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    The EU Clinical Trials Register currently displays   42517   clinical trials with a EudraCT protocol, of which   7000   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-001187-21
    Sponsor's Protocol Code Number:SCRM-001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2011-05-30
    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 number2011-001187-21
    A.3Full title of the trial
    A Phase I/II, Open Monocentric Study To Evaluate The Safety And Efficacy Of An Autologous Tissue-Engineered Vascular Graft In Peadiatric Patients Requiring Reconstruction Of Right Ventricle Outflow Tract.
    Offene, monozentrische Phase-I/II Pilot-Studie zur Untersuchung der Wirksamkeit eines aus körpereigenen Zellen hergestellten, Blutgefässkonstrukts bei Kindern die eine Rekonstruktion des rechtsventrikulären Ausflusstrakts benötigen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study with children suffering from congenital heart defect who need a vascular surgery: Implantation of a living blood vessel that is produced in the laboratory from child's own body tissue.
    Pilotstudie am Herzzentrum Leipzig bei Kindern mit einem angeborenen
    Herzfehler, die eine Gefässoperation benötigen:
    Einsetzen eines lebenden, körpereigenen, im Labor hergestellten Blutgefässes.
    A.3.2Name or abbreviated title of the trial where available
    SCRM-001 TEVG Study
    A.4.1Sponsor's protocol code numberSCRM-001
    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 SponsorUniversity of Zurich
    B.1.3.4CountrySwitzerland
    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 supportXeltis AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitiy of Zurich
    B.5.2Functional name of contact pointZentrum für Regenerative Medizin
    B.5.3 Address:
    B.5.3.1Street AddressMoussonstrasse 31
    B.5.3.2Town/ cityZürich
    B.5.3.3Post code8091
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41044634 56 25625
    B.5.5Fax number+41044634 56 20620
    B.5.6E-mailheike.idler@usz.ch
    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 nameAutologous Tissue-Engineered Vascular Graft
    D.3.2Product code SCRM001_TEVG
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    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 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
    functional single ventricle physiology
    functional single left ventricle
    functional single right ventricle
    functional single biventricle
    E.1.1.1Medical condition in easily understood language
    congenital heart defect that requires surgical intervention
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10040729
    E.1.2Term Single ventricle
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the safety of the TEVG as defined by 'number of patients with graft related post-operative complications' requiring surgery or leading to death within the first 6 months after TEVG implantation
    E.2.2Secondary objectives of the trial
    Evaluation of the efficacy of the implated TEVG, analysing the incidence of:
    - Loss of functionality of the TEVG requiring surgery
    - Medical condition related to TEVG requiring surgery withing 6, 12, 24 and 36 months after TEVG implantation

    Evaluation of the long-term safety of the implanted TEVG, as defined by 'number of patients with graft related post-operative complications' within 12, 24 and 36 months after TEVG implantation

    Evaluation of the biological growth in diameter of the TEVG within 12, 24 and 36 months after TEVG implantation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Functional single ventricle physiology (functional single left ventricle,
    functional single right ventricle, functional single biventricle)
    - Male or female
    - Age: 2 - 6 years
    - Parental / legal guardian’s consent on behalf of the minor subject
    E.4Principal exclusion criteria
    - Pulmonary artery pressure (PAP) > 15 mm Hg as excluded by angiography/cardiac catheter
    - Pulmonary vascular resistance (PVR) >3 Wood units as excluded by angiography/cardiac catheter
    - Moderate or severe atrioventricular (AV) valve regurgitation requiring correction, as determined by echocardiography and / or angiography
    - Moderate or severe outflow valve regurgitation requiring correction as
    determined by echocardiography and / or angiography
    - Outflow tract (aortic arch and isthmus) obstruction as excluded by
    a) a residual outflow gradient of ≥ 20mm Hg or
    b) requirement of corrective surgery
    as determined by angiography/cardiac catheter
    - All arrhythmia other than normal sinus rhythm as determined by ECG
    and / or at the investigator’s discretion
    - Renal dysfunction as excluded by serum creatinin > ULN and / or urea
    >ULN and / or at the investigator’s discretion
    - Hepatic dysfunction as excluded by ALT >ULN, AST > ULN, GGT >
    ULN and / or at the investigator’s discretion
    - Coagulation disorders as defined by INR outside its normal value, PTT
    >ULN and Fibrinogen <LLN and / or at the investigator’s discretion
    - Transcutaneous O2 saturation < 65% or at the investigator’s discretion
    - Immunodeficiency (ies) / Immune-syndromes
    - Trisomia 21
    - Asplenia as excluded by abdominal ultrasound
    - Heterotaxia as excluded by abdominal ultrasound
    - HIV-infection
    - Syphillis (Treponema pallidum)
    - Hepatitis-B and /or –C virus infection
    - Unwillingness of Parental / legal guardian’s to give consent
    - Contraindications on ethical grounds
    - Treatment with other investigational products
    - Known or suspected non-compliance, drug or alcohol abuse of the parents / legal guardian
    - Inability of the parents / legal guardians to follow the procedures of the study, e.g. due to language problems
    - Participation of the patient in another study within 30 days preceding
    and during the present study
    - Previous enrollment of the patient into the current study
    - Enrollment of the investigator’s family members, employees and other
    dependent persons
    E.5 End points
    E.5.1Primary end point(s)
    This primary study endpoint is the safety of the TEVG after 6 months of postimplantation.
    This endpoint will be evaluated by the number of patients with graft related postoperative
    complications requiring surgery or leading to death within the first 6 months of post-implantation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 month after TEVG implantation
    E.5.2Secondary end point(s)
    Safety:
    Secondary study endpoints will address the long-term safety of the implanted TEVG,
    as defined by ‘number of patients with graft related post-operative complications’ within the first
    12, 24, 36 months after TEVG implantation by assessing all SAEs / graft related SAEs and cardiovascular related other relevant AEs.

    Evaluation of the efficacy of the implanted TEVG, analysing the incidence of Loss of functionality of the TEVG requiring surgery
    Medical condition related to TEVG requiring surgery within 6, 12, 24 and 36 months after TEVG implantation.

    Evaluation of biological growth:
    Evaluation of the biological growth of the TEVG will be determined by
    echocardiographic measurements of the diameter of the TEVG until 36 months after
    surgery.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 12, 24 and 36 months after TEVG implantation
    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 Yes
    E.6.13.1Other scope of the trial description
    Evaluation of biological growth of implant
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 10
    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.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Study population is 2 to 6 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    A clinical follow-up after the end of the study is to be performed by the investigator or delegated by the investigator to a health care professional. Duration and frequency of clinical follow up shall be determined on a subject-by-subject basis, but at least once a year. A safety and efficacy follow up protocol will be be established and amended as needed in accordance with the evolving experience with the ATIMP.
    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 Decision2011-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-28
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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