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    Summary
    EudraCT Number:2011-003594-28
    Sponsor's Protocol Code Number:BCCT2011
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-11-14
    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 ConcernedGermany - PEI
    A.2EudraCT number2011-003594-28
    A.3Full title of the trial
    A Comparative Observational Prospective Randomized Open-Label Study on Efficacy of BioSeed®-C and chondrotissue® Treatment of Local Femoral Cartilage Defects in the Knee.
    Eine offene vergleichende prospektive randomisierte Anwendungsbeobachtung zur Wirksamkeit von BioSeed®-C und chondrotissue® bei der Behandlung von lokalen femuralen Knorpeldefekten im Knie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparative observational clinical study on efficacy ofBioSeed®-C and chondrotissue® treatment of cartilage defects in the knee joint.
    Eine offene vergleichende Studie zur Wirksamkeit von BioSeed®-C und chondrotissue® bei der Behandlung von Knorpeldefekten im Kniegelenk.
    A.3.2Name or abbreviated title of the trial where available
    Comparison of BioSeed®-C treatment with advanced microfracture treatment
    Vergleich von BioSeed®-C Behandlung mit der weiterentwickelten microfracturiereung
    A.4.1Sponsor's protocol code numberBCCT2011
    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 SponsorBioTissue Technologies 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 supportBioTissue Technologies GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioTissue Technologies GmbH
    B.5.2Functional name of contact pointClinical Study Managment
    B.5.3 Address:
    B.5.3.1Street AddressEngesser Straße 4b
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79108
    B.5.3.4CountryGermany
    B.5.4Telephone number+49(0)767676100
    B.5.5Fax number+49(0)767676430
    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 Yes
    D.2.1.1.1Trade name BioSeed®-C
    D.2.1.1.2Name of the Marketing Authorisation holderBioTissue Technologies GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameBioSeed®-C
    D.3.4Pharmaceutical form Living tissue equivalent
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    Implantation
    Intracartilaginous 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) Yes
    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 Yes
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Yes
    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
    focal femoral cartilage defects in the knee joint
    umschriebene femorale Knorpeldefekte im Kniegelenk
    E.1.1.1Medical condition in easily understood language
    clearly differentiated cartilage defect in the knee joint
    klar abgegrenzter Knorpelschaden im Kniegelenk
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10007705
    E.1.2Term Cartilage damage
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10057104
    E.1.2Term Cartilage repair
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to show that arthroscopic itransplantation of BioSeed®-C leads to an improved outcome after 12 months compared to the advanced microfracture treatment with implantation of chondrotissue® as assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS).
    Hauptziel der Studie ist zu zeigen, dass die arthroskopische Transplantation von BioSeed®-C nach 12 Monaten im Vergleich zur weiterentwickelten Microfracturierung (Mikrofrakturierung mit Implantation von chondrotissue®) zu einem besseren Ergebns im Knee Injury and Osteoarthritis Outcome Score (KOOS) führt.
    E.2.2Secondary objectives of the trial
    The secondary objective is to show that arthroscopic implantation of BioSeed®-C in large defects (4-6cm2) leads to a similar or better outcome after 12 months compared to arthroscopic advanced microfracture treatment with chondrotissue® as assessed by KOOS.
    Additionally, the secondary objective is to show that arthroscopic advanced microfracture treatment with chondrotissue® in small defects (1-4cm2) leads to a similar or better outcome after 12 months compared to arthroscopic implantation of BioSeed®-C as assessed by KOOS.
    Furthermore, tissue regeneration and defect filling will be analysed by MRI pre-operatively and 6, 12, and 24 months after implantation, clinical outcome and pain situation will be further determined by (ICRS, VAS pain, Tegner Score, SF-36, Lysholm) after 0, 6, 12 and 24 months.
    Product safety will be assessed by patient evaluation questionnaire after 12 and 24 months.
    Das Nebenziel der Studie ist zu zeigen, dass die arthroskopische Transplantation von BioSeed®-C in großen Defekten (4-6cm2) nach 12 Monaten zu einem gleichen oder besseren Ergebnis im KOOS gegenüber der weiterentwickelten Microfracturierung führt. Zusätzlich soll gezeigt werden, dass die weiterentwickelte Mikrofrakturierung im Vergleich zur Transplantation von BioSeed®-C nach 12 Monaten zu gleichen oder besseren Ergebnissen im KOOS in kleinen Defekten (1-4cm2) führt. Des Weiteren soll die Defektfüllung und die Geweberegeneration mittels Magnetresonanztomographie (MRT) nach 6,12, und 24 Monaten im Vergleich zur prä-operativen Situation beurteilt werden. Klinischer Erfolg sowie die Schmerzsituation der Patienten wird mittels Patientenfragebögen (ICRS, VAS pain, Tegner Score, SF-36, Lysholm) 0, 6, 12 und 24 Monaten evaluiert. Die Daten zur Produktsicherheit werden mittels eines Patientenfragebogens nach 12 und 24 Monaten evaluiert.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Local femoral defect at the knee joint (Outerbridge class III or IV)
    • Defects at the lateral and medial chondyle
    • Cartilage defect size: (after defect cleaning)
    • Patients male and female between 18 and 50 years of age at the time of surgery
    • Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical evaluations/visits
    • Patients who have signed the Ethics Committee-approved Informed Consent Form prior to surgery
    • Indications for microfracture or ACT respectively
    • focal and contained lesions
    • full-thickness loss of articular cartilage in weight-bearing areas
    • unstable cartilage covering the underlying intact subchondral bone
    • degenerative changes in a knee that is normally aligned
    lokaler femoraler Defekt am Kniegelenk (Outerbridge Klassifikation III oder IV)
    Defekt an der lateralen oder medialen Femurkondyle
    Knorpeldefektgröße 1 – 6 cm2 (nach Defektsäuberung)
    männliche und weibliche Patienten zwischen 18 und 50 Jahren
    Patienten, die die Umstände der Studie verstehen und die Termine/Visiten für die Nachbeobachtung einhalten können
    Patienten, die die von der Ethikkommission genehmigte Einverständniserklärung vor der Operation unterzeichnet haben
    Patienten, die die Indikation für Mikrofrakturierung oder Autologe Chondrozyten Implantation (ACI) zeigen
    Patienten mit fokalen abgegrenzten Läsionen
    Verlust des kompletten Knorpels bis zum Knochen in belasteten Arealen des Knies
    Patienten mit instabilem Knorpel mit intakter subchondralem Knochen
    Degenerative Veränderungen in einem Knie, das eine normale Achse aufweist
    E.4Principal exclusion criteria
    • Known allergic reactions or hypersensitivity to bovine proteins, PGA, fibrinogen, thrombin, heparin or hyaluronan
    • Defect of the femoropatellar joint
    • Varus and valgus (more than 5°) (30 cm one leg standing apical X-ray)
    • General osteoarthritis (two or more compartments)
    • Rheumatoid arthritis or Bechterew’s disease
    • Joint stiffness (flexion less than 90°)
    • Obesity > 32 BMI
    • Laxity
    • Meniscus lesions with more than 1/3 partial resection
    • History with previous cartilage surgery (osteochondral transplantation (OCT), autologous chondrocyte transplantation (ACT))
    • History with previous microfracture in the symptomatic defect less than 6 months
    • History with previous knee surgery (anterior crucial ligament, meniscus refixation, osteotomy) less than 6 months
    • Osteochondral defects
    • Planned pregnancy, pregnancy and breastfeeding
    • Autoimmune-diseases
    bekannte allergische Reaktionen oder hypersensitivitäten gegen Rinderprotein, PGA, Fibrinogen, Thrombin, Heparin oder Hyaluronsäure
    Defekte am femoropatellargelenk
    X und O Beinikeit (mehr als 5°gemessen über 30cm am stehenden Bein am apikal aufgenommenen Röntgenbild)
    Generelle Osteoarthritis (2 oder mehr betroffene Kompartimente)
    Rheumatoide Arthritis oder Motrbus Bechterew
    Gelenksteifikeit (Beugung weniger als 90°)
    Übergewicht BMI>32
    Überdehnbarkeit der Gelenke
    Meniskusläsionen mit mehr als 1/3 partieller Resektion
    Krankengeschichte mit vorausgegangenem chirurgischem Eingriff am Gelenkknorpel (osteochondrale Transplantation (OCT), autologe Chondrozytentransplantation (ACT))
    Krankengeschichte mit vorausgegangener Mikrofrakturierung am symptomatischen Defekt vor weniger als 6 Monaten
    Krankengeschichte mit vorausgegangenem Eingriff am Gelenk (Kreuzband, Meniskusrefixation oder Osteotomie) vor weniger als 6 Monaten
    Osteochondrale Defekte
    Geplante Schwangerschaft, Schangerschaft oder Stillen
    Autoimmunkrankheiten
    E.5 End points
    E.5.1Primary end point(s)
    The active pharmaceutical ingredient (autologous chondrocytes) will persist in the defect after BioSeed®-C transplantation.
    Die aktive Substanz (autologe Chondrozyten) verbleiben nach Transplantation von BioSeed®-C im Defekt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    nicht anwendbar
    E.5.2Secondary end point(s)
    not applicable
    nicht anwendbar
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    nicht anwendbar
    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 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 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
    the medical device "chondrotissue" is CE marked and on the market since 2007
    E.8.2.4Number of treatment arms in the trial4
    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
    End of the trial 24 months (LVLS) post operatively
    Nach 24 Monaten postoperativ (LVLS)
    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 months0
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) No
    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 state80
    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)
    The product BioSeed®-C is made for single use only. The autologous chondrocytes as aktive substance remain in the defect. After the end of the clinical trial patients with symptoms will be treated using standard medical care of the general health care system.
    Das Produkt BioSeed®-C ist für eine einmalige Anwendung konzipiert. Die aktive substanz humane autologe Chondrozyten verbleiben im Defekt. Nach Ende der klinischen Studie werden die Patienten bei Beschwerden im Rahmen der generellen medizinischen Versorgung behandelt, die dem aktuellen Wissensstand entspricht.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
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