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    Summary
    EudraCT Number:2014-003457-34
    Sponsor's Protocol Code Number:CardAP-Zellen
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-07-27
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-003457-34
    A.3Full title of the trial
    Safety of autologous CardAP-cells in patients with dilatative cardiomyopathy: an open, monocentric, double-arm, 3+3 dose escalation, phase I/II study
    Sicherheit autologer CardAP-Zellen in Patienten mit dilatativer Kardiomyopathie: Eine offene, monozentrische, doppelarmige, 3+3-Dosiseskalations-, Phase I/II-Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of CardAP cells derived from patients own cardiac tissue for dilatative cardiomyopathy therapy
    Sicherheit von CardAP-Zellen hergestellt aus patienteneigenen Herzgewebe zur Therapie dilatativer Kardiomyopathie
    A.3.2Name or abbreviated title of the trial where available
    autoCard-Studie
    autoCard-Studie
    A.4.1Sponsor's protocol code numberCardAP-Zellen
    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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportCharité Universitätsmedizin Berlin
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBerlin-Brandenburger Zentrum für Regenerative Therapien (BCRT)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBundesministerium für Bildung und Forschung (BMBF)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointDr. Marion Haag
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number004930450539 437
    B.5.5Fax number004930450553937
    B.5.6E-mailmarion-renate.haag@charite.de
    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 nameCardAPcells
    D.3.2Product code CardAP-Zellen
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrapericardial use
    Intravenous use
    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) Yes
    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 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
    Patients with stable compensated dilatative cardiomyopathy, with maximum medical management and no further treatment option.
    Patienten mit stabiler kompensierter dilatativer Kardiomyopathie, mit maximaler Medikation und keiner weiteren Behandlungsoption.
    E.1.1.1Medical condition in easily understood language
    Patients with stable compensated dilatative cardiomyopathy, with maximum medical management and no further treatment option.
    Patienten mit stabiler ausgeglichener dilatativer Kardiomyopathie, mit maximaler Medikation und keiner weiteren Behandlungsoption.
    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 main study objective is to investigate the safety of CardAPcells in patients suffering from dilated cardiomyopathy. Moreover, secondary parameters of the study serve to demonstrate efficacy. The evaluation of efficcy is facilitated by measures of LV-function, coinciding with an improvement of life quality, examined by specialised questionnaires and standardised clinical examination methods.
    Das Hauptziel der Studie ist es, die Sicherheit und Verträglichkeit der Anwendung der CardAPcells in Patienten mit dilatativer Kardiomyopathie nachzuweisen. Zudem dienen die sekundären Parameter der Studie einer ersten Untersuchung der Wirksamkeit, welche durch eine Verbesserung der LV-Pumpleistung einhergehend mit einer Verbesserung der Lebensqualität, bewertet durch Fragebögen und entsprechende Standardtests üblich für die klinische Untersuchung solcher Patienten, untersucht werden kann.
    E.2.2Secondary objectives of the trial
    Not applicable
    Nicht zutreffend
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient information procedure and signed informed consent form
    2. Male and female participants at the age of 18-75 years
    3. Patients with chronic (> 3 months) dilated cardiomyopathy
    4. Ejection fraction (EF) ≤ 40 %
    5. NYHA II and III
    6. Medication stable at least 3 months prior study enrolment
    7. Heart rhythm stable at least 3 months prior to study enrolment
    8. Body weight between 60-100 kg at study enrolment
    9. Negative pregnancy test
    10. Highly effective contraception in women (defined as pearl index < 1 %)
    11. Not participating in any other study according to AMG (3 months prior and during participation)
    1. Durchgeführte Patientenaufklärung und schriftliche Einwilligung* (laut AMG §40 (1) 3b)
    2. Männlich oder weiblich im Alter zwischen 18 und 75 Jahren
    3. Patienten mit chronischer (> 6 Monate) dilatativer Kardiomyopathie (DCM)
    4. Ejektionsfraktion (EF) ≤ 40 %
    5. NYHA II und III
    6. Medikamentöse Einstellung über mind. 3 Monate vor Studieneinschluss stabil
    7. Herzrhythmus über mind. 3 Monate vor Studieneinschluss stabil
    8. Körpergewicht zwischen 60 und 100 kg zum Zeitpunkt des Studieneinschlusses
    9. Negativer Schwangerschaftstest
    10. Hocheffektive Kontrazeption bei Frauen (definiert als Pearl Index < 1 %)
    11. Keine Teilnahme an einer anderen Studie nach dem AMG (3 Monate vor und während der Teilnahme).

    *Für Studienteilnehmer, die nicht in der Lage sind, selbst zu lesen oder zu schreiben, geben eine mündliche Zustimmung, welche durch einen unvoreingenommenen Zeugen bestätigt wird. Dies ist nur dann akzeptabel, wenn der Studienteilnehmer die mündliche Erklärung durch den Prüfer vollständig verstanden hat. Der Zeuge sollte die Einverständniserklärung in Vertretung des Studienteilnehmers unterschreiben.
    E.4Principal exclusion criteria
    1. Atrial fibrillation
    2. Severe valve defect
    3. HIV 1 /2 positive
    4. Lues positive
    5. Active hepatitis B/C
    6. Previous myocardial infarction
    7. Ventricular wall thickness ≤ 5 mm
    8. Ventricular thrombus
    9. NT pro BNP ≤ 350 pg/ml
    10. Pregnancy and breast feeding
    11. Female patients of child-bearing potential*, unless patient is willing to use highly effective contraception** during study participation
    *Female patients of child-bearing potential are women who have passed menarche and are pre-menopausal or not permanantly sterilised (e.g. hysterectomy, bilateral salpingo-oophorectomy)
    **Highly effective contraception are methods that have a failure rate < 1 % per year, when applied correctly and regularly, defined as pearl index < 1 (e.g. hormonal contraception)

    12. Drug interaction with investigational medicinal product
    13. Known allergies/hypersensitivity towards IMP or excipients of pharmaceutical form
    14. Previous bone marrow transplantation
    15. Alcohol or drug abuse within the last 6 months prior study participation
    16. Positive test for active myocarditis
    17. malignant tumour detected at present or past time (excluding successfully treated non-metastatic squamous cell carcinomas of the skin)
    18. significant viral persistence of coxsackievirus or echovirus, adenoviruses, human cytomegaloviruses, Epstein-Barr virus, human herpesvirus 6, Borrelia Burgdorferi and parvovirus B19 (number of copies >800)
    19. major surgical procedure or major injury in the last 14 days
    20. body weight > 100 kg
    21. BMI ≥ 40 (morbid obesity)
    22. known autoimmune diseases (e.g. lupus, multiple sclerosis)
    23. diabetes type I and II (if HbA1c >7.5%)
    24. hypersensitivity reactions to penicillin and aminoglycoside antibiotics (streptomycin)
    25. hypersensitivity reactions to contrast media (Sonovue)
    26. hypersensitivity to clemastine, other antihistamines with similar chemical structure or any of the other ingredients (water for injection; propylene glycol; ethanol; sorbitol; sodium citrate).
    27. suffering from porphyria or acute porphyria in history
    28. severe liver failure (transaminase 3-fold elevated; CHILD stage C)
    29. severe renal insufficiency (GFR < 30 ml/min)
    30. rare hereditary fructose intolerance
    31. hypersensitivity to ranitidine, other H2 receptor antagonists or any of the other components (water for injection).
    32. hypersensitivity to the active substance dobutamine (as hydrochloride) or any of the other components (mannitol)
    33. mechanical obstruction of ventricular filling and/or discharge, such as pericardial tamponade, pericarditis constrictiva, hypertrophic obstructive cardiomyopathy, severe aortic stenosis
    34. hypovolemic conditions
    35. administration of MAO inhibitors
    36. unwillingness to store and share pseudonymous disease data during clinical trials
    37. person who is not able to recognise the nature, significance and scope of the clinical trial (AMG § 40 para. 1 sentence 3), accommodation in an institution by court order or official order (AMG § 40 para. 1 sentence 4)
    38. person who is dependent on the sponsor, investigator or the Enforcement Panel (AMG § 40 para. 1 sentence 3 no. 3 b) and c) AMG in connection with para. 1.61 of the ICH/GCP guideline Topic E6)
    1. Vorhofflimmern
    2. Schwerer Klappenfehler
    3. Positiv für HIV 1 und 2
    4. Positiv für Lues
    5. Aktive Hepatitis B/C
    6. Vorhergehende Herzinfarkte
    7. Ventrikelwanddicke ≤ 5 mm
    8. Ventrikelthrombus
    9. NT pro BNP ≤ 350 pg/ml
    10. Schwangerschaft und Stillzeit
    11. Weibliche Patienten im zeugungsfähgen Alter* es sei denn, dass die Patientin gewillt ist, eine hocheffektive Kontrazeption** für die Dauer der Studie anzuwenden
    * Weibliche Patient im zeugungsfähigen Alter sind Frauen, welche die Menarche durchlaufen haben und nicht postmenopausal oder permanent sterilisiert sind (z.B. Hysterektomie, bilaterale Salpingo-Oophorektomie).
    ** Hocheffektive Kontrazeption sind Methoden, welche eine Ausfallrate < 1 % pro Jahr haben, wenn sie korrekt und regelmässig angewendet werden und sind definiert als Pearl Index < 1 (z.B. hormonale Kontrazeption, Hormonspirale).

    12. Wechselwirkungen mit der Prüfmedikation
    13. Bekannte Allergien/Hypersensitivität gegen Prüfmedikation oder auch Hilfsstoffe der Arzneiform
    14. Vorhergehende Knochenmarkstransplantation
    15. Alkohol- oder Drogenmissbrauch innerhalb der letzten 6 Monate vor Studieneinschluss
    16. Positiver Befund einer aktiven Myokarditis
    17. Bestehende Krebserkrankung oder eine frühere Krebserkrankung innerhalb der letzten 5 Jahre (ausgeschlossen sind erfolgreich behandelte nicht metastatische Plattenepithelkarzinome der Haut)
    18. Signifikante Viruspersistenz von Coxsackievirus oder Echovirus, Adenoviren, humanen Cytomegaloviren, Epstein-Barr-Virus, humanem Herpesvirus 6, Borrelia Burgdorferi und Parvovirus B19 (Kopienzahl >800)
    19. Großer chirurgischer Eingriff oder große Verletzung in den letzten 14 Tagen
    20. Körpergewicht > 100 kg
    21. BMI ≥ 40 (morbide adipositas)
    22. Bekannte Autoimmunerkrankungen (z.B. Lupus, Multiple Sklerose)
    23. Diabetes Typ I und II (wenn HbA1c >7,5%)
    24. Überempfindlichkeitsreaktionen gegen Penicillin und Aminoglykosid-Antibiotika (Streptomycin)
    25. Überempfindlichkeitsreaktionen gegen Kontrastmittel (Sonovue)
    26. Überempfindlichkeit gegen Clemastin, andere Antihistaminika mit ähnlicher chemischer Struktur oder einen der anderen Inhaltsstoffe (Wasser für Injektionszwecke; Propylenglycol; Ethanol; Sorbitol; Natriumcitrat).
    27. Leiden unter Porphyrie oder Auftreten einer akuten Porphyrie in der Anamnese
    28. schwere Leberinsuffizienz (Transaminase 3fach erhöht; CHILD Stadium C)
    29. schwere Niereninsuffizienz (GFR < 30 ml/min)
    30. seltene hereditäre Fructose-Intoleranz
    31. Überempfindlichkeit gegen Ranitidin, andere H2-Rezeptor-Antagonisten oder einen der sonstigen Bestandteile (Wasser für Injektionszwecke).
    32. Überempfindlichkeit gegen den Wirkstoff Dobutamin (als Hydrochlorid) oder einen der sonstigen Bestandteile (Mannitol)
    33. Mechanische Behinderung der ventrikulären Füllung und/oder des Ausflusses, wie z. B. Perikardtamponade, Perikarditis constrictiva, hypertrophe obstruktive Kardiomyopathie, schwere Aortenstenose
    34. hypovolämische Zustände
    35. Gabe von MAO-Hemmstoffen
    36. Fehlende Bereitschaft zur Speicherung und Weitergabe pseudonymisierter Krankheitsdaten im Rahmen der klinischen Prüfung
    37. Person, die nicht in der Lage ist, Wesen, Bedeutung und Tragweite der klinischen Prüfung zu erkennen (AMG § 40 Abs.1 S. 3), Unterbringung in einer Anstalt auf gerichtliche oder behördliche Anordnung (AMG § 40 Abs. 1 S. 4)
    38. Person, die in einer Abhängigkeit zum Sponsor, Prüfer oder der Prüfstelle steht (AMG § 40 Abs. 1 S. 3 Nr.3 b) und c) AMG in Verbindung mit Abs 1.61 der ICH/GCP-Leitlinie Topic E6)
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints
    • Acute toxicity in the context of the CardAPcells therapy:
    i) Occurrence of pulmonary complications
    ii) Occurrence of immunological reactions leading to anaphylactic reactions, cardiovascular risk or any acute organ failure (those occur either due to immunological activity of cells or cell death including released cell content)
    • Chronic toxicity in the context of the CardAPcells therapy:
    i) Incidence of malignant diseases directly caused by the "CardAPcells" product

    • Akute Toxizität im Zusammenhang mit der Zelltherapie:
    i) Auftreten von pulmonalen Komplikationen
    ii) Auftreten von immunologischen Reaktionen, die zu anaphylaktischen Reaktionen oder Schock führen, unmittelbare kardiovaskuläre Gefährdung oder jegliches akutes Organversagen (wobei diese entweder durch die immunologische Aktivität der Zellen oder deren Tod und den demzufolge freigesetzten Zellinhalten herbeigeführt wurden)
    • Chronische Toxizität im Zusammenhang mit der Zelltherapie:
    i) Inzidenz von malignen Erkrankungen, direkt durch das Produkt „CardAPcells“ verursacht


    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety evaluation occurs during study investigation at day of cell injection day -1/0 until visit 6 (final study visit).
    Die Sicherheitsevaluation erfolgt während der Verlaufsuntersuchungen ab dem Tag der Zellinjektion Tag -1/0 bis zur Visite 6 (Abschlussuntersuchung).
    E.5.2Secondary end point(s)
    • Maintenance and stability of cardiac output capacity
    i. Development of load reserves
    ii. Development of NYHA-class, duration of NYHA-class without deterioration of NYHA-class
    iii. Cardiac output during 6 min walk test at the last study investigation
    iv. Development of ejection fraction in silence oriented at base value during cell therapy application

    Quality of life
    • Improvement of Minnesota Living with Heart Failure Questionnaire (MLHFQ) results and SF36 at end of study investigations
    • Erhalt und Stabilisierung der Herzleistungsfähigkeit
    i. Entwicklung der Belastungsreserven (eng: cardiac reserve)
    ii. Entwicklung der NYHA-Klasse, Dauer des Zeitraumes ohne Verschlechterung der NYHA-Klasse eines Patienten
    iii. Leistungsfähigkeit beim 6-Minuten-Gehtest bei der letzten Studienverlaufsuntersuchung
    iv. Entwicklung der Ruhe-EF, orientiert am Basiswert zum Zeitpunkt der Zellapplikation

    Lebensqualität
    • Verbesserung der Resultate beim Minnesota Living with Heart Failure Questionnaire (MLHFQ) und dem SF36 zum Abschluss des Zeitraumes der Studienverlaufsuntersuchungen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy evaluation occurs during study investigation at day of myocard biopsy 2,5 months prior to cell injection until visit 6 (final study visit).
    Die Evaluation sekundärer Parameter erfolgt während der Verlaufsuntersuchungen 2,5 Monate vor der Zellinjektion (-2,5 Monate, Tag der Myokardbiopsie) bis zur Visite 6 (Abschlussuntersuchung).
    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 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) 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 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 Yes
    E.8.1.7.1Other trial design description
    doppelarmig, Dosiseskalation
    double-armed, dose escalation
    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.8.3 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
    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 months5
    E.8.9.1In the Member State concerned days
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 No
    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 state18
    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
    Keine
    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 Decision2019-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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