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    Summary
    EudraCT Number:2011-001117-13
    Sponsor's Protocol Code Number:C3BS-C-11-01
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-21
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2011-001117-13
    A.3Full title of the trial
    Efficacy and Safety of Bone Marrow-Derived Mesenchymal Cardiopoietic Cells (C3BS-CQR-1) for the Treatment of Chronic Advanced Ischemic Heart Failure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study aiming at investigating the potential effectiveness and safety of a treatment for chronic advanced heart failure of ischemic origin. The treatment is based on patient own stem cells that will be collected and guided to the cardiac cells lineage before being injected into the heart muscle.
    A.3.2Name or abbreviated title of the trial where available
    Congestive Heart failure cArdiopoietic Regenerative Therapy-1 (CHART-1) trial
    A.4.1Sponsor's protocol code numberC3BS-C-11-01
    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 SponsorCardio3 BioSciences SA
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCardio3 BioSciences SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardio3 BioSciences SA
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressRue Edouard Belin 12
    B.5.3.2Town/ cityMont-Saint-Guibert
    B.5.3.3Post code1435
    B.5.3.4CountryBelgium
    B.5.4Telephone number3210394100
    B.5.5Fax number3210394141
    B.5.6E-mailregulatory@c3bs.com
    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 nameC3BS-CQR-1
    D.3.2Product code C3BS-CQR-1
    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 INNAutologous bone marrow-derived cardiopoietic stem cells
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeC3BS-CQR-1
    D.3.9.3Other descriptive nameAutologous bone marrow-derived cardiopoietic stem cells
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6billions cells
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberTissue engineered product - Ref. EMA/665587/2011
    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
    Chronic advanced symptomatic heart failure secondary to ischemic cardiomyopathy
    E.1.1.1Medical condition in easily understood language
    Advanced heart failure of ischemic origin
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10010684
    E.1.2Term Congestive 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
    The primary objective is to evaluate the efficacy of C3BS-CQR-1 by comparing the overall response to C3BS-CQR-1 relative to standard of care undergoing a sham procedure using a composite outcome of morbidity and mortality, changes in quality of life , six-minute walk distance, and left ventricular structure and function at 39 weeks (9 months) post-procedure.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety of C3BS-CQR-1 by comparing the incidence of serious adverse events between study groups at 52 weeks (12 months) post-procedure and all cause mortality at 104 weeks (24 months) post-procedure.
    Additionally data will be collected to evaluate the safety and performance of the endoventricular injection catheter C-Cath® as a system for delivery of C3BS-CQR-1 into the left ventricular myocardium.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible patients must meet all of the following inclusion criteria:
    1. Age ≥ 18 and < 80 years.
    2. Systolic dysfunction with LVEF ≤ 35% as assessed by echocardiography.
    3. Ischemic heart failure without known need for revascularization.
    4. Total MLHFQ score > 30.
    5. Ability to perform a Six-Minute Walk Test > 100 m and ≤ 400 m.
    6. History of hospitalization for HF within 12 months prior to screening or treatment in an out-patient clinic with intravenous vasoactive therapy (including vasodilators, positive inotropic agents and vasopressors) or diuretics for worsening HF within 12 months prior to screening.
    7. Be or must have been within the previous 12 months in NYHA class III or IV or INTERMACS class 4, 5, 6 or 7, and at the time of inclusion, must be at least in NYHA class II or greater.
    8. Use of ACE inhibitor and/or ARB; and beta blocker, for at least 3 months prior to screening visit, unless intolerant or contraindicated.
    9. Stable dosing of ACE inhibitor, ARB, beta blocker, aldosterone blocker, and diuretics for at least one month prior to screening visit, defined as ≤50% change in total dose of each agent.
    10. Willing and able to give written informed consent.

    E.4Principal exclusion criteria
    Eligible patients must meet none of the following exclusion criteria:
    1. Women who are pregnant, confirmed by a positive urine or serum hCG laboratory test at screening.
    2. Women of child-bearing potential without a negative serum or urine pregnancy test at screening or who are not practicing a reliable form of birth control. Women who are postmenopausal (12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH level > 40 IU/m or 6 weeks post surgical bilateral oophorectomy) or surgically sterile are not considered to be of child-bearing potential. Reliable contraception includes surgical sterilization, hormonal contraception, or double-barrier methods.
    3. Men refusing to exercise a reliable form of contraception.
    4. Myocardial infarction, unstable angina or percutaneous coronary intervention (PCI) within 90 days prior to screening, or CABG surgery within 180 days prior to screening.
    5. Patient on a cardiac transplant list or previously received any solid organ transplant.
    6. Previously underwent cardiac surgery with remodeling procedure, left ventricular assist device placement or cardiomyoplasty. This exclusion does not apply to patients who underwent ventricularplasty without placements device >1 year ago.
    7. Patient has undergone cardiac resynchronization therapy (CRT) within 6 months (180 days) prior to screening.
    8. Severe uncontrolled HF requiring need for intensive intravenous diuretics or inotropic support within 1 month prior to screening.
    9. Inability to perform a Six-Minute Walk Test due to physical limitations other than HF including:
    a. Severe peripheral vascular disease
    b. Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) limiting exercise
    c. Orthopedic limitations, severe muscular diseases, any other joint or muscular disease or neurological disorder (such as an old stroke or neuropathy) limiting the ability to walk for 6 minutes.
    10. Dependence on chronic oral steroid therapy.
    11. Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to screening.
    12. Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenital cardiomyopathy.
    13. BMI < 19 or > 45.
    14. Left ventricular thrombus.
    15. Left ventricular wall thickness < 8mm visualized in more than 50% of LV, and defined as a “LV no-go zone
    16. LV aneurysm or candidate for surgical aneurysmectomy.
    17. Sustained VT or VF which led to AICD therapy (shock) within 3 months prior to screening.
    18. Primary significant organic valvular heart disease.
    19. Moderate to severe aortic valve disease precluding catheter entry into the LV.
    20. Mechanical prosthetic valve in aortic or mitral position.
    21. Chronic infection or active malignancy.
    22. Patient has compromised renal function as reflected by a serum creatinine level >3.0 mg/dL (>0.265 mmol/l) or is currently on dialysis.
    23. Hematocrit < 28%.
    24. Atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degree that could impede or preclude the safe retrograde passage of the delivery catheter.
    25. Chronic immunosuppressive therapy due to inflammatory or systemic disease.
    26. Patient tested positive for HIV 1 or 2, Hepatitis B or C, HTLV 1 or 2 (if requested by regulations) or syphilis.
    27. Exposure to any previous experimental cell or angiogenic therapy and/or myocardial laser therapy and/or therapy with another investigational drug within 60 days prior to screening or enrollment in any concurrent study that may confound the results of this study.
    28. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate.
    29. Any illness other than CHF which might reduce life expectancy to less than 2 years from screening.
    30. Known and relevant allergies and/or hyper-sensitivities to Dextran or other plasma volume expanders to include Gentran, Hyskon and Macrodex.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will measure the efficacy of C3BS-CQR-1 injection at 39 weeks (9 months) based on a hierarchical composite of:
    1. All-cause mortality.
    2. Worsening of heart failure events defined as requiring unscheduled treatment for signs and symptoms of heart failure in an urgent outpatient setting or requiring hospital admission, as adjudicated by a Clinical Events Committee.
    3. Change in MLHFQ total score.
    4. Change in Six-Minute Walk Test (6MWT)
    5. Change in LVESV as assessed by echocardiography
    6. Change in LVEF as assessed by echocardiography.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 39 weeks (9 months) post index procedure.
    E.5.2Secondary end point(s)
    Safety endpoints will include the following:
    1. The occurrence of the following clinical events: death and cause of death, re-admissions and cause of re-admission, cardiac transplantation, myocardial infarction, stroke.
    2. Incidence of serious adverse events.
    3. Incidence of non-serious adverse events.

    Secondary efficacy endpoints will include the effect of C3BS-CQR-1 injection at 52 weeks (12 months) on:
    1. Time to all cause mortality.
    2. Worsening of heart failure events defined as requiring unscheduled treatment for signs and symptoms of heart failure in an urgent outpatient setting or requiring hospital admission, as adjudicated by a Clinical Events Committee.
    3. Aborted sudden death events, defined as resuscitated sudden death or appropriate Automatic Implantable Cardioverter Defibrillator (AICD) therapy for severe ventricular tachyarrhythmias.

    Tertiary (explorative) efficacy endpoints will include the effect of C3BS-CQR-1 injection on each of the components of the composite endpoint at 39, and 52 weeks (9 and 12 months) unless otherwise specified:
    1. Time to all cause mortality.
    2. Time to cardiovascular (CV) mortality.
    3. Worsening of heart failure events defined as requiring unscheduled treatment for signs and symptoms of heart failure in an urgent outpatient setting or requiring hospital admission, as adjudicated by a Clinical Events Committee.
    4. Aborted sudden death events, defined as resuscitated sudden death or appropriate AICD therapy for severe ventricular tachyarrhythmias.
    5. Re-admissions for heart failure.
    6. Total days alive out of hospital.
    7. Change in Six-Minute Walk Test from pre-procedure.
    8. Change in MLWHF Questionnaire from pre-procedure.
    9. Change in LVESV, LVEDV, LVEF and Left Ventricular Mass Index assessed by echocardiography from pre-procedure to 6, 9 and 12 months.
    10. Change in NT-pro-BNP level from pre-procedure to 9 months.
    11. Changes in INTERMACS class from pre-procedure and proportion of patients with improved INTERMACS classification.
    12. Changes in NYHA class from pre-procedure and proportion of patients with improved NYHA classification.
    13. Change in blood cell counts, CRP, and renal function (Creatinine).
    14. Total cost and healthcare utilization.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety endpoints (clinical events as defined in E.5.2 and serious adverse events): through 52 and 104 weeks (12 and 24 months) post index procedure.
    Safety endpoints (Non-serious adverse events): through 52 weeks (12 months) post index procedure.
    Secondary Efficacy endpoints: at 52 weeks (12 months) post index procedure.
    Tertiary efficacy endpoints: at 39 and 52 weeks (9 and 12 months) post index procedure.
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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
    Sham-controlled trial
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bosnia and Herzegovina
    Bulgaria
    Croatia
    Estonia
    France
    Hungary
    Ireland
    Israel
    Italy
    Latvia
    Lithuania
    Poland
    Romania
    Serbia
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 240
    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)
    Standard of care
    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 Decision2015-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-10
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