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    Summary
    EudraCT Number:2006-006404-11
    Sponsor's Protocol Code Number:PERFECT001(M-2006-144)
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2007-08-30
    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 ConcernedGermany - PEI
    A.2EudraCT number2006-006404-11
    A.3Full title of the trial
    INTRAMYOCARDIAL TRANSPLANTATION OF BONE MARROW STEM CELLS FOR IMPROVEMENT OF POST-INFARCT MYOCARDIAL REGENERATION IN ADDITION TO CABG SURGERY: a controlled prospective, randomized, double blinded multicenter trial
    Intramyokardiale Transplantation von Knochenmark-Stammzellen zur Verbesserung der myokardialen Regeneration nach Infarkt in Ergänzung zur Bypass-Operation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    After myocardial infarction patients suffer from insufficient blood and oxygen supply. This often results in a reduced heart function attributed to irreversible loss of viable cardiomyocytes. The aim of the study is to determine whether injection of the patient’s own bone marrow stem cells yields an additional benefit to coronary artery bypass graft (CABG) surgery.
    Patienten, die einen Herzinfarkt erlitten haben, leiden an ungenügender Blut- und Sauerstoffversorgung. Häufig führt dies zu einer reduzierten Herzfunktion in Folge des irreversiblen Verlustes an Herzmuskelzellen. Ziel dieser Studie ist es zu festzustellen, ob die Injektion der körpereigenen Knochenmarkstammzellen einen zusätzlichen Nutzen zur Bypass-Operation bewirken.
    A.3.2Name or abbreviated title of the trial where available
    PERFECT
    A.4.1Sponsor's protocol code numberPERFECT001(M-2006-144)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00950274
    A.5.4Other Identifiers
    Name:German Clinical Trials RegisterNumber:DRKS00000213
    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 SponsorMiltenyi Biotec GmbH
    B.1.3.4CountryGermany
    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 supportGerman Federal Ministry of Education and Research
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportMiltenyi Biotec GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMiltenyi Biotec GmbH
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressFriedrich-Ebert-Straße 68
    B.5.3.2Town/ cityBergisch Gladbach
    B.5.3.3Post code51429
    B.5.3.4CountryGermany
    B.5.6E-mailpetrah@miltenyibiotec.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 nameCD133+ autologous bone marrow stem cells
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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.3.9.3Other descriptive nameCD133+ enriched bone marrow stem cells
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100000 to 5000000
    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 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 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 placeboSuspension for injection in pre-filled syringe
    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
    Coronary artery disease after myocardial infarction with an indication for CABG surgery
    Koronare Herzerkrankung nach Myokardinfarkt mit der Indikation zur Bypass-Operation
    E.1.1.1Medical condition in easily understood language
    Patients suffering from a heart attack with reduced heart function who are in need of a bypass surgey in order to enhance oxygen supply of their heart
    Patienten, deren Herzfunktion nach erlittenem Herzinfarkt beeinträchtigt ist und die eine Bypass-Operation benötigen zur Verbesserung der Sauerstoffversorgung des Herzens
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10028596
    E.1.2Term Myocardial infarction
    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 determine whether injection of autologously derived bone marrow stem cells yields a functional benefit in addition to the coronary artery bypass graft (CABG) operation as determined by left ventricular heart function (LVEF-MRI)
    Es soll über die Messung der linksventrikulären Herzfunktion (LVEF), gemessen im MRT, nachgewiesen werden, dass die Injektion der autologen Knochenmarkstammzellen einen zusätzlichen positiven Funktions-Effekt im Vergleich zur Bypassoperation alleine bringt
    E.2.2Secondary objectives of the trial
    To determine the effects of an injection of autologously derived bone marrow stem cells on physical exercise capacity, cardiac function, safety and quality of life (QoL)
    Es sollen die Effekte der Injektion der autologen Knochenmarkstammzellen auf die körperliche Leistungsfähigkeit, die Herzfunktion, die Lebensqualität der Patienten und die Sicherheit der Anwendung nachgewiesen werden
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Coronary artery disease after myocardial infarction with indication for CABG surgery
    2. Currently reduced global LVEF assessed at site by cardiac MRI at rest (25% ≤ LVEF ≤ 50%)
    3. Presence of a localized akinetic/hypokinetic/hypoperfused area of LV myocardium for defining the target area
    4. Informed consent of the patient
    5.18 years ≤ Age < 80 years
    6. Are not pregnant and do not plan to become pregnant during the study. Females with childbearing potential must provide a negative pregnancy test within 1-7 days before OP and must be using oral or injectable contraception (non childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start).
    1. Verengung der Koronararterien nach Myokardinfarkt mit Indikation zur Bypass-Operation
    2. Reduzierte LVEF im Herz-MRT in Ruhe (25% ≤ LVEF ≤ 50%)
    3. Lokalisierung von akinetischen / hypokinetischen / minder durchbluteten Gebieten des (LV) Myokards zur Definition des Zielbereichs
    4. Einwilligung des Patienten
    5. 18 Jahre ≤ Alter < 80 Jahre
    6. Frauen, die in die Studie eingeschlossen werden, sind nicht schwanger und planen auch nicht schwanger zu werden während der Studie. Frauen im geburtsfähigen Alter müssen einen negativen Schwangerschaftstest 1-7 Tage vor der OP haben und müssen eine orale oder injektable Kontrazeption nutzen. Nicht geburtsfähiges Alter ist als post-menopausal für wenigstens 1 Jahr, chirurgische Sterilisation oder Hysterektomie wenigstens 3 Monate vor Studienbeginn definiert.
    E.4Principal exclusion criteria
    Patients will be entered into this study only if they meet none of the following criteria:
    1. Emergency operation
    2. Presence of any moderate-severe valvular heart disease requiring concomitant valve replacement or reconstruction
    3. Medical History of recent resuscitation in combination with ventricular arrhythmia classified by LOWN ≥ class II
    4. Acute myocardial infarction within last 2 weeks
    5. Debilitating other disease: Degenerative neurologic disorders, psychiatric disease, terminal renal failure requiring dialysis, previous organ transplantation, active malignant neoplasia, or any other serious medical condition that, in the opinion of the investigator is likely to alter the patient’s course of recovery or the evaluation of the study medication’s safety
    6. Impaired ability to comprehend the study information
    7. Absence of written informed consent
    8. Treatment with any investigational drug within the previous 30 days
    9. Apparent infection (c-reactive protein [CRP] ≥ 20 mg/L, fever ≥ 38.5°C)
    10. Contraindication for MRI scan
    11. Immune compromise including active infection with Hepatitis B, C, HIV virus or seropositivity for Treponema pallidum
    12. Pregnant or breast feeding
    13. Childbearing potential with unreliable birth control methods
    14. Have previously been enrolled in this study, respectively phase I and phase II
    15. Known hypersensitivity or sensitization against murine products and human-anti-mouse-antibody-titer ≥ 1:1000.
    16. Contraindication to bone marrow aspiration
    17. Known hypersensitivity against iron dextrane
    1. Notfalloperation
    2. Anwesenheit irgendeiner Herzklappenerkrankung, die Ersatz oder Rekonstruktion erfordert
    3. Kürzlich erfolgte Reanimation in Kombination mit ventrikulärer Arrhythmie der Einstufung LOWN ≥ Klasse II in der Anamnese
    4. Akuter Myokardinfarkt in den letzten 2 Wochen
    5. Schwächende andere Erkrankungen, wie degenerative neurologische Erkrankungen, psychiatrische Erkrankungen, eine terminale Nierenerkrankung, die eine Dialyse erfordert, vorangegangene Organtransplantation, aktive maligne Neoplasie oder jede andere ernsthafte Erkrankung, die nach Meinung des Investigators die Sicherheit des Patienten während der Studie gefährden könnte.
    6. Eingeschränkte Fähigkeiten die Studieninformation zu verstehen
    7. Abwesendheit einer schriftlichen Einwilligung
    8. Behandlung in irgendeiner anderen Studie in den letzten 30 Tagen
    9. Klinisch-manifeste Infektion (CRP ≥ 20 mg/L, Temperatur ≥ 38.5°C)
    10. Kontraindikation für MRT
    11. Immunschwäche inklusive aktive Infektion mit Hepatitis B, C, HIV Virus oder Seropositivität fürAnti-HIV 1/2, HBsAg, Anti-HCV, Anti-HBc-IgG, Treponema pallidum
    12. Schwangerschaft oder Stillzeit
    13. Geburtsfähiges Alter mit unzureichender Verhütungsmethode
    14. Einschluss in Phase I oder II
    15. Bekannte Hypersensibilisierung oder Sensibilisierung gegen mausartige Produkte und Human-anti-mouse-antibody-titer ≥ 1:1000
    16. Kontraindikation für Knochenmarkaspiration
    17. Bekannte Hypersensibilisierung gegen Eisen-Dextrane
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is LVEF at 6 months postoperatively, measured by MRI at rest. Cardiac MRI is established as the gold standard for determination of LV function (LVEF and LV volumes).
    Der primäre Endpunkt ist die LVEF 6 Monate nach der Operation, gemessen im MRT in Ruhe. Das Herz-MRT ist als Goldstandard zur Bestimmung der LV-Funktion (LVEF und LV-Volumen) etabliert.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months postoperatively
    6 Monate nach Bypass-Operation
    E.5.2Secondary end point(s)
    1. Change in LVEF at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge) as assessed by MRI and echocardiography.
    2. Change in LV dimensions (left ventricular end systolic dimension [LVESD], left ventricular end diastolic dimension [LVEDD]) at 6 month post-OP compared with preoperatively (screening) and early postoperatively (discharge) as assessed by echocardiography.
    3. Change in physical exercise capacity determined by 6 minute walk test at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge).
    4. Change in NYHA and CCS class at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge).
    5. MACE (cardiac death, myocardial infarction, secondary intervention/reoperation, ventricular arrhythmia).
    6. QoL-score at 6 months post-OP compared with preoperatively (screening) and 3 months (telephone).
    1. Veränderungen bei der LVEF 6 Monate nach der OP im Vergleich zu Prä-OP und Früh-Post-OP gemessen im MRT und der Echokardiographie.
    2. Veränderungen in der LV-Dimension (linksventrikuläre endsystolische Dimension [LVESD], linksventrikuläre enddiastolische Dimension [LVEDD]) 6 Monate nach der OP im Vergleich zu Prä-OP und Früh-Post-OP gemessen in der Echokardiographie.
    3. Veränderungen in der körperlichen Leistungsfähigkeit 6 Monate nach der OP gemessen mit dem 6-Minuten-Gehtest im Vergleich zu Prä-OP und Früh-Post-OP.
    4. Veränderungen bei NYHA und CCS 6 Monate nach der OP im Vergleich zu Prä-OP und Früh-Post-OP.
    5. MACE (Herztod, Myokardinfarkt, Reintervention, Reoperation, ventrikuläre Arrhythmien).
    6. QoL-Score 6 Monate nach der OP im Vergleich zu Prä-OP und nach 3 Monaten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Early postoperatively (hospital discharge)
    At 3 months postoperatively
    At 6 months postoperatively
    Früh-Post-OP (Hospital-Entlassung)
    3 Monate nach Bypass-Operation
    6 Monate nach Baypass-Operation
    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 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 concerned7
    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
    The study will close when all patients have completed the Final Follow-up Assessment (Assessment V) 6 month after OP.
    Die Studie wird beendet sein, wenn alle Patienten die finale Nachsorgeuntersuchung (Assessment V) 6 Monate nach Bypass-Operation abgeschlossen haben
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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.1.1Number of subjects for this age range: 0
    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: 142
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 142
    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 state142
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 142
    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)
    After participation in the trial subjects will undergow follow up analysis in yearly intervals (MACE and NYHA). 2 years after operation all safety parameters will be checked and documented in the frame of pharmacovigilance.
    Nach Studienende werden alle Patienten in die Nachsorge gehen (MACE und NYHA). 2 Jahre nach Bypass-Operation werden sicherheitsrelevante Paramenter überprüft und dokumentiert im Rahmen der Pharmokovigilanz
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation not applicable
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-18
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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