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    Summary
    EudraCT Number:2015-001820-51
    Sponsor's Protocol Code Number:BMC2012-PhaseII
    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:2015-10-15
    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 number2015-001820-51
    A.3Full title of the trial
    BMC2012, Cell based therapy by implanted bone marrow-derived mononuclear cells (BMC) for bone augmentation of plate-stabilized proximal humeral fractures - a randomized, open, multicentric study - phase IIa
    BMC2012, Zellbasierte Therapie mit bone marrow-derived mononuclear cells (BMC) zur Knochenaugmentation bei der Osteosynthese proximaler Humerusfrakturen - eine randomisierte, offene, multizentrische Phase IIa Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BMC2012, Cell based therapy by implanted bone marrow-derived mononuclear cells (BMC) for bone augmentation of plate-stabilized proximal humeral fractures - a randomized, open, multicentric study - phase IIa
    BMC2012, Zellbasierte Therapie mit bone marrow-derived mononuclear cells (BMC) zur Knochenaugmentation bei der Osteosynthese proximaler Humerusfrakturen - eine randomisierte, offene, multizentrische Phase IIa Studie
    A.3.2Name or abbreviated title of the trial where available
    Cell based therapy by implanted BMC for bone augmentation of humeral fractures, Phase IIa
    Zellbasierte Therapie mit BMC zur Knochenaugmentation bei Knochendefekten, Phase IIa
    A.4.1Sponsor's protocol code numberBMC2012-PhaseII
    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 SponsorDekan der medizinischen Fakultät, Universitätsklinikum Frankfurt, Goethe-Universität
    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 supportHessisches Ministerium für Wissenschaft und Kunst
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Frankfurt, Goethe-Universität
    B.5.2Functional name of contact pointProf. Dr. Ingo Marzi
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60590
    B.5.3.4CountryGermany
    B.5.4Telephone number+496963016123
    B.5.5Fax number+496963016439
    B.5.6E-mailmarzi@trauma.uni-frankfurt.de
    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 nameBone marrow-derived mononuclear cells (BMC)
    D.3.4Pharmaceutical form Implantation suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraosseous use
    Implantation
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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 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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Investigation of cell based therapy by implanted bone marrow-derived mononuclear cells for bone augmentation on osteosynthesis of proximal humeral fractures
    Untersuchung der zellbasierten Therapie von bone marrow-derived mononuclear cells zur Knochenaugmentation bei der Osteosynthese proximaler Humerusfrakturen
    E.1.1.1Medical condition in easily understood language
    Subcapatical humeral fractures
    Subkapitale Humerusfrakturen
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    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
    Osseous healing of fracture after 12 weeks by radiological evaluation:
    • Frequency of secondary dislocation of result of reposition (varus dislocation of ≥ 20° of head/shaft angle α, Δα)
    Beurteilung der knöchernen Frakturheilung nach 12 Wochen durch die radiologische Evaluation:
    • Häufigkeit der sekundären Dislokation des Repositionsergebnisses (Varus-Dislokation von ≥ 20° des Kopf-Schaft-Winkels α, Δα)
    E.2.2Secondary objectives of the trial
    a) Osseous healing of fracture
    • osseous healing of fracture (consolidation, necrosis)
    • secondary perforation of bone screw
    • quantitative evaluation of Δα
    b) With regards to tolerability / side effects:
    • Morbidity extraction
    • local infection / side effects (inflammation, wound healing disorder),
    • systemic infection / side effects (BB, CRP, IL-6, PCT),
    • Fever (>38,5°C) longer than 2 days
    c) Shoulder function: DASH-Score (12 weeks post-op)
    d) Registration of concomitant medication (visits 1-5) and adverse
    events (visits 2-5)
    a) Frakturheilung
    • Frakturheilung (Konsolidierung, Nekrose)
    • sekundäre Perforation von Schrauben
    • quantitative Auswertung von Δα
    b) Speziell für die Verträglichkeit wird überprüft:
    • die Morbiditätsentnahme,
    • lokale Infektion/Nebenwirkung (Entzündung, Wundheilungsstörung),
    • systemische Infektion/Nebenwirkung (BB, CRP, IL-6, PCT),
    • Fieber (>38,5°C) länger als 2 Tage.
    c) Funktion der Schulter: DASH-Score (12 Wochen postoperativ)
    d) Erfassung der Begleitmedikation (V1-5) und AEs (V2-5)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients aged from ≥50 to ≤90 with proximal humeral fracture
    • Indication for open reposition and internal stabilization using a proximal fixed-angle plate for humerus (PHILOS®, Synthes, Oberdorf, Schweiz)
    • 2-, 3- or 4-fragment fracture according to Neer
    • Dislocation of ≥10 mm between fragments and/or
    • Angle of ≥45° between fragments and/or
    • Dislocation of tuberkulum majus of ≥5 mm
    • negative pregnancy test of premänopausal women
    • Ability to understand the content, consequence and improtance of the clinical trial
    • Signed informed consent form for surgery and participation in the clinical trial
    • Patienten zwischen dem ≥50. und ≤90. Lebensjahr mit einer proximalen Humerusfraktur
    • Indikation für eine offene Reposition und interne Stabilisierung mit einer proximalen winkelstabilen Platte für den Humerus (PHILOS®, Synthes, Oberdorf, Schweiz)
    • 2-, 3- oder 4-Fragment Fraktur nach Neer
    • Dislokation von ≥10 mm zwischen den Fragmenten und/oder
    • Winkel von ≥45° zwischen den Fragmenten und/oder
    • Dislokation des Tuberkulum majus von ≥5 mm
    • negativer Schwangerschaftstest bei prämenopausalen Frauen
    • Fähigkeit, das Wesen, die Tragweite und Bedeutung der klinischen Prüfung zu verstehen
    • Unterschriebene Einverständniserklärung für die Operation und die Studienteilnahme
    E.4Principal exclusion criteria
    • Contraindications against administration of IMP are pregnancy and breast-feeding
    • Dislocation fracture
    • Known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression)
    • Patients not qualified for legal acts
    • Pathologic fractures caused by underlying diseases
    • Fracture-induced nerve damage
    • Tumor diseases with recent adjuvant therapy or treatment during the last 3 months (e.g. chemotherapy, radiotherapy), untreated tumor diseases
    • Participation in a clinical trial during the last 3 months prior inclusion to this study
    • Kontraindikationen gegen die Gabe des Prüfpräparats sind Schwangerschaft und Stillzeit
    • Luxationsfraktur
    • bekannte psychische Erkrankung, wodurch die Kooperation deutlich erschwert ist (z.B. Demenz, Schizophrenie, schwere Depression)
    • nicht geschäftsfähige Patienten
    • pathologische Frakturen verursacht durch andere Grunderkrankungen
    • Fraktur-bedingter Nervenschaden
    • Tumorerkrankung mit adjuvanter Therapie oder Behandlung innerhalb der letzten 3 Monate (z.B. Chemotherapie, Strahlentherapie), unbehandelte Tumorerkrankungen
    • Teilnahme an klinischer Studie innerhalb der letzten 3 Monate vor Einschluss in diese Studie
    E.5 End points
    E.5.1Primary end point(s)
    a)Osseous healing of fracture after 12 weeks by radiological evaluation:
    • Frequency of secondary dislocation of result of reposition (varus dislocation of ≥ 20° of head/shaft angle α, ∆α)
    a) Knöcherne Heilung der Fraktur:
    • Häufigkeit der sekundären Dislokation des Repositionsergebnisses (Varus-Dislokation von ≥ 20° des Kopf-Schaft-Winkels α, ∆α)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks post-op
    12 Wochen postoperativ
    E.5.2Secondary end point(s)
    Secondary end points are:
    a) Osseous healing of fracture
    • osseous healing of fracture (consolidation, necrosis)
    • secondary perforation of bone screw
    • quantitative evaluation of ∆α
    b) With regards to tolerability / side effects:
    • Morbidity extraction
    • local infection / side effects (inflammation, wound healing disorder),
    • systemic infection / side effects (BB, CRP, IL-6, PCT),
    • Fever (>38,5°C) longer than 2 days
    c) Shoulder function: DASH-Score (12 weeks post-op)
    d) Registration of concomitant medication (visits 1-5) and adverse events (visits 2-5)
    Die sekundären Zielkriterien sind:
    a) Frakturheilung
    • Frakturheilung (Konsolidierung, Nekrose)
    • sekundäre Perforation von Schrauben
    • quantitative Auswertung von Δα
    b) Speziell für die Verträglichkeit wird überprüft:
    • die Morbiditätsentnahme,
    • lokale Infektion/Nebenwirkung (Entzündung, Wundheilungsstörung),
    • systemische Infektion/Nebenwirkung (BB, CRP, IL-6, PCT),
    • Fieber (>38,5°C) länger als 2 Tage.
    c) Funktion der Schulter: DASH-Score (12 Wochen postoperativ)
    d) Erfassung der Begleitmedikation (V1-5) und AEs (V2-5).
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) visits 1 to 5
    b) visit 5, 12 weeks post-op
    c) concomitant medication (visits 1-5) and adverse events (visits 2-5)
    a) Visite 1 bis 5
    b) Visite 5, 12 Wochen postoperativ
    c) Begleitmedikation (V1-5) und AEs (V2-5)
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability (side effects)
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Die Patienten der Kontrollgruppe erhalten das zellfreie Knochenersatzmaterial beta-TCP
    Patients of control group will receive cell-free bone substitute beta-TCP
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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 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
    closure of last trial site
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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: 47
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 47
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state94
    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)
    None
    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 Decision2016-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-07
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