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    Summary
    EudraCT Number:2015-001560-19
    Sponsor's Protocol Code Number:CSCC-ASC2
    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:2015-05-12
    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 number2015-001560-19
    A.3Full title of the trial
    Allogeneic adipose tissue-derived stromal/stem cell therapy in patients with ischemic heart disease and heart failure
    Allogen fedtvævs-deriverede stromal/stamcelle behandling af patienter med hjertesvigt
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stem cell therapy in heart failure
    Stamcellebehandling ved hjertesvigt
    A.3.2Name or abbreviated title of the trial where available
    CSCC_ASC2
    CSCC_ASC2
    A.4.1Sponsor's protocol code numberCSCC-ASC2
    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 Cardiology, Rigshospitalet
    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 supportRigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Cardiology, 2014, Rigshospitalet
    B.5.2Functional name of contact pointJens Kastrup
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen OE
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004535452819
    B.5.5Fax number004535452705
    B.5.6E-mailjens.kastrup@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.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 cell
    D.3.2Product code CSCC_ASC
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracardiac use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCSCC_ASC
    D.3.9.2Current sponsor codeCSCC_ASC2
    D.3.9.3Other descriptive nameEX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS
    D.3.10 Strength
    D.3.10.3Concentration number100 mill
    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 placeboIntracardiac use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ischemic heart disease and heart failure
    Kranspulsåresygdom og hjertesvigt
    E.1.1.1Medical condition in easily understood language
    Patients with heart failure have reduced cardiac pump function, physical functional capacity and quality of life in spise of maximal tolerated therapy and are candidates for stem cell therapy
    Patienter med hjertesvigt der har nedsat hjertepumpefunktion, fysisk aktivitets kapacitet og livskvalitet på trods af maksimal tolererede behandling. Disse patienter er kandidater til stamcelleterapi.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To perform at clinical double-blind placebo-controlled CSCC_ASC multicentre study in heart failure patients to investigate the regenerative capacity of the CSCC_ASC treatment.
    At udføre et klinisk dobbelt-blindet placebo-kontrolleret CSCC_ASC multicenterstudie hos patienter med hjertesvigt for at undersøge den regenerative kapacitet af CSCC_ASC behandling.
    E.2.2Secondary objectives of the trial
    Improvement in cardiac function and clinical symptoms
    Forbedringer i hjertets pumpefunktion og kliniske symptomer
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. 30 to 80 years of age
    2. Signed informed consent
    3. Chronic stable ischemic heart disease
    4. Heart failure (NYHA II-III)
    5. LVEF ≤45%
    6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP > 422 pg/ml (> 450 pmol/L) in patients with atrial fibrillation
    7. Maximal tolerable heart failure medication
    8. Medication unchanged two months prior to inclusion
    9. No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
    10. Patients who have had PCI or CABG within six months of inclusion must have a new angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis
    11. Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device
    Inklusionskriterier:
    1. 30 til 80 år
    2. Underskrevet informeret samtykke
    3. Kronisk stabil iskæmisk hjertesygdom
    4. Hjerteinsufficiens (NYHA II-III)
    5. LVEF ≤ 45%
    6. Plasma NT-pro-BNP> 300 pg / ml (> 35 pmol / L) i sinusrytme og plasma NT-pro-BNP> 422 pg / ml (> 450 pmol / L) hos patienter med atrieflimren
    7. Maksimal tolereret hjertesvigtsmedicin
    8. Medicin uændret to måneder forud for inklusion
    9. Ingen mulighed for perkutan koronar intervention (PCI) eller koronar bypassoperation (CABG)
    10. Patienter, der har haft PCI eller CABG senest seks måneder efter optagelsen skal have en ny angiografi mindre end en måned før optagelse eller i mindst fire måneder efter interventionen for at udelukke tidlig restenose
    11. Patienter kan ikke deltage før tre måneder efter implantation af en hjerte re-synkroniserings terapi apparat
    E.4Principal exclusion criteria
    Exclusion criteria
    1. Heart Failure (NYHA I or IV)
    2. Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
    3. Other revascularisation treatment within four months of treatment
    4. If clinically indicated the patient should have a coronary angiography before inclusion
    5. Moderate to severe aortic stenosis (valve area < 1.3 mm2) or valvular disease with option for surgery.
    6. Diminished functional capacity for other reasons such as: obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity
    7. Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes >14 109/L) or thrombocytopenia (thrombocytes < 50 109/L)
    8. Anticoagulation treatment that cannot be paused during cell injections
    9. Patients with reduced immune response
    10. History with malignant disease within five years of inclusion or suspected malignity – except treated skin cancer other than melanoma
    11. Pregnant women
    12. Other experimental treatment within four weeks of baseline tests
    13. Participation in another intervention trial
    Eksklusionskriterier
    1. hjerteinsufficiens (NYHA I eller IV)
    2. Akut koronart syndrom med elevation af CKMB eller troponiner, slagtilfælde eller forbigående cerebral iskæmi senest seks uger før inklusion
    3. Andre revaskularisering behandling inden for fire måneders periode efter behandling
    4. Hvis det er klinisk indiceret, bør patienten have en koronarangiografi før inklusion
    5. Moderat til svær aortastenose (klapåbning <1,3 mm2) eller valvulær sygdom med mulighed for kirurgi.
    6. Formindsket funktionsevne af andre årsager, såsom: obstruktiv lungesygdom (KOL) med forceret ekspirations volumen (FEV) <1 L / min, moderat til svær bensmerter eller fedme
    7. Klinisk signifikant anæmi (hæmoglobin <6 mmol / L), leukopeni (leukocytter <2 109 / L), leukocytose (leukocytter> 14 109 /L) eller trombocytopeni (trombocytter <50 109 / L)
    8. antikoagulationsbehandling som ikke kan pause under celleinjektioner
    9. Patienter med nedsat immunforsvar
    10. Historie med ondartet sygdom inden for fem år før inklusion undtagen behandlet hudkræft bortset melanom
    11. Gravide kvinder
    12. Andre eksperimentelle behandlinger indenfor fire uger før baseline tests
    13. Deltagelse i et andet interventionsforsøg
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up between CSCC_ASC and placebo patients.
    Det primære endpoint er ændring i venstre ventrikel ende-systolisk volumen (LVESV) ved 6 måneders opfølgning mellem CSCC_ASC og placebo patienter.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after treatment
    6 måneder efter behandlingen
    E.5.2Secondary end point(s)
    The secondary endpoints are safety evaluated by development of allogeneic antibodies and laboratory safety measurements 1 and 6 months after treatment and changes in left ventricular ejection fraction (LVEF), end-diastolic volume and myocardial mass at 6 months follow-up. The changes in left ventricle function will be measured by echocardiography (ECHO) or computed tomography (CT). LVESV is a widely used measure of the functional status of the left ventricle and is superior to LVEF for prediction of survival in patients with LVEF below 50%. Other secondary endpoints are changes in NYHA, CCS, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6 min walking test and NT-pro-BNP. In addition, safety of allogeneic CSCC_ASCs with respect to incidence and severity of serious adverse events and suspected unrelated serious adverse events will be evaluated at 12 months follow-up.
    A combined endpoint of
    1. death, hospitalization for worsening heart failure including inserting of a bi-ventricular pacemaker, hospitalization because of ventricular tachycardia or fibrillation and increased heart failure medical treatment 1, 2 and 3 years after treatment
    2. death, hospitalization for any cardiovascular reason, hospitalization for worsening heart failure including inserting of a bi-ventricular pacemaker, hospitalization because of ventricular tachycardia or fibrillation and increased heart failure medical treatment 1, 2 and 3 years after treatment.
    De sekundære endpoints er sikkerhed evalueret ved udvikling af allogene antistoffer og laboratorium sikkerhedsmæssige målinger 1 og 6 måneder efter behandling og ændringer i venstre ventrikels uddrivningsfraktion (LVEF), slutdiastolisk volumen og myokardiemasse ved 6 måneders opfølgning. Ændringerne i venstre ventrikel funktion vil blive målt ved ekkokardiografi (ECHO) eller computertomografi (CT). LVESV er et almindeligt anvendt mål for den funktionelle status af den venstre ventrikel og er overlegen i forhold til LVEF til forudsigelse af overlevelse hos patienter med LVEF under 50%. Andre sekundære effektmål er ændringer i NYHA, CCS, Kansas City Kardiomyopati Spørgeskema (KCCQ), 6 min gangtest og NT-pro-BNP. Desuden vil sikkerheden for allogene CSCC_ASCs med hensyn til forekomsten og sværhedsgraden af alvorlige bivirkninger og formodede uafhængige alvorlige bivirkninger vurderes efter 12 måneders opfølgning.
    En kombineret endepunkt
    1. død, hospitalsindlæggelse for forværret hjertesvigt, herunder indsættelse af et bi-ventrikulær pacemaker, hospitalsindlæggelse på grund af ventrikulær takykardi eller hjerteflimmer og øget hjertesvigt medicinsk behandling 1, 2 og 3 år efter behandling
    2. dødsfald, hospitalsindlæggelse for enhver kardiovaskulær årsag, hospitalsindlæggelse for forværret hjertesvigt, herunder indsættelse af et bi-ventrikulær pacemaker, hospitalsindlæggelse på grund af ventrikulær takykardi eller hjerteflimmer og øget hjertesvigt medicinsk behandling 1, 2 og 3 år efter behandlingen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 6 months after treatment and 1, 2 and 3 years
    1 og 6 måneder efter behandlingen, samt 1, 2 og 3 år
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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
    The patients will have follow-up visit 1 year after treatment, then the safety of the study will be follow year 2 and 3 after the therapy in hospital registries
    Patienterne vil have klinisk follow-up 1 år efter behandlingen. Der vil herefter være opfølgning år 2 og 3 af sikkerhedsdata via hospitalsregistre
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 61
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-05-12. Yes
    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 state81
    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 Decision2015-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-01
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