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    Summary
    EudraCT Number:2017-000516-42
    Sponsor's Protocol Code Number:CLX003-IMP-2-170121
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-07-03
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-000516-42
    A.3Full title of the trial
    A Phase IIB, Randomised, Double-Blinded, Placebo-Controlled Study of the Efficacy and Safety of Intramyocardial Injection of Allogeneic Human Immunomodulatory Progenitor (iMP) cells in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIB Study of the Efficacy and Safety of Intramyocardial Injection of Allogeneic Human Immunomodulatory Progenitor (iMP) cells in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery.
    A.4.1Sponsor's protocol code numberCLX003-IMP-2-170121
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03515291
    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 SponsorCell Therapy Ltd (trading as Celixir)
    B.1.3.4CountryUnited Kingdom
    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 supportCell Therapy Ltd (trading as Celixir)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCell Therapy Ltd (trading as Celixir)
    B.5.2Functional name of contact pointNigel Scott
    B.5.3 Address:
    B.5.3.1Street AddressCelixir House, Innovation Way,Stratford Business & Technology Park,Banbury Road,
    B.5.3.2Town/ cityStratford-upon-Avon
    B.5.3.3Post codeCV37 7GZ
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailnigel.scott@celixir.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 nameAllogeneic Human Immunomodulatory Progenitor (iMP) cells (Heartcel)
    D.3.4Pharmaceutical form 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 INNHeartcel
    D.3.9.3Other descriptive nameImmunomodulatory progenitor (iMP) cells for intramyocardial injection
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4000000 to 4000000
    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 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 numberEMA/CAT/18436/2016: considers that the Product falls within the definition of a tissue engineered product
    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 placeboInjection
    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
    Ischaemic heart disease post MI
    E.1.1.1Medical condition in easily understood language
    Treatment of ischaemic heart disease post heart attack
    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 PT
    E.1.2Classification code 10048858
    E.1.2Term Ischaemic cardiomyopathy
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023024
    E.1.2Term Ischaemic heart disease
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of iMP cells administered by intramyocardial (IM) injection in individuals undergoing CABG surgery.
    E.2.2Secondary objectives of the trial
    To assess the safety of iMP cells administered by IM injection in individuals undergoing CABG Surgery.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • >= 15% left ventricular (LV) scar volume measured by Late Gadolinium Enhancement (LGE) Cardiovascular Magnetic Resonance (CMR).
    • LV Ejection fraction <= 50%. • Ischaemic heart disease in which CABG is the recommended revascularisation strategy.
    • Age range: 18 years of age and over with no history of congenital cardiac anomalies (men and women).
    • Able to provide written informed consent (including willingness to have two CMRs).
    • New York Heart Association (NYHA) class >=2 and/or Canadian Cardiovascular Society (CCS) class angina >=2.
    • For women of child bearing potential (WOCBP): Negative (non-pregnant) beta-human chorionic gonadotropin (beta-hCG) blood test.
    E.4Principal exclusion criteria
    Exclusion Criteria
    • Previous cardiac surgery.
    • Requirement for additional cardiac surgery (e.g. concomitant valve replacement).
    • Estimated Glomerular Filtration Rate (GFR) of <30mL/min.
    • Contraindication to LGE-CMR.
    • Clinical history of malignancy within the last 5 years.
    • Comorbidities likely to influence the safety of performing the protocol.
    • Liver disease including Alanine Transaminase (ALT) 3 times or more the upper limit of normal.
    • Low platelet count (<100,000) platelets per microliter of blood.
    • Evidence of coagulopathy – International Normalised Ratio (INR) >2. Note: Elevated INR due solely to warfarin (or similar medication) is NOT an exclusion criterion. • Increased mortality risk over a 12-month period due to comorbidity.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change in LV scar volume (as assessed by LGE-CMR) from baseline to 15 weeks ± 2 weeks post-operatively.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    1. Change in CMR assessment of LVEF, LVEDVi, LVESVi, pattern of LV LGE, myocardial perfusion and myocardial strain from baseline to 15 weeks ± 2 weeks post-operatively. 2. MACE recorded at 30-days and 15 weeks ± 2 weeks post-surgery. MACE will be a composite of: 1. Cardiovascular death 2. Non-fatal MI 3. Non-fatal stroke 4. Unplanned cardiovascular hospitalisation 3. Major arrhythmic event at 30-days and 15 weeks ± 2 weeks post-surgery. 4. All-cause mortality at 30-days and 15 weeks ± 2 weeks post-surgery. 5. Change in Functional and Quality of Life (QoL) Assessments from baseline to 15 weeks ± 2 weeks post-operatively (4 QoL questionnaires): 1. NYHA classification 2. Kansas City Cardiomyopathy Questionnaire (KCCQ) 3. Minnesota Living with Heart Failure (MLHF) Score 4. EQ5D questionnaire 5. Length of hospital, intensive care unit, and high dependency unit admission 6. Change in blood biomarkers: Biomarkers to be measured before surgery, for 72 hours (12h, 24h, 48h, 72h) post-surgery, at 7 days, at 30 days and 15 weeks ± 2 weeks post-surgery. A. Standard Markers 1. Urea and Electrolytes 2. Liver function tests (LFTs) 3. Full blood count (FBC) B. Exploratory Markers 4. Uric acid 5. Lipid profile 6. High sensitivity (Hs)-C-reactive protein (CRP) 7. Hs-Troponin 8. N terminal (NT) pro brain natriuretic peptide (NT-proBNP) 9. Fibrotic and inflammatory pathways 10. Metabolomic and proteomic networks
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study Follow-Up: 15 weeks ± 2 weeks post-CABG surgery for efficacy and safety endpoints with up to 12 months post-surgery open label monitoring.
    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 Yes
    E.6.13.1Other scope of the trial description
    The study is a phase IIB, randomised, double-blinded, placebo-controlled, single trial centre. It is designed to assess the safety and efficacy of intramyocardial injections of allogeneic immunomodulatory progenitor (iMP) cells in individuals with ischaemic cardiomyopathy undergoing CABG. The sample size is 50 participants for this trial.
    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 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 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
    The end of the trial will be defined as the "last patient last visit" .
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state50
    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)
    15 weeks ± 2 weeks post-CABG surgery for efficacy and safety endpoints with up to 12 months post-surgery open label monitoring.
    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 Decision2017-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-10-05
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