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    Summary
    EudraCT Number:2010-022153-42
    Sponsor's Protocol Code Number:ADVANCE
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-08-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-022153-42
    A.3Full title of the trial
    A phase II trial of safety and efficacy of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction – The ADVANCE Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized clinical study of stem cells taken from fat tissue in the experimental treatment of patients with myocardial infarction (heart attack)
    A.3.2Name or abbreviated title of the trial where available
    Advance
    A.4.1Sponsor's protocol code numberADVANCE
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01216995
    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 SponsorCytori Therapeutics, Inc
    B.1.3.4CountryUnited States
    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 supportCytori Therapeutics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytori Therapeutics
    B.5.2Functional name of contact pointNora Meskini, Associate Director Eu
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3223467205
    B.5.5Fax number+3223469332
    B.5.6E-mailnmeskini@cytori.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 nameadipose-derived regenerative cells
    D.3.2Product code ADRCs
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntracoronary use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with ST-elevation myocardial infarction after PCI with stent
    E.1.1.1Medical condition in easily understood language
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10028597
    E.1.2Term Myocardial infarction acute
    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 safety and efficacy of adipose-derived regenerative cells delivered via the intracoronary (IC) route in the treatment of patients with ST-elevation myocardial infarction (STEMI)
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    to enter
    E.3Principal inclusion criteria
    •ST-segment Elevation Myocardial Infarction (STEMI)Criteria:
    o Ischemic symptoms AND
    oECG:
    -Development of pathologic Q waves on the ECG; or

    -ECG changes indicative of severe ischemia (ST segment elevation and/or reciprocal depression); or

    - New left bundle branch block; AND
    - Creatine Phosphokinase Isoenzyme (MB Form) > 100 IU/L, or troponin >5x the upper limit of normal between admission and randomization

    • Successful revascularization of the culprit lesion in a major epicardial vessel (defined as the first sustained restoration of TIMI 3 flow) within 150 minutes to 12 hours from the time of symptom onset defined as:
    -TIMI 3 flow
    -No more than 10% residual stenosis, by online QCA or visual assessment
    -No dissection/haziness by completion of procedure
    -No residual clot
    -No MACCE during this hospitalization other than the MI for which the patient was admitted
    • No more than one intracoronary stent placed to treat the non bifurcating target lesion during the primary PCI, with one additional stent allowed to treat coronary dissection
    • Multi-vessel disease: patients with maximum of one additional, non-target lesion that must be in an epicardial vessel different from the target vessel can be included in the study. If the non-target lesion is treated during the PCI for AMI, then both lesions must meet criteria for successful revascularization in order for the patient to be eligible. If the non-target lesion is not treated during this procedure, the patient will be scheduled for treatment of non-target lesion no earlier than 7 months after the index procedure. Should non-target lesion require ischemia-driven revascularization, such procedure can be performed as needed, and the revascularization will not constitute a MACCE or target vessel failure (TVF) event.
    • Area of hypokinesia or akinesia corresponding to the territory of culprit lesion, as determined by left ventriculogram at the time of primary PCI, or left ventricular wall motion abnormalities (at least 2/18 segments) in the territory of the culprit lesion as assessed by 2D TTE
    • Hemoglobin and serum creatinine within normal limits between PCI and liposuction
    • Ability to undergo liposuction to obtain a minimum of 300 mL adipose tissue, as assessed by the physician performing the liposuction procedure
    E.4Principal exclusion criteria
    • More than 24 hours between PCI and start of liposuction
    • Clinically significant (greater than TIMI ‘minimal’ bleeding, per Appendix 11) vascular access site hematoma after PCI and before start of liposuction
    • Staged treatment of coronary artery disease beyond 1 single non-target lesion (as described above)
    • Malignant tumor
    • Acute or chronic bacterial or viral infectious disease
    • Pacemaker, ICD, or any other contra-indication for MRI
    • Severe COPD
    • Current need for mechanical ventilation at the time of planned liposuction
    • Cardiogenic shock present post-PCI
    • Prior MI, cardiomyopathy, or prior hospital admission for congestive heart failure
    • Prior ventricular fibrillation, or sustained ventricular tachycardia between hospital admission and randomization
    • Patients with increased bleeding risk including but not limited to:
    -Those who have received any glycoprotein IIb/IIIa inhibitor within seven days preceding the liposuction
    -Those who have received any anticoagulant within 1 hour prior to liposuction, or
    -Those who have an aPTT result of ≥ 1.8 times the control value 1 hour prior to liposuction – once aPTT returns to a documented value below 1.8 upper limit of normal, liposuction can start
    -Administration of a thrombolytic agent within the previous 24 hours
    • Hemodynamic instability within 8 hours prior to randomization, defined as the presence of any of the following:
    -Need for therapeutic doses of inotropic agent greater than 1 hour to maintain blood pressure above 90 mmHg before or after PCI
    -Systolic blood pressure <90 mmHg for more than 1 hour
    -Heart rate >110 bpm for more than 1 hour
    • Persistent atrial fibrillation (for MRI quality)
    • Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is absolute improvement in infarct size [expressed as percent of left ventricle infarcted (%LVI)] at 6 months post-index procedure as measured by gadolinium contrast cardiac MRI; i.e., change in 6-Month vs. Day 4 infarct size.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 Months
    E.5.2Secondary end point(s)
    • Reduction in Infarct Size at 12 months (MRI)
    • Major adverse cardiac or cerebral events (MACCE) rates at 1, 6, 12, 24, and 36 months. MACCE is a composite endpoint comprised of the following:
    -Cardiac death
    -Myocardial infarction (MI)
    -Overnight hospitalization for heart failure which requires administration of IV diuretics
    -Target lesion revascularization (TLR)
    -Target vessel revascularization (TVR)
    -Stroke
    • SPECT assessment of improvement in perfusion defect, LVEDV, LVESV, and LVEF at 6 and 12 months (measured by SPECT); subset of clinical sites as designated by the Sponsor
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 6, 12, 24 and 26 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 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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    prospective
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Switzerland
    United Kingdom
    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
    Enrollment of patients in the ADVANCE study may be terminated under the circumstances such as follows:
    • Interim analysis demonstrates futility or overwhelming efficacy
    • New safety information causes concerns about the study
    • DMC recommendation
    • Executive committee decision
    Any decisions on study termination will be recorded and promptly notified as outlined in ICH E6 Section 5.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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 Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.6.1Details of subjects incapable of giving consent
    The study population will consist of patients with STEMI who are undergoing PCI with stent placement between 2 ½ and 12 hours after onset of AMI. Cell injection should occur within 1-2 days after PCI.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 216
    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)
    The protocol is designed so that patient treatment and follow-up procedures will be consistent with those of the clinically established standard treatment options for the selected patient population; all patients will receive standard of care treatment
    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 Decision2010-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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