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    Summary
    EudraCT Number:2010-024391-25
    Sponsor's Protocol Code Number:2010CLI01
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-12-31
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2010-024391-25
    A.3Full title of the trial
    A Multi-centre, double blind, randomized placebo controlled phase II study to assess the efficacy and safety of ASCT01 in Critical limb Ischemia Patients - SCILI
    A.3.2Name or abbreviated title of the trial where available
    SCILI
    A.4.1Sponsor's protocol code number2010CLI01
    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 SponsorXCell-Center 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 support
    B.4.2Country
    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 nameASCT01
    D.3.2Product code ASCT01
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraarterial 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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 placeboIntraarterial use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Critical Limb Ischemia Rutherford clas 4-6
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to compare the effects of treatment with ASCT01 in patients with an endstage Critical Limb Ischemia vs a placebo therapy.
    E.2.2Secondary objectives of the trial
    To assess the safety profile of ASCT01 during the study
    To document other efficacy parameters such as:
    a.major Amputations and wound healing
    Changes in:
    b. Ankle-Brachial Index (AB-index)
    c. Transcutaneous oxygen pressure (Tcp02)
    d. Quality of life (EQ-5D Questionnaire)
    e. Rutherford grade and stage
    f. Angiography
    g. Walking index in speed and distance without and with pain
    h. Wound healing
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A sub study is planned in order to further characterize ASCT01 and to investigate the possible correlation between the composition of ASCT01 and the biological effects of the product.
    The sub study will only be performed on ASCT01 samples left over after injection of ASCT01 containing at least 2 million CD34+, or on ASCT01 prepared from patients randomized in the placebo arm.
    The aim of the complementary characterization is to gain a better understanding on qualitative and quantitative entities present in ASCT01.
    At the end of the study (after the unblinding) the correlation between the composition of ASCT01 and the biological effect of the product will be investigated.
    E.3Principal inclusion criteria
    1. Patients in the age group of 18-75 yrs.
    2. Established CLI (confirmed by Rutherford 4 to 6 or Fontaine III-IV to the
    recommendations of the TASC) with infra-inguinal arterial occlusive
    disease
    3. Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or the absolute ankle blood
    pressure < 60 mm Hg or TcPO2 <20 mmHg without tissue loss or TcPO2
    <40 mmHg if there is tissue loss.
    4. No surgical or interventional option for revascularization and no response
    to best standard care delivered as confirmed by a vascular surgeon.
    5. No immediate life-threatening complication from CLI which would demand
    immediate amputation.
    6. Patients who are able to understand the requirements of the study, and
    willing to provide voluntary written informed consent, abide by the study
    requirements, and agree to return for required follow-up visits.
    7. Coagulation status aPTT within normal limits
    8. Sufficient number of stem cells isolated from bone marrow (> 2 million
    CD34+).
    9. Viability of isolated stem cells > 90%.
    E.4Principal exclusion criteria
    1. Acute life threatening complication of limb ischemia with the need for
    immediate limb amputation to avoid death or clinical deterioration
    2. Patients with documented terminal illness or cancer or any concomitant
    disease process with a life expectancy of less than 6 months.
    3. Patients with a history of severe alcohol or drug abuse within 3 months of
    screening.
    4. Known bone marrow diseases which preclude transplantation.
    5. End-stage renal failure on regular dialysis treatment
    6. Patients already enrolled in another investigational drug trial or completed
    within 3 months.
    7. Pregnancy.
    8. Patients tested positive for HIV 1, HCV, and/or HBV
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable is a major amputation (above the ankle) of the affected limb after 3 months or an unchanged critical limb ischemia of the affected limb after 3 months defined as less than 15% change in tcPO2 or ABI or absolute ankle pressure.
    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) 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 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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 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 state88
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 88
    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)
    If further treatment is necessary, the investigator will inform the patient's general practitioner (GP) at the end of the trial period (last patient last visit). The patient then be advised to visit the GP directly.
    All included patients will ultimately be treated with the stem cell transplantation if they request: The patient having received placebo will be offered to receive ASCT01 at the end of the study.
    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 Decision2011-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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