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    Summary
    EudraCT Number:2013-003626-88
    Sponsor's Protocol Code Number:HOO-MSC01
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-17
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2013-003626-88
    A.3Full title of the trial
    The utilization of mesenchymal stem cells (MSC) for the treatment of graft versus host disease (GVHD) after allogeneic stem cell transplantation.
    Využití mesenchymálních kmenových buněk (MSC) k léčbě reakce štěpu proti hostiteli (GVHD) po alogenní transplantaci
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The utilization of mesenchymal stem cells (MSC) for the treatment of graft versus host disease (GVHD) after allogeneic stem cell transplantation.
    Využití mesenchymálních kmenových buněk (MSC) k léčbě reakce štěpu proti hostiteli (GVHD) po alogenní transplantaci
    A.3.2Name or abbreviated title of the trial where available
    MSC for the treatment of GVHD after allogeneic stem cell transplantation
    MSC pro léčbu GVHD po alogenní transplantaci
    A.4.1Sponsor's protocol code numberHOO-MSC01
    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 SponsorFakultní nemocnice Plzeň
    B.1.3.4CountryCzech Republic
    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 supportBone Marrow Transplant Foundation
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFakultní nemocnice Plzeň
    B.5.2Functional name of contact pointHematologicko-onkologické oddělení
    B.5.3 Address:
    B.5.3.1Street AddressAlej Svobody 80
    B.5.3.2Town/ cityPlzeň
    B.5.3.3Post code304 60
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420377103 722
    B.5.5Fax number+420377104 623
    B.5.6E-maillysak@fnplzen.cz
    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 namemesenchymal stem cells
    D.3.2Product code MSC
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    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
    The study is intended for patients after allogeneic hematopoietic stem cell transplantation (from related and unrelated donors) with steroid-refractory or steroid-dependent GVHD of any type:
    - Steroid refractory acute GVHD grade II-IV
    - Steroid refractory chronic GVHD
    - Steroid-dependent chronic "late onset" acute GVHD or overlap GVHD
    Studie je určena pro pacienty po alogenní transplantaci hemopoetických kmenových buněk (od příbuzného i nepříbuzného dárce) se steroidně refrakterní či steroidně dependentní GVHD jakéhokoliv typu:
    - steroidně refrakterní akutní GVHD II-IV stupně
    - steroidně refrakterní chronická GVHD
    - steroidně dependentní chronická, „late onset“ akutní či overlap GVHD
    E.1.1.1Medical condition in easily understood language
    Patients after allogeneic hematopoietic stem cell transplantation with steroid-refractory or steroid-dependent GVHD
    Pacienti po alogenní transplantaci kostní dřeně se steroidně refrakterní nebo steroidně dependentní GVHD.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Determine the effect of MSC infusion from unrelated, HLA identical or non-identical donors on steroid refractory or steroid-dependent GVHD of any type
    - Analyze changes in immunological laboratory parameters after the administration of mesenchymal stem cells
    - Stanovit efekt infúze MSC od nepříbuzných, HLA shodných či neshodných dárců na steroid refrakterní či steroidně dependentní GVHD jakéhokoliv typu
    - Analyzovat změny imunologických laboratorních parametrů vzniklé po podání mesenchymálních kmenových buněk
    E.2.2Secondary objectives of the trial
    - Establish the safety of MSC infusion in patients after allogeneic hematopoietic stem cell transplantation
    - Analyze the effect of MSC infusion on the risk of relapse of primary disease
    - Analyze the occurence of infectious complications after infusion of MSC
    - Monitor overall survival after infusion of MSC
    - Monitor quality of life after the MSC
    - Observe the dose of corticosteroids
    - Stanovit bezpečnost infúze MSC pacientům po alogenní transplantaci krvetvorných buněk
    - Sledovat vliv infúze MSC na riziko relapsu základní nemoci
    - Sledovat výskyt infekčních komplikací po infúzi MSC
    - Sledovat celkové přežití po infúzí MSC
    - Sledovat kvalitu života po podání MSC
    - Sledovat dávku kortikosteroidů
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for patients:
    - Age 18-70 years
    - A signed informed consent
    - Status after allogeneic HSCT complicated with GVHD (any type) with effective levels of CsA (min 150 ng/ml) and:
    a) no response to corticosteroids at a minimum dose of 1mg/kg administered for at least 2 weeks
    or
    b) GVHD progressing during the abovementioned treatment
    or
    c) corticosteroid-dependent GVHD , ie, GVHD responding to corticosteroids, but with the necessity of continuous administration of a minimum dose of 0.1 mg Medrol/kg/day (or equivalent)
    or
    d) GVHD permanently requiring combination of ciclosporin and another immunosuppressant (eg. MMF etc.), while steroids are from any reason contraindicated or not tolerated

    Inclusion criteria for donors:
    - A signed informed consent
    - Negativity for infectious disease markers according to the standard requirements (SÚKL, JACIE, WMDA)
    Vstupní kritéria pro pacienty:
    - věk 18 – 70 let
    - podepsaný informovaný souhlas
    - stav po alogenní TKB jakéhokoliv komplikované GVHD (jakékoliv typu) s účinnými hladina CsA (min 150 ng/ml) a:
    a) bez odpovědi na kortikoidy v minimální dávce 1mg/kg podávané po dobu alespoň 2 týdnů
    nebo
    b) s GVHD progredující při výše zmíněné léčbě
    nebo
    c) s GVHD kortikoid dependentní, tj. s odpovědí na kortikoidy, ale s nutností jejich trvalého podávání v minimální dávce 0,1 mg Medrolu/kg/den (či ekvivalent)
    nebo
    d) s GVHD trvale vyžadující kromě cyklosporinu současně ještě další imunosupresivum (např. MMF apod.), přičemž kortikoidy jsou z jakéhokoliv důvodů kontraindikované či netolerované

    vstupní kritéria pro dárce:
    - podepsaný informovaný souhlas
    - negativita infekčních markerů dle standardních požadavků (SÚKL, JACIE, WMDA)
    E.4Principal exclusion criteria
    Exclusion criteria for patients:
    - poor performance status with expected survival < week
    - treatment with extracorporeal phohotopheresis (ECP) in less than 3 months
    - active uncontrolled infection of any type
    - the assumption of non-compliance
    - activity (progression) of the primary disease

    The exclusion criteria for donors:
    - age> 65 years
    - positive testing for infectious diseases markers
    Vylučující kritéria pro pacienty:
    - špatný celkový stav s předpokládaným přežitím < týden
    - léčba extrakorporální fotoreferezou (ECP) v době kratší než jsou 3 měsíce
    - aktivní nekontrolovaná infekce jakéhokoliv typu
    - předpoklad nedostatečné spolupráce
    - aktivita (progrese) základního onemocnění

    Vylučující kritéria pro dárce:
    - věk > 65 let
    - pozitivita infekčních markerů
    E.5 End points
    E.5.1Primary end point(s)
    - relieve the symptoms of GVHD - achieving complete or partial clinical response according to the consensus criteria
    - reduction of pro-inflammatory immunological laboratory parameters
    - absence of relapse of primary disease
    - zmírnění symptomů GVHD- dosažení kompletní nebo parciální klinické odpovědi dle konsensuálních kritérií
    - snížení prozánětlivých imunologických laboratorních parametrů
    - absence relapsu základního nádorového onemocnění
    E.5.1.1Timepoint(s) of evaluation of this end point
    The evaluation will be performed before the application of MSC and then 14 days, 30 days, 60 days, 100 days, 6 months and 12 months after after the treatment.
    Hodnocení bude provedeno před aplikací MSC a poté za 14 dnů, 30 dnů, 60 dnů, 100 dnů, 6 měsíců a 12 měsíců po léčbě.
    E.5.2Secondary end point(s)
    - improving the quality of life of patients (standardized questionnaire)
    - reduction of the dose of corticosteroids
    - zlepšení kvality života pacientů (standardizovaný dotazník)
    - snížení dávky kortikosteroidů
    E.5.2.1Timepoint(s) of evaluation of this end point
    The evaluation will be performed before the application of MSC and then 30 days, 100 days and 12 months after after the treatment.
    Hodnocení bude provedeno před aplikací MSC a poté za 30 dnů, 100 dnů a 12 měsíců po léčbě.
    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.8.3 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
    Studie bude ukončena po dokončení sledování posledního zařazeného pacienta.
    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 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: 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 state25
    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
    žádné
    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 Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-10
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