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    Summary
    EudraCT Number:2019-002511-26
    Sponsor's Protocol Code Number:08062019
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-11-06
    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 number2019-002511-26
    A.3Full title of the trial
    Repeated Injection Therapy of Allogeneic Stem Cells in Ischemic No-option Patients
    - A Multi-Centre Study (SCIENCE REPEAT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Allogeneic adipose derived stromal cell therapy in patients with ischemic heart failure
    A.3.2Name or abbreviated title of the trial where available
    SCIENCE REPEAT
    A.4.1Sponsor's protocol code number08062019
    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 supportRigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointAbbas Ali Qayyum
    B.5.3 Address:
    B.5.3.1Street AddressInge Lehmanns Vej 7
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535451076
    B.5.6E-mailabbas.ali.qayyum@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 nameCSCC_ASC
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracardiac use
    Intramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameALLOGENEIC ADIPOSE DERIVED STROMAL CELLS
    D.3.9.4EV Substance CodeSUB182663
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Ischemic heart failure
    E.1.1.1Medical condition in easily understood language
    Patients with heart failure due to chronic ischemic heart failure without any further options for treatment
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019285
    E.1.2Term Heart failure, unspecified
    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
    The aim of this trial is to investigate the treatment effect of repeat intra-myocardial injections of 100 million allogeneic CSCC_ASCs 6 months apart in patients with severe ischemic heart failure (≤40%), in a randomized controlled study.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. 30 to 85 years of age
    2. Written informed consent
    3. Chronic stable ischemic heart disease
    4. Symptomatic heart failure (NYHA II-III)
    5. LVEF ≤40 % documented by echocardiography, CT or MRI obtained after up-titration of heart failure medication (if previously treated with cardiac resynchronisation at least 3 months after implantation)
    6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP > 422 pg/ml (> 49 pmol/L) in those patients with atrial fibrillation
    7. Maximal tolerable heart failure medication
    8. Heart failure medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics are acceptable
    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 and at least four months after the intervention to rule out early restenosis
    E.4Principal exclusion criteria
    Exclusion criteria
    1. NYHA I or IV heart failure
    2. Implantation of a cardiac resynchronisation therapy device (CRT) within 3 months or Implantable Cardioverter Defibrillator (ICD) 1 month
    3. Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
    4. Other revascularisation treatment within four months of treatment
    5. Moderate to severe aortic stenosis (valve area < 1.3 cm2) 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, severe arthrosis or severe pain from the musculoskeletal system, or morbid obesity
    7. Clinically 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
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is change in left ventricle end-systolic volume (LVESV) at 12 months follow-up after first treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after (first) treatment
    E.5.2Secondary end point(s)
    The secondary endpoints are changes in left ventricular ejection fraction (LVEF), end-systolic volume, end-diastolic volume and myocardial mass at 6 and 12 months follow-up. Other secondary endpoints are changes in NYHA, CCS, Kansas City Cardiomyopathy Questionnaire (KCCQ), Seattle Angina Questionnaire and EQ5D3L Questionnaire, 6 min walking test, additional echocardiographic measures and NT-pro-BNP.
    Moreover, secondary safety endpoint is evaluating development of allogeneic antibodies and laboratory safety measurements 3, 6 and 12 months after treatment.
    In addition, safety of allogeneic CSCC_ASCs with respect to incidence and severity of SAEs 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 12, 24, 36 months after (first) 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 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 Yes
    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 No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Standard care
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 Yes
    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 is expected to be in 2022
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2019-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-09-25
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