which is a condition in which the tear production in the lacrimal gland is impaired.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023350
    E.1.2Term Keratoconjunctivitis sicca
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Our objective is to assess the efficacy of allogeneic adipose-tissue derived mesenchymal stem cells (ASCs) administered for lacrimal
    gland hypofunction in patients with ADDE due to Sjögren's syndrome
    E.2.2Secondary objectives of the trial
    Our secondary objective is to assess whether injection of allogeneic ASCs results in any adverse reactions to the IMP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age > 18 years
    Diagnosis of Sjögren’s syndrome according to the 2016 American College of Rheumatology/European League Against Rheumatism classification criteria for primary Sjögren's syndrome
    OSDI-score ≥ 33
    Schirmer’s test 1-5 mm/5 minutes
    NIKBUT < 10 sec
    E.4Principal exclusion criteria
    Lacrimal gland volume on MRI < 0,2 cm3 in the study eye
    Previous treatment with ASCs or other stem cell products in the lacrimal gland(s)
    Reduced immune response (e.g. HIV positive)
    Pregnancy or planned pregnancy within the next 2 years
    Breastfeeding
    Topical treatment with eye drops other than to treat dry eye diease
    Any other disease/condition judged by the investigator to be grounds for exclusion, such as infection in or around the eye
    E.5 End points
    E.5.1Primary end point(s)
    Change in OSDI-score
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 week, 4 weeks, 4 months and 12 months after treatment
    E.5.2Secondary end point(s)
    The secondary endpoints are change in TMH and NIKBUT-first using the K5M, change in tear production as evaluated with the Schirmer’s I test, change in tear osmolarity, and change in ocular surface staining evaluated with the Oxford score. All adverse events (AEs) and severe adverse events (SAEs) will be recorded and graded according to Common Terminology Criteria for Adverse Events (CTCAE).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 week, 4 weeks, 4 months and 12 months after treatment
    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 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 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
    Last participant's last visit 12 months after treatment
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    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)
    None
    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 Decision2020-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-28
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