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    Summary
    EudraCT Number:2005-000968-33
    Sponsor's Protocol Code Number:1122334455
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-03-16
    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 ConcernedGermany - PEI
    A.2EudraCT number2005-000968-33
    A.3Full title of the trial
    Doppel-blinde, randomisierte, kontrollierte Studie zur intraarteriellen Transplantation von Knochenmarks-Progenitorzellen bei Patienten mit chronischer Ischämie bei pAVK


    (Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients with Peripheral Arterial occlusive Disease)
    A.3.2Name or abbreviated title of the trial where available
    PROVASA
    A.4.1Sponsor's protocol code number1122334455
    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 SponsorMedizinische Klinik III, Kardiologie, Universität Frankfurt
    B.1.3.4CountryGermany
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraarterial 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Patienten mit angiographisch dokumentierter pAVK Stadium IIb (<50 m Gehstrecke auf dem Laufband, 12% Steigung, 3,2 km/h) mit Auftreten von Claudicatio typischen Beschwerden trotz erfolgter Bewegungstherapie oder Ruheschmerzen (Stadium 3) bzw. periphere Nekrosen oder Ulcera (Stadium IV), die nicht Kandidaten für eine interventionelle oder operative Therapie sind oder keine Besserung bzw. einen Progress der Erkrankung trotz erfolgter Intervention erfahren.
    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
    Im Rahmen der geplanten Studie soll untersucht werden, ob aus dem Knochenmark isolierte und in die distale Arteria femoralis superficialis reinfundierte Progenitorzellen die periphere Durchblutung bei Patienten mit pAVK Stadium IIb-IV signifikant verbessern können.
    E.2.2Secondary objectives of the trial
    Folgende Parameter werden beobachtet:
    Schmerzfreiheit ohne Analgetika oder Reduktion der Ruheschmerzen auf einer definierte Scala (1-10) mit Reduktion der Analgetika

    Verbesserung der schmerzfreien Gehstrecke

    Verbesserungen des Gewebssauerstoffpartialdrucks (TcO2)

    Komplette Abheilung von Ulcera (Zeit bis zur Abheilung von Ulcera, prozentuale Reduktion der Größe der Ulcera)

    Gewebsperfusion und Kollateralendichte (MR-Angio, DSA)

    Einfluss auf ischämische Neuropathie (Sensory und Motor Nerve CV; Neurologische Skalen)

    Notwendigkeit einer Hospitalisation
    Notwendigkeit einer Amputation
    MACE (Tod, Infarkt, Stroke, Atheroembolie)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patienten mit angiographisch dokumentierter pAVK Stadium IIb (<50 m Gehstrecke auf dem Laufband, 12% Steigung, 3,2 km/h) mit Auftreten von Claudicatio typischen Beschwerden trotz erfolgter Bewegungstherapie oder Ruheschmerzen (Stadium 3) bzw. periphere Nekrosen oder Ulcera (Stadium IV), die nicht Kandidaten für eine interventionelle oder operative Therapie sind oder keine Besserung bzw. einen Progress der Erkrankung trotz erfolgter Intervention erfahren.

    Bevorzugt werden Verschlüsse unterhalb des P1-Segmentes der Arteria poplitea (pAVK vom Unterschenkeltyp)

    Patienten mit Morbus Winiwarter Buerger

    Alter 18 – 80 Jahre

    Schriftliche Einverständniserklärung
    E.4Principal exclusion criteria
    Bei Patienten mit pAVK Stadium 3 und 4: Notwendigkeit der interventionellen oder operativen Revaskularisierung innerhalb der letzten 3 Monate.

    Bei Patienten mit pAVK Stadium IIb: Intervention (PTA) innerhalb der letzten 3 Monate

    Isolierte kurzstreckige Stenosen der Unterschenkelarterien, die mittels Stent behandelt werden können.

    Prostavasintherapie innerhalb der letzten 3 Monate

    Aktive Infektion oder Fieber

    Chronisch inflammatorische Erkrankungen (z.B M. Crohn, Rheumatoide Arthritis)

    HIV Infektion oder aktive Hepatitis

    Neoplastische Erkrankungen ohne dokumentierte komplette Remission in den letzten 5 Jahren

    Apoplektischer Insult oder akuter Myokardinfarkt innerhalb von 3 Monaten

    Eingeschränkte Nierenfunktion (Kreatinin > 2 mg/dl) zum Zeitpunkt der Behandlung

    Relevante Lebererkrankung (GOT > 2x des oberen Normwertes oder spontane INR > 1,5).

    Anämie (Hämoglobin < 10 mg/dl)

    Thrombozytenzahl <100.000/µl

    Bekannte Allergien oder Unverträglichkeiten auf Aspirin, Clopidogrel, Heparin

    Anamnese erhöhter Blutungsneigung

    Gastrointestinale Blutung in den letzten 3 Monaten

    Chirurgischer Eingriff oder Trauma in den letzten 2 Monaten

    Schwangerschaft

    Mentale Retardierung

    Teilnahme an einer anderen klinischen Studie in den letzten 30 Tagen
    E.5 End points
    E.5.1Primary end point(s)
    Verbesserung der peripheren Durchblutung gemessen anhand der Verbesserung des Knöchel-Arm Indexes (ABI) oder des Zehen/Arm Indexes (TBI) innerhalb von 3 Monaten nach Zelltherapie
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Studiendauer für jeden Patienten beträgt 6 Monate.
    Die Patienten werden auch nach Ablauf der Studiendauer ambulant betreut.
    Im Falle einer Verbesserung der peripheren Durchblutung nach Stammzelltherapie, koennen Patienten optional in ein Nachfolgeprotokoll zu weiteren Therapien eingeschlossen werden.
    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 months6
    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 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 No
    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 Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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 Decision2005-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-31
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