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    Summary
    EudraCT Number:2008-005594-35
    Sponsor's Protocol Code Number:TJB0603
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-08-06
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-005594-35
    A.3Full title of the trial
    Randomized double-blind study of mesenchymal stem cells (MSC) in patients undergoing matched unrelated allogeneic bone marrow or peripheral blood stem cell transplantation- A European multicentre study.
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberTJB0603
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 SponsorCHU Sart-Tilman
    B.1.3.4CountryBelgium
    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 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 nameMesenchymal stem cells
    D.3.2Product code MSC
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hematological disorders of the following types:
    ALL: acute lymphoblastic leukemia in complete remission (<5% blasts in marrow) up to and including third remission (excluding relapse).
    AML: acute myelocytic leukemia in remission (excluding relapse).
    CML: chronic myelocytic leukemia who are in the chronic phase of the disease.
    Severe aplastic anemia, hemoglobinopathies (thalassemia major).
    Inborn errors of metabolism.
    Myelodysplastic syndromes
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027703
    E.1.2Term Mismatched donor bone marrow transplantation therapy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to evaluate the functioning of mesenchymal stem cells (MSC) in supporting hematopoietic cells transplantation (HSC).
    Cotransplantation of MSC with HSC may be beneficial by preventing rejection, decreasing graft-versus-host disease, enhancing engraftment and preventing tissue toxicity by chemoirradiation.
    GvDH incidence (acute grade II-IV GvDH) will be used as measure of efficacy.
    E.2.2Secondary objectives of the trial
    1. Determination of time to neutrophil engraftment (>0.5 x 10E9/l).
    2. Determination of time to platelet engraftment (>30 x 10E9/l).
    3. Platelet level at day 30 post transplant.
    4. Transfusions during first 30 days.
    5. Incidence of chronic GvHD.
    6. Treatment-related mortality (causes of death).
    7. Overall relapse rate.
    8. Survival.
    9. Disease-free survival.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient inclusion criteria
    1. Informed consent.

    2. Patients/subjects are required to meet the following inclusion criteria:
    a. Hematological disorders of the following types:
    ALL: patients with acute lymphoblastic leukemia in CR (<5% blasts in marrow) up to and including third remission (excluding relapse),
    AML: patients with acute myelocytic leukemia in remission,
    CML: patients with chronic myelocytic leukemia who are in the chronic phase of the disease,
    Severe aplastic anemia, hemoglobinopathies (thalassemia major), inborn errors of metabolism.
    MDS
    b. Patients may have undergone myeloablative or reduced intensity conditioning regimen.
    c. Use of anti-thymocytes globulin (ATG) during conditioning, according to the routine at each center. Both arms must be treated identically at each center.

    3. Adequate cardiac function. Left ventricular ejection fraction or megascan or echocardiography must be at least 40% of predicted.

    4. Adequate pulmonary function as defined as no severe or symptomatic restrictive or obstructive lung disease. FEV-1 >50% of predicted and DLCO >50% of predicted.

    5. Female patients are non-pregnant.

    6 Patients must be HIV-1 and –2 antibody, HIV -1 antigen and hepatite A, B and C seronegatives.

    7. Patients must have a Karnofsky score of =70.

    8. Patients must have an HLA-A, -B and -DRß1 identical stem cell donor.
    (HLA typing according to the routine at each center).

    9. Immunosuppression should consist of cyclosporine or tacrolimus combined with four doses of methotrexate. Methotrexate is given on day+1, 15 mg/m2 and 10 mg/m2 on days +3, +6 and +11 after transplantation. Cyclosporine or tacromilus dose is according to the routines at each center. Because acute GvHD is a primary endpoint, no other immunosuppression than cyclosporine combined with methotrexate will be allowed.

    Donor inclusion criteria
    1. MSC donor must be HIV, HB-s antigen, anti HBc and anti HCV negative.

    2. Related haploidentical or HLA mismatched MSC donor willing to donate MSC

    3. Signed informed consent.

    4. Each center request either bone marrow or peripheral blood stem cells according to routine at each center. If the donor only accepts one type of donation, he/she may be included anyhow.
    E.4Principal exclusion criteria
    Patient exclusion criteria
    1. Hematologic malignancies, of the following types
    a) ALL patients in relapse as defined by >5% blasts in the marrow and/or circulating blasts in the peripheral blood,
    b) AML patients in relapse as defined by >5% blasts in the marrow.
    c) AML/ALL CR4 or later.
    d) CML in accelerated phase or blast crisis.
    e) MDS > RAEB II.

    2. Patient has active alcohol or substance abuse.

    3. Patient has a medical condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient.

    4. Patient needing hematopoietic stem cell transplantation within three weeks.

    5. Patient with a history of hyper-sensitivity to penicillin

    Donor exclusion criteria
    1. Donor more than 65 years of age, or unhealthy.

    2. Donor positive for HIV, HTLV, hepatitis Bs antigen, anti-HCV or anti-
    HBc.
    E.5 End points
    E.5.1Primary end point(s)
    To establish the efficacy of infusions of identical, haploidentical or mismatched related or unrelated MSC in matched unrelated donor allogeneic hematopoietic stem cell transplantation of patients with hematologic malignancies and inborn errors of metabolism. GvHD incidence (acute grade II-IV GvDH) will be used as measure of efficacy.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) 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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    This study may be terminated, if for the investigator, there is sufficient reasonable cause. Circumstances that may warrant termination include:
    Determination of unexpected, significant, or unacceptable risk to patients. Failure to enter patients at an acceptable rate. Insufficient adherence to protocol requirements. Insufficient complete and/or evaluable data. Protocol violation. Administrative decision. New data able to influence the willingness of the investigators to pursue the study.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 172
    F.4.2.2In the whole clinical trial 172
    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 Decision2009-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-08-23
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