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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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:2021-002246-32
    Sponsor's Protocol Code Number:DWN.0710.008.2020P
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-01-24
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-002246-32
    A.3Full title of the trial
    Evaluation of myocardial uptake of CardioCell in patients with non-ischaemic heart failure using the CIRCULATE catheter for transcoronary administration of pharmacologic and cell-based agents (CIRCULATE-PLUS)
    Ocena wychwytu sercowego CardioCell u pacjentów z nie-ischemiczną niewydolnością serca używając katetera CIRCULATE do przezwieńcowego dostarczania leków i substancji komórkowych (CIRCULATE-PLUS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of myocardial uptake of CardioCell in patients with non-ischaemic heart failure using the CIRCULATE catheter for transcoronary administration of pharmacologic and cell-based agents (CIRCULATE-PLUS)
    Ocena wychwytu sercowego CardioCell u pacjentów z nie-ischemiczną niewydolnością serca używając katetera CIRCULATE do przezwieńcowego dostarczania leków i substancji komórkowych (CIRCULATE-PLUS)
    A.3.2Name or abbreviated title of the trial where available
    CIRCULATE-PLUS
    A.4.1Sponsor's protocol code numberDWN.0710.008.2020P
    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 SponsorKrakowski Szpital Specjalistyczny im. Jana Pawla II
    B.1.3.4CountryPoland
    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 supportKrakowski Szpital Specjalistyczny im. Jana Pawla II
    B.4.2CountryPoland
    B.4.1Name of organisation providing supportBalton Sp. z o.o.
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKrakowski Szpital Specjalistyczny im. Jana Pawla II
    B.5.2Functional name of contact pointResearch Department
    B.5.3 Address:
    B.5.3.1Street AddressPradnicka 80
    B.5.3.2Town/ cityKrakow
    B.5.3.3Post code31-202
    B.5.3.4CountryPoland
    B.5.4Telephone number48126142582
    B.5.6E-mailbadaniakliniczne@szpitaljp2.krakow.pl
    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 nameCardioCell
    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 INNWharton's jelly-derived mesenchymal stem cells
    D.3.9.3Other descriptive nameAllogeneic Wharton's jelly-derived mesenchymal stem cells
    D.3.9.4EV Substance CodeSUB197611
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.4 to 1.6
    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 EMA/CAT/625295/2016
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Perlinganit
    D.2.1.1.2Name of the Marketing Authorisation holderMerus Labs Luxco II S.À R.L.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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.3.4Pharmaceutical form Solution for infusion
    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 INNGlyceryl trinitrate
    D.3.9.1CAS number 55-63-0
    D.3.9.3Other descriptive nameGLYCERYL TRINITRATE
    D.3.9.4EV Substance CodeSUB13997MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) No
    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 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
    Dilated cardiomyopathy
    Kardiomiopatia rozstrzeniowa
    E.1.1.1Medical condition in easily understood language
    Dilated cardiomyopathy
    Kardiomiopatia rozstrzeniowa
    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 10056419
    E.1.2Term Dilated cardiomyopathy
    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 objective of the study is evaluation of the myocardial uptake of Wharton’s Jelly mesenchymal stem cells (CardioCell) administered by perfusion method via CIRCULATE catheter in patients with dilated cardiomyopathy.
    Celem badania jest ocena wychwytu sercowego komórek macierzystych galarety Whartona (CardioCell) podanych metodą perfuzyjną przez cewnik CIRCULATE u pacjentów z kardiomiopatią rozstrzeniową.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 18-80 years
    - Diagnosis of dilated cardiomyopathy (DCM)
    - Left ventricular ejection fraction (LVEF) ≤ 45% by echocardiography
    - Clinically stable heart failure in NYHA class II or III, at least three months from the last exacerbation
    - Signed informed consent
    - Pacjenci w wieku 18-80 lat
    - Rozpoznanie kardiomiopatii rozstrzeniowej
    - Frakcja wyrzutowa lewej komory ≤45% w ocenie echokardiograficznej
    - Klinicznie stabilna niewydolność serca w klasie II-III NYHA, co najmniej trzy miesiące od ostatniego zaostrzenia
    - Podpisana świadoma dobrowolna zgoda na udział w badaniu
    E.4Principal exclusion criteria
    - Less than 3 months from any substantial cardiac therapeutic intervention (such as, e.g. CRT/ICD fitting)
    - Clinically unstable heart failure and/or clinical exacerbation within the last 3 months
    - Coronary Artery Disease/ Chronic coronary syndrome as a underline cause of heart failure
    - BMI lower than 18 or greater than 45 kg/m2
    - Severe valvular heart disease or other structural interventions
    - Present candidate for heart transplantation
    - Active or any history of malignancy or tumor
    - Moderate or severe immunodeficiency
    - Chronic immunosuppressive therapy
    - Acute or chronic infection
    - Coagulopathies
    - Known alcohol or drug dependence
    - Severe renal dysfunction (eGFR<20mL/min)
    - Soft tissue disease or local infection in a place of required artery puncture
    - Pregnancy or breastfeeding
    - Females of childbearing potential who do not use a highly effective method of contraception, and in absence of a negative highly sensitive urine or serum pregnancy test
    - Participation in any other clinical research study that has not reached its primary efficacy endpoint or otherwise would interfere with the patient’s participation in this project
    - Life expectancy <12 months
    - Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study
    - Any objective or subjective reason for inability to attend follow-up visits
    - Mniej niż 3 miesiące od jakiejkolwiek istotnej kardiologicznej interwencji terapeutycznej (takiej jak np. dopasowanie CRT/ICD)
    - Klinicznie niestabilna niewydolność serca i/lub zaostrzenie kliniczne w ciągu ostatnich 3 miesięcy
    - Choroba niedokrwienna serca/przewlekły zespół wieńcowy jako główna przyczyna niewydolności serca
    - BMI poniżej 18 lub powyżej 45 kg/m2
    - Istotna choroba zastawkowa serca lub inne wymagające interwencji strukturalnej
    - Aktualny kandydat do przeszczepu serca
    - Wywiad choroby nowotworowej lub obecna choroba nowotworowa
    - Umiarkowany lub ciężki niedobór odporności
    - Przewlekła terapia immunosupresyjna
    - Ostra lub przewlekła infekcja
    - Koagulopatie
    - Znane uzależnienie od alkoholu lub narkotyków
    - Ciężka dysfunkcja nerek (eGFR<20ml/min)
    - Choroby tkanek miękkich lub infekcja w okolicy dostępu naczyniowego
    - Ciąża lub karmienie piersią
    - Kobiety w wieku rozrodczym, które nie stosują wysoce skutecznej metody antykoncepcji oraz w przypadku braku ujemnego wysoce czułego testu ciążowego z moczu lub surowicy
    - Udział w innym badaniu klinicznym, które nie osiągnęło pierwotnego punktu końcowego lub mogłoby w inny sposób kolidować z udziałem pacjenta w obecnym badaniu
    - Oczekiwane przeżycie <12 miesięcy
    - Jakakolwiek współistniejąca choroba lub stan, który w opinii badacza uniemożliwiłby pacjentowi udział w badaniu
    - Wszelkie obiektywne lub subiektywne przyczyny niemożności uczestniczenia w wizytach kontrolnych
    E.5 End points
    E.5.1Primary end point(s)
    CardioCell delivery success, defined as the device introduction, administration of nitroglycerine and cell-based agent, device removal without complications, and myocardial uptake of labeled CardioCell.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On the day of procedure.
    E.5.2Secondary end point(s)
    1. Freedom from major adverse cardiovascular events during the index hospitalization.
    2. Freedom from major adverse cardiovascular events by 30 days after the discharge.
    3. Left ventricular ejection fraction ( by echocardiography) at 30 days after the discharge.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ad.1. During index hospitalization.
    ad.2. Within 30 days after discharge.
    ad.3. Within 30 days after discharge.
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 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
    LVLS
    Ostatnia wizyta ostatniego pacjenta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days28
    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: 2
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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.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)
    Expected normal treatment of the condition
    Zwyczajowe leczenie lub opieka nad pacjentami z kardiomiopatią rozstrzeniową.
    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 Decision2023-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-19
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