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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

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    Summary
    EudraCT Number:2018-004563-31
    Sponsor's Protocol Code Number:Au18-12
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-004563-31
    A.3Full title of the trial
    Cell therapy in Critical Limb Ischemia by implantation of allogeneic umbilical cord-derived mesenchymal stem cells
    Thérapie cellulaire allogénique de l’ischémie critique des membres inférieurs par implantation de cellules souches mésenchymateuses de cordon ombilical.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cell therapy in Critical Limb Ischemia by implantation of allogeneic umbilical cord-derived mesenchymal stem cells
    Thérapie cellulaire allogénique de l’ischémie critique des membres inférieurs par implantation de cellules souches mésenchymateuses de cordon ombilical.
    A.3.2Name or abbreviated title of the trial where available
    CLI
    CLI
    A.4.1Sponsor's protocol code numberAu18-12
    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 SponsorCentre Hospitalier Universitaire de Reims
    B.1.3.4CountryFrance
    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 supportCentre Hospitalier Universitaire de Reims
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Universitaire de Reims
    B.5.2Functional name of contact pointPr Ambroise DUPREY
    B.5.3 Address:
    B.5.3.1Street AddressService de chirurgie vasculaire - CHU de Reims
    B.5.3.2Town/ cityREIMS
    B.5.3.3Post code51092
    B.5.3.4CountryFrance
    B.5.4Telephone number0033326784670
    B.5.5Fax number0033326784662
    B.5.6E-mailaduprey@chu-reims.fr
    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 nameSuspension of allogeneic MSC from umbilical cord for treatment of Critical Limb Ischemia
    D.3.2Product code HBMSC1
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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) No
    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 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 Yes
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Evaluation of the feasibility and systemic and local tolerance of an implantation, via intramuscular route, of allogenic HB-MSC1, associated with a revascularization procedure, in patients suffering from critical limb ischemia (CLI).
    E.1.1.1Medical condition in easily understood language
    Preliminary evaluation of efficacy and dose effect relationship of the MSC implantation in hemodynamic, anatomical and functional terms.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    Evaluation of the feasibility and systemic and local tolerance of an implantation, via intramuscular route, of allogenic HB-MSC1, associated with a revascularization procedure, in patients suffering from critical limb ischemia (CLI).
    E.2.2Secondary objectives of the trial
    Preliminary evaluation of efficacy and dose effect relationship of the MSC implantation in hemodynamic, anatomical and functional terms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient is suffering from critical limb ischemia and is being subject to a revascularization procedure, associated or not to minimally invasive surgery,
    2. The patient (or his/her legal representative(s)) is capable to understand and comply with study requirements and to provide written informed consent prior to any study procedure for participation in the study and transmission of personal "anonymized" data, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form (ICF).
    3. Male or female patients aged ≥18 years at the time of signing the ICF.
    4. A female patient is eligible to participate if she is of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) will be required to use one of the treatment methods that does not modify hemostasis parameters (eg chlormadinone acetate [Lutéran]) or must discontinue HRT to allow confirmation of post-menopausal status prior to being enrolled in the study.
    5. Diabetic patients with an eye fundus examination of less than 3 months excluding proliferative retinopathy
    6. Patient with a life expectancy >12 months
    1. Patients souffrant d'ischémie critique des membres inférieurs et relevant d’une procédure de revascularisation par voie endovasculaire sous-inguinale, associée ou non à une chirurgie minimalement invasive.

    2. Le sujet (ou son / ses représentant (s) légal (aux)) est capable de comprendre et de satisfaire aux exigences de la recherche, de donner son consentement éclairé écrit pour participer à la recherche et d’autoriser la transmission de données personnelles “anonymisées”, ce avant toute procédure prévue par la recherche, ce qui signifie son accord pour participer à la recherche et se conformer aux restrictions et exigences énumérées dans le formulaire de consentement éclairé (FCE).

    3. Hommes ou femmes âgés de 18 ans et plus au moment de la signature du FCE.

    4. Une patiente féminine est éligible si elle n’est pas en état de procréer, à savoir qu’elle est une femme pré-ménopausée ayant subi une ligature des trompes ou une hystérectomie documentées ; ou post-ménopausée définie comme présentant 12 mois d'aménorrhée spontanée. Les femmes sous traitement hormonal substitutif (THS) devront utiliser l'une des méthodes de traitement qui ne modifient pas les paramètres d'hémostase (par ex. acétate de chlormadinone [Lutéran]) ou interrompre le THS pour confirmer leur statut post-ménopausique avant l’inclusion dans l'étude.

    5. Patients diabétiques disposant d’un examen de fond d'œil inférieur à 3 mois, excluant une rétinopathie proliférative.

    6. Patients dont l’espérance de vie est > 12 mois
    E.4Principal exclusion criteria
    1. Patients presenting a failure of the revascularization procedure
    2. The patient has, or has a history of, any significant disease or disorder that would increase the risk for the patient if they were enrolled in the study or would affect study procedures or outcomes.
    3. The patient is mentally or legally incapacitated.
    4. Patient protected by law.
    5. Patient who does not benefit from the national health insurance coverage.
    6. The patient has been involved in a previous trial with the investigational product.
    7. History of cancer excepting basocellular epithelioma during the past 5 years.
    8. Patient necessitating chronic hemodialysis or creatinine clearance inferior to 30 mL/min.
    9. History of stroke or myocardial infarction of less than 3 months.
    10. Hemostasis disorder with contra-indication of intramuscular injections.
    11. Patients receiving dual antiplatelet therapy that cannot be temporarily discontinued at least 4 days before and until 6 hours after cell implantation.
    12. Patient receiving an antiplatelet therapy with an adenosine diphosphate receptor inhibitor (ADP/P2Y12 inhibitor) that cannot be temporarily discontinued at least 4 days before and until 6 hours after cell implantation.
    13. Patient receiving an anticoagulant treatment that cannot be temporarily discontinued until 2 days after the study treatment injection.
    14. Patients subject to a below the knee femoro-popliteal bypass procedure or to a femoro-tibial bypass procedure
    15. Patients included in another therapeutic trial
    1. Patient présentant un échec de la procédure de revascularisation
    2. Patient ayant des antécédents ou présentant une maladie ou des troubles importants susceptibles d’augmenter le risque pour le sujet s’il était inclus dans l’étude, ou susceptibles d’avoir une incidence sur les procédures ou les résultats de l’étude.
    3. Patient atteint d'incapacité mentale ou juridique.
    4. Patient protégé par la loi.
    5. Patient ne bénéficiant pas d’une prise en charge par l’assurance maladie.
    6. Patient ayant participé à un essai précédent avec le produit expérimental.
    7. Patient ayant des antécédents de cancer, sauf épithélioma basocellulaire, durant les 5 années précédentes.
    8. Patient en hémodialyse chronique ou présentant une clairance de la créatinine inférieure à 30 mL / min.
    9. Patient ayant des antécédents d'AVC ou d'infarctus du myocarde au cours des 3 derniers mois.
    10. Patient présentant des troubles de l'hémostase avec contre-indication aux injections intramusculaires.
    11. Patients recevant une double antiagrégation plaquettaire ne pouvant être discontinuée de façon temporaire au moins 4 jours avant et jusqu’à 6 heures après l’implantation du médicament cellulaire expérimental.
    12. Patient recevant un traitement antiplaquettaire par un inhibiteur du récepteur de l'adénosine diphosphate (inhibiteur de l'ADP / P2Y) de façon temporaire au moins 4 jours avant et jusqu’à 6 heures après l’implantation du médicament cellulaire expérimental.
    13. Patient recevant ou devant recevoir un traitement anticoagulant qui ne peut être discontinué de façon temporaire jusqu’à 2 jours après l’implantation du médicament cellulaire expérimental.
    14. Patients soumis à un pontage fémoro-poplité sous le genou ou à un pontage fémoro-tibial.
    15. Patients inclus dans un autre essai thérapeutique.
    E.5 End points
    E.5.1Primary end point(s)
    Criteria for safety: Tolerance will be evaluated over the study follow-up:
    - Local tolerance: inflammation, pain, or any other unexpected symptom,
    - Systemic tolerance: pulse, arterial pressure, fever or any other abnormal symptom,
    - Biological tolerance,
    - Adverse events (AEs) and serious adverse events (SAEs),
    - Vital signs.

    The primary safety endpoint will be the occurrence of any high grade AEs (grade 2 and more), either serious or not, assessed as related to the cell implantation by the investigator, reported over the 360 days of the study period.
    Critères de tolérance : la tolérance sera évaluée sur toute la durée de l’étude.
    - Tolérance locale : inflammation, douleur ou tout autre symptôme inattendu
    - Tolérance systémique : pouls, pression artérielle, fièvre ou tout autre symptôme anormal
    - Tolérance biologique
    - Evénements indésirables (EI) et événements indésirables graves (EIG)
    - Signes vitaux.

    Le critère principal d'évaluation de la tolérance sera la survenue d' effets indésirables de haut grade (grade 2 et plus), graves ou non, évalués par l'investigateur comme étant liés à l'implantation cellulaire et rapportés au cours des 360 jours de la période d'étude.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months
    A 6 mois
    E.5.2Secondary end point(s)
    Assessment of preliminary efficacy is a secondary objective of the study.
    Primary efficacy endpoint: transcutaneous oxygen pressure (TcPO2)
    Secondary efficacy endpoints:
    - Hemodynamic endpoints: toe pressure, ankle pressure, ankle brachial index (ABI),
    - Functional endpoints: pain at rest, trophic disorders, ulcers,
    - Anatomical endpoints: Doppler ultrasound assessing permeability, thrombosis and restenosis of revascularization,
    - Clinical events: target limb re-intervention, minor or major target limb amputation, death of any cause.
    Critère principal d'efficacité : pression transcutanée en oxygène (TcPO2)
    Critères d'efficacité secondaires :
    - Critères hémodynamiques : pression à l’orteil, pression à la cheville, index de pression systolique (IPS)
    - Critères fonctionnels : douleur au repos, troubles trophiques, ulcères
    - Critères anatomiques : échographie Doppler évaluant la perméabilité, la thrombose et la resténose de la revascularisation,
    - Evénements cliniques: revascularisation du membre cible, amputation mineure ou majeure du membre cible, décès de toute cause.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 12 months
    A 12 mois
    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 Yes
    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) 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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    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
    Endpoints are mesured at 12 months and that is the end of the trial. Included patients are follow up in the next 12 months in a cohort study to evaluate the safety on greater period
    Les critères de jugement sont mesurés à 12 mois et c'est la fin de l'essai clinique. Les patients inclus seront néanmoins suivis dans les 12 mois suivants et surveillés en terme de tolérance et d'efficacité.
    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
    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.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    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)
    Included patients are follow up in the next 12 months in a cohort study to evaluate the safety on greater period
    Les patients inclus seront suivis pendant 12 mois après la fin de l'essai afin d'évaluer la tolérance et l'efficacité de la thérapie cellulaire
    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 Decision2022-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-19
    P. End of Trial
    P.End of Trial StatusOngoing
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