Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2007-000339-24
    Sponsor's Protocol Code Number:APOLLO_01
    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:2007-04-19
    Trial results Removed from public view
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2007-000339-24
    A.3Full title of the trial
    A randomized clinical trial of AdiPOse-derived stem ceLLs in the treatment of patients with ST elevation myOcardial infarction – The APOLLO Trial
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberAPOLLO_01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntracardiac use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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) Information not present in EudraCT
    D. cell therapy medicinal product Yes
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboIntracardiac 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
    MedDRA Classification
    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 feasibility of adipose-derived stem cells delivered via the intracoronary (IC) route in the treatment of patients with ST-elevation myocardial infarction (STEMI) at 6 months
    E.2.2Secondary objectives of the trial
    Additional assessments of left ventricular function will be performed at 12, 18, 24, and 36 months after the procedure.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Able to provide informed consent
    2.Males or females 20 to 85 years of age, inclusive
    3·Clinical symptoms consistent with AMI (pain, etc.) for a minimum of 2 and a maximum of 12 hours from onset of symptoms to PCI, and unresponsive to nitroglycerin
    5·Anterior AMI: ·≥ 0.2 mV ST elevation in 2 or more V1 – V6 leads AND interval complaints and first contact < 12 hours or
    6·Inferior AMI:≥ 0.1 mV ST elevation in 2 or more leads II, III, aVF AND interval complaints and first contact < 12 hours or
    7·New left bundle branch block:
    with interval symptoms and first contact < 12 hours or
    8·Cardiac enzymes:
    Two times the upper limit of normal of creatine kinase with an abnormal level of creatine kinase MB fraction
    9·Successful revascularization of the culprit lesion in the major epicardial vessel within 12 hours of the onset of AMI symptoms (defined as (1) primary or facilitated PCI with stent implantation, resulting in TIMI 3 flow AND (2) residual stenosis no more than 10% by visual assessment or no more than 20% by on-line QCA)
    10·Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI
    11·Left ventricular ejection fraction (LVEF) ³30% and £50%; as determined by left ventricular angiography after PCI. LVEF may be assessed by echocardiography if the left ventricular angiogram is not analyzable or available.
    12·Ability to undergo liposuction
    13·Negative urine pregnancy test (females only).
    E.4Principal exclusion criteria
    1·Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF)
    2·More than 24 hours after acute PCI
    3·Significant valvular disease
    4·More than 12 or less than 2 hours between the onset of first symptoms of AMI and revascularization, defined as restoration of at least TIMI 3 flow
    5·Inability to complete ADRC infusion within 24 hours of PCI
    6·Staged treatment of coronary artery disease, or other interventional or surgical procedures to treat heart disease (e.g., valve replacement, PCI or CABG) planned or scheduled within 6 months after the study procedure
    7·Need for mechanical ventilation
    8·Cardiogenic shock
    9·Hemodynamic instability within 24 hours prior to randomization, defined as the presence of any of the following:
    10·Need for inotropic support
    11·Systolic blood pressure <90 mmHg
    12·Heart rate >100 bpm for more than 1 hour
    13·Prior ventricular fibrillation or sustained ventricular tachycardia
    14·Persistent atrial fibrillation
    16·Acute or chronic bacterial or viral infectious disease
    17·Pacemaker, ICD or any other contra-indication for MRI
    18·LVEF <30% or >50% as determined by left ventriculogram at the time of primary PCI
    19·Moderate or severe COPD (refer to Appendix 16 for classification codes)
    20·Pregnant and/or nursing females
    21.Known relevant allergies or sensitivities
    22·Serum creatinine >2.0 mg/dL
    23·Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient’s participation in this study
    24·Life expectancy <1 year
    25·Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.

    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints will be assessed at 30 days, and at 3, 6, 12, 18, 24, and 36 months post procedure:
    ·Major adverse cardiac or cerebral event (MACCE) rates
    ·Serious adverse events (SAEs) / adverse events (AEs) rates
    ·Composite clinical endpoint: death, MI, stroke
    ·Re-hospitalization for heart failure
    ·Angina pectoris as defined by Canadian Cardiovascular Society (CCS) & Braunwrad Classifications
    ·New York Heart Association (NYHA) Class
    ·Continuous Electrocardiographic monitoring for 6 days following procedure (72 hours by telemetry and 72 hours by Holter monitor), then weekly for the first four weeks (for 48 hours) and at 2 , 3, 4 , 6, 12, 18, 24 and 36 months (for 24 hours).

    Feasibility endpoints will be assessed at the time points specified in Appendix 17 and include the following:
    ·Absolute LVEF and change in LVEF from baseline to six months (by 2D & 3D echocardiography, LV angiography and MRI 17-segment AHA model)
    ·MI size (by delayed enhancement in MRI 17-segment AHA model)
    ·Regional wall thickness and thickening in all segments including infarct area (by MRI 17-segment AHA model)31
    ·LV-ESV and LV-EDV (by MRI 17-segment AHA model)
    ·Absolute and change in perfusion defect after revascularization to six months (by SPECT imaging)
    ·Wall Motion Score Index (by 2-D echocardiography).

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 Information not present in EudraCT
    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
    Primary outcomes of this trial will be assessed at six (6) months post index procedure. After the 6-month assessments, long-term patient follow up will continue for an additional 30 months.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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 Decision2007-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands