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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2013-001358-81
    Sponsor's Protocol Code Number:CTPX01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-18
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-001358-81
    A.3Full title of the trial
    "First-in-human clinical trial, double blind, randomized with placebo, open for the six first patients (dose ranging), to evaluate the safety and efficacy of intracoronary infusion of allogeneic human cardiac stem cells (CSCs) in patients with Acute Myocardial Infarction and Left Ventricular Dysfunction." - CAREMI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First-in-human clinical trial using human cardiac stem cells obtained from a donor for Acute Myocardial Infarction treatment. Patients will receive either cells or placebo by intracoronary infusion to evaluate the safety and efficacy of this treatment.
    A.3.2Name or abbreviated title of the trial where available
    CAREMI
    A.4.1Sponsor's protocol code numberCTPX01
    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 SponsorCoretherapix S.L.U.
    B.1.3.4CountrySpain
    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 supportCoretherapix S.L.U.
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportEuropean Commision - Seventh Framework Programme (FP7)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCoretherapix
    B.5.2Functional name of contact pointOperaciones Clinicas
    B.5.3 Address:
    B.5.3.1Street AddressCalle Marconi, 1 Parque Tecnológico de Madrid
    B.5.3.2Town/ cityTres Cantos
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number34918049264
    B.5.5Fax number34918049263
    B.5.6E-mailmariepaule.richard@tigenix.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.3.2Product code AlloCSC-01
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCardioblastos troncales adultos alogénicos cardíacos expandidos
    D.3.9.3Other descriptive nameHuman allogeneic adult stem cells extracted from heart tissue an "in vitro" expanded
    D.3.9.4EV Substance CodeSUB126475
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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 infusion
    D.8.4Route of administration of the placeboIntracoronary use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Myocardial Infarction (AMI):
    "First STEMI submitted to elective primary PCI with successful revascularization by PCI (TIMI = 3), but intermediate-high risk of HF development (infarct size by MRI>25%)"
    E.1.1.1Medical condition in easily understood language
    Heart Attack
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    The primary objective consists in the evaluation of the safety of the treatment:
    - In the dose escalation phase the principal objective is to evaluate the safety and feasibility of the procedure (MRI and administration method) that is not part of the routine care of a heart attack, and confirm that the target dose can be administered intracoronary in a safe way.
    The following will be assessed:
    o Deaths from any cause within 30 days
    o Adverse Events (AEs) of any nature observed from magnetic resonance imaging (MRI) of patient inclusion to up to 7 days after treatment administration.

    - In the randomization phase, the Major Adverse Cardiac Events (MACE) will be assessed for the first 30 days of treatment administration, defined as death from any cause, new myocardial infarction, hospitalization for failure heart, ventricular tachycardia (VT), ventricular fibrillation (VF) and stroke.
    E.2.2Secondary objectives of the trial
    FOLLOW-UP SAFETY:
    MACE in the first 6 months and at 12 months. Death from any cause. Death from cardiovascular cause. General monitoring of all serious adverse events from any cause.
    EFFICACY:
    Evolution of infarct (morphology): % change in MRI at 6 and 12 months after treatment administration vs. screening MRI and 1 month MRI. Compare CSC versus placebo. Evolution of edema: % change in MRI at 1 month after treatment administration vs screening MRI. Evolution of the biomechanical parameters by MRI: % changes of MRI at 6 and 12 months of administration of the treatment vs screening MRI and 1 month MRI. Compare CSC vs placebo.
    CLINICAL PARAMETERS OF ANALYSIS: ProBNP curve (one day prior to 2nd hemodynamic assessment, 6 months, 12 months). CRP (one day prior to 2nd hemodynamic assessment, at discharge, 1 month). 6 minute walking test at discharge, 6 and 12 months. NYHA at discharge, 6 and 12 months. MLHFQ at discharge, 6 and 12 months. Hospital admission for HF. CCV mortality.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Initial clinical pre-screening:
    1. Males and females > or =18 years and < or = 80 years
    2. Patients who present a STEMI according to the universally accepted definition found in the STEMI management guide of the European Society of Cardiology
    3. Killip < or = 2 on admission
    4. Successful revascularization by PCI (TIMI = 3) within 12 hours after the onset of symptoms.
    5. Ejection Fraction (EF) ≤50% by echocardiography performed more than 48 hours after hospital admission and before the screening MRI done between day 3 and day 5 after infarction.
    6. Bare-metal or drug-eluting stents of second generation (including new second generation stents, e.g. biolimus, novolimus, and bioreabsorbable stents) at coronary revascularization by PCI.
    MRI analysis:
    7. EF < or =45% (day 3 to 5 after STEMI)
    8. Infarct size in LV analyzed by MRI > or = 25% of LV mass
    Patients with infarct size ≥ 25% of LV and EF slightly bigger than 45% could be included after evaluation and approval by the Study Coordinators and the Sponsor.
    The presence of microvascular obstruction at MRI is permitted (needs to be indicated). Additional percutaneous interventions for additional coronary arteries revascularization are allowed if done 24h before the inclusion-MRI.
    New catheterization for the administration of cells:
    9. The infarct culprit coronary artery is adequate for treatment administration and the procedure is technically feasible.
    10. The patient is stable and in adequate clinical condition to undergo the procedure.
    E.4Principal exclusion criteria
    1. Participation in another clinical trial in the last 30 days
    2. Previous allogeneic transplant (blood transfusion are allowed) or treated with cell or gene therapy
    3. Previous Q-wave infarction
    4. Significant valve disease, relapsing pericarditis, history of cardiac tamponade, cardiomyopathies
    5. Severe stenotic lesions (>90%) in a coronary vessel with size >2.75 mm not treated by PCI at least 24 hours before the baseline MRI study
    6. Previous EF = or < 45%, NYHA > 2 or hospital admission for heart failure before STEMI
    7. Sustained VT that does not revert with treatment or requires >6 hours to be controlled in the 48 hours prior to the product administration procedure
    8. Complete atrioventricular blockade, or acute left bundle branch block in the 48 hours prior to the product administration procedure
    9. History of cardioembolic disease
    10. Platelets <100,000 and/or Hb<8.5g/dL
    11. Acute or chronic renal failure with creatinine ≥2.5 mg/dl or creatinine clearance ≤30 mL/min
    12. Infection with systemic involvement
    13. Cancer disease, except that eradicated at least 5 years before inclusion, and without receiving radiotherapy on chest. It is permitted coetaneous non-melanoma neoplasms completely eliminated (at any time) and that do not require subsequent chemotherapy or radiotherapy on chest.
    14. Child-Pugh's C stage chronic liver disease
    15. Baseline respiratory failure requiring oxygen at home
    16. Uncontrolled hypertension at screening despite treatment (systolic blood pressure [BP] ≥ 180 and/or diastolic BP ≥ 110)
    17. Very poorly controlled diabetes (Hb1Ac ≥8.5 g/dL) or with serious target organ lesion (peripheral vascular disease requiring revascularization or non revascularizable)
    18. History of autoimmune disease
    19. Primary or acquired immune deficiency or immunosuppressant treatment (including treatments with immunosuppressants in the previous three months or foreseeable need for those treatments during the course of the study).
    20. Women who are pregnant or breastfeeding or women of childbearing potential who do not agree to use contraceptives during the study period
    21. Life expectancy of less than 2 years for any reason.
    22. Allergy to amynoglicoside antibiotics or HSA hypersensitivity
    23. Contraindications preventing the use of Magnetic Resonance Imaging: Pacemaker, Implantable cardioverter-defibrillator (ICD), known reaction to gadolinium, claustrophobia, cochlear implants
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints: Safety variables
    - Any AE
    - MACE
    - Global mortality
    - Cardiovascular mortality
    Daily assessment of safety will be performed during the hospitalization phase; monthly evaluations will be performed during the first 6-months of follow-up and then quarterly assessments thereafter until the 12 months of the clinical trial.
    Dose-escalation phase: For the first 6 patients who comprise the dose-escalation phase of this protocol, the primary evaluation will be safety from the screening MRI performed and during the first week after administration of the therapy (AE and global mortality from any cause). Secondary evaluations will be identical to those at the randomized phase.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily assessment of safety will be performed during the hospitalization phase; monthly evaluations will be performed during the first 6-months of follow-up and then quarterly assessments thereafter until the 12 months of the clinical trial.
    E.5.2Secondary end point(s)
    Efficacy Variables:
    1. Evolution of infarct size comparing the percentage of change with respect to the LV. The analysis will be performed by MRI at 6 and 12 months after treatment administration versus screening MRI and 1 month MRI.
    2. Evolution of edema: comparing the percentage of change at 1 month after treatment administration versus edema at the moment of the screening. The analysis will be by MRI.
    3. Evolution of the biomechanical parameters comparing the percentage of changes at 6 and 12 months after administration of the treatment versus the ones at the moment of the screening or at month 1 after the administration. The analysis will be by MRI.
    All analysis will be performed by comparing the population treated with CSCs versus the one treated with placebo.

    Clinical Parameters:
    1. Nt-proBNP or BNP curve (according to the usual practice in each hospital). Comparing the Nt-proBNP or BNP levels just before treatment administration and at 6 and 12 months after treatment.
    2. CRP: comparing the CRP levels just before treatment administration, at hospital discharge, 7 days after treatment and 1 month after product administration.
    3. 6 minute walking test at hospital discharge and 6 and 12 months after treatment
    4. NYHA classification at hospital discharge and 3, 6 and 12 months after treatment
    5. MLHFQ at hospital discharge and 6 and 12 months after treatment
    6. Hospital admission for HF during the 12 months of the clinical trial will be registered.
    7. Follow-up of all the cases of cardiovascular mortality during the whole clinical trial.
    All analysis will be performed by comparing the population treated with CSCs versus the one treated with placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    First month and 6 and 12 months.
    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) Yes
    E.7.1.1First administration to humans Yes
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 (Last Visit of the Last Subject)
    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
    E.8.9.2In all countries concerned by the trial years2
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 55
    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 Decision2014-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
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