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    Summary
    EudraCT Number:2009-013103-63
    Sponsor's Protocol Code Number:1884
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-04-21
    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 number2009-013103-63
    A.3Full title of the trial
    Pilot study investigating the effect of intra-coronary and intra-myocardial application of enriched CD133pos autologous bone marrow derived stem cells for improving left ventricular function in chronic ischemic cardiomyopathy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study compares two different delivery routes of stem cells in patients with chronic ischemic cardiomyopathy. "Ischemic" means not enough blood and oxygen. "Cardio" means heart and "myopathy" muscle-related disease. Patients in the study suffer from loss of contractile force. CD133pos autologous stem cells are a particularly prepared subpopulation of stem cells implemented in order to support cardiac restoration.
    A.3.2Name or abbreviated title of the trial where available
    AlsterMACS
    A.4.1Sponsor's protocol code number1884
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01337011
    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 SponsorAsklepios Kliniken Hamburg GmbH
    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 supportAsklepios Kliniken Hamburg GmbH
    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 organisationAsklepios proresearch
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressLohmuehlenstrasse 5
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20099
    B.5.3.4CountryGermany
    B.5.4Telephone number00490401818853160
    B.5.5Fax number00490401818853159
    B.5.6E-mailinfo.proresearch@asklepios.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 nameCD133+ autologous bone marrow stem cells
    D.3.2Product code CD133+ autologous stem cells
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    Intramuscular 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) 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 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 chronic ischemic cardiomyopathy with an LVEF ≤45% and symptomatic heart failure NYHA ≥ II under optimal therapy and drug treatment according to the current ESC heart failure guidelines.
    E.1.1.1Medical condition in easily understood language
    Patients with heart failure (NYHA ≥ II defines the stage according to the New York Heart Association) and have a left ventricular ejection fraction ≤45% although on optimal medication.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    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
    To assess the safety, feasibility, and efficacy of intra-myocardial as well as intra-coronary CD133pos. BM cell therapy on left ventricular ejection fraction as measured by echocardiography.
    E.2.2Secondary objectives of the trial
    The intra-coronary delivery of CD133pos cells and the intra-myocardial application via the NOGA system are equally effective regarding the following parameters after 6 and 12 months compared to baseline:
    - improvement of LV function as measured by cardiac MRI,
    - a decrease in BNP,
    - an increase in 6min walk test and
    - an increase in peak oxygen consumption.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients 18 to 80 years old
    • of female and male gender
    • Patient has reduced ejection fraction as evaluated by routine clinical angiogramm,
    echocardiography or MRI (≤45%) due to ischemic heart disease
    • symptomatic heart failure NYHA ≥ II on optimal therapy
    • coronary artery in the target region that can be used for cell infusion
    • Patient has been informed of the nature of the clinical trial and agrees to its provision and
    has provided written informed consent
    E.4Principal exclusion criteria
    • planned or performed CABG surgery or PCI within 4 weeks of study entry
    • recent myocardial infarction (< 6 months)
    • TIMI flow < II in the coronary artery selected for infusion
    • cardiogenic shock requiring mechanical ventilation or intra-aortic balloon pump
    • progressive tumor disease
    • primary disease of bone marrow including mal-function of components of the coagulation
    system
    • women of child-bearing age premenopausal
    • LV wall thickness < 5mm at planned site of injection
    • ventricular wall thrombus
    • severe aortic valvular heart disease
    • severe atrial or ventricular tachycardia unresponsive to intravenous or oral drug therapy
    • aneurysm of the anterior wall
    • history of stroke
    • know diseases of the liver resulting in reduced plasmatic coagulation with spontaneous INR
    >2
    • patients with chronic infectious diseases (HBV, HCV, HIV)
    • patients taking part or have taken part in other clinical trials within the past 3 months
    • patients unable to provide informed consent
    • any other medical condition that the enrolling physician deems significant in representing a
    potential hazard for the patient when participating in this study
    E.5 End points
    E.5.1Primary end point(s)
    In patients with chronic ischemic cardiomyopathy with an ejection fraction of ≤45% and heart failure symptoms ≥ NYHA II despite optimal therapy, the application of 0,1-5 x 10e6 CD133pos cells isolated from 100-150ml of bone marrow aspirate via the intra-coronary route as well as via NOGA-guided intra-myocardial cell delivery system leads to a significant improvement in left ventricular global ejection fraction measured via echocardiography compared to baseline at 6 months. Significant improvement is defined by an absolute increase of LVEF of 5%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 6 months
    E.5.2Secondary end point(s)
    The intra-coronary delivery of CD133pos cells and the intra-myocardial application via the NOGA system are equally effective regarding the following parameters after 6 and 12 months compared to baseline:
    - improvement of LV function as measured by cardiac MRI,
    - a decrease in BNP,
    - an increase in 6min walk test and
    - an increase in peak oxygen consumption.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 3,6 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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    intra-myocardial vs. intra-coronary application
    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 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
    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 months0
    E.8.9.1In the Member State concerned days0
    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.1.3Elderly (>=65 years) Yes
    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 state64
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 64
    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)
    Annual Follow-Up Telephone Calls will be done for four years, in which data on survival, hospitalization because of heart failure and concomitant medication will be collected.
    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 Decision2011-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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