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    The EU Clinical Trials Register currently displays   37995   clinical trials with a EudraCT protocol, of which   6234   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-024409-11
    Sponsor's Protocol Code Number:LSC-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-05-27
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-024409-11
    A.3Full title of the trial
    Pilot Clinical Assessment of Ex Vivo Expanded Corneal Limbal Stem Cell Transplantation in Patients with Severe Ocular Surface Disease (OSD) Arising from Limbal Stem Cell Deficiency
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Test a Novel Treatment Using Adult Stem Cells for Transplantation as a Treatment for Eye Disease
    A.4.1Sponsor's protocol code numberLSC-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 SponsorScottish National Blood Transfusion Service
    B.1.3.4CountryUnited Kingdom
    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 supportScottish National Blood Transfusion Service
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScottish National Blood Transfusion Service
    B.5.2Functional name of contact pointRegulatory Compliance Manager
    B.5.3 Address:
    B.5.3.1Street Address21 Ellen's Glen Road
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH17 7QT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004401315365763
    B.5.5Fax number004401315365773
    B.5.6E-mailjacqueline.barry@nhs.net
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    B.1.3.4CountryUnited Kingdom
    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 supportNHS Lothian
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNHS Lothian
    B.5.2Functional name of contact pointDouglas Young
    B.5.3 Address:
    B.5.3.1Street AddressResearch and Development Office, Queen's Medical Research Institute, Little France Crescent
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH16 4TJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004401312423337
    B.5.5Fax number004401312423343
    B.5.6E-maildouglas.young@luht.scot.nhs.uk
    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 nameEx-vivo Corneal Limbal Stem Cell Product
    D.3.4Pharmaceutical form Living tissue equivalent
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameConfluent Allogeneic Limbal Stem Cells
    D.3.10 Strength
    D.3.10.1Concentration unit cm2 square centimeter
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman derived material
    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
    Severe Ocular Surface Disease (OSD)
    E.1.1.1Medical condition in easily understood language
    Eye Disease
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10067103
    E.1.2Term Ocular surface disease
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Determination of feasibility, efficacy and safety of transplantation of ex vivo expanded corneal limbal stem cells


    E.2.2Secondary objectives of the trial
    - Assessment of improvement in vision and quality of the ocular surface
    - Assessment of comparision of immunosuppression and limbal stem cell transplantation with using immunosuppression and amniotic membrane alone
    - To generate the data required for reliable sample size calculations for subsequent studies
    - To evaluate all the practicalities and logistics of the study including the recruitment process, follow-up procedures, data collection and analysis
    - To obtain information on actual recruitment rate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients, of either sex, with bilateral corneal blindness due to limbal stem cell deficiency
    - Visual acuity less than 3/60 in the better eye
    - Severe, debilitating corneal disease with extremely low chance of successful outcome with limbal and corneal graft surgery
    - Functioning retina indicated by light perception and ultra-sonographic examination to exclude retinal detachment
    - Normal intra-ocular pressure
    - Schirmer’s test at least 50% normal values
    E.4Principal exclusion criteria
    - Inability to give informed, comprehending consent
    - Unfitness for local or general anaesthesia
    - Inability to self-administer medication
    - Inability to tolerate immunosuppressive therapy
    - Severe dry eyes
    - Patients with corneal anaesthesia
    - Patients with severe lid deformities
    - Patients with uncontrolled glaucoma or drainage procedures
    E.5 End points
    E.5.1Primary end point(s)
    The best visual acuity will be calculated for each patient from all post treatment observations available
    E.5.1.1Timepoint(s) of evaluation of this end point
    The main analysis will take place when patients have finished all follow-ups. An interim analysis will also take place after all patients have completed 9 months of follow-up.
    E.5.2Secondary end point(s)
    - Ocular surface score – image analysis based evaluation of area of neovascularisation, area of opacity and degree of abnormal fluorescein staining
    - Quality of Life – as assessed by validated questionnaires VF14 and SF36
    - Successful re-establishment of corneal surface after treatment, defined as absence of corneal vascularisation, absence of goblet cells on the cornea surface, absence of persistent epithelial defects, smooth corneal epithelium and no staining with fluorescein, non-fibrotic and normal limbal anatomy
    - Engraftment of donor cells
    E.5.2.1Timepoint(s) of evaluation of this end point
    The main analysis will take place when patients have finished all follow-ups. An interim analysis will also take place after all patients have completed 9 months of follow-up.
    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 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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Amniotic membrane
    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 Information not present in EudraCT
    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
    The end of trial is defined as last visit that the last patient will be seen during the follow up period.

    Following the surgical procedure (implant of clinical product), patients will be seen 1, 3, 7 and 14 days after surgery.
    Following this they will be seen at regular intervals at 1, 3, 6, 9, 12, 15 and 18 months.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 No
    F.1.1Number of subjects for this age range: 0
    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: 20
    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 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 state20
    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)
    Follow-up procedures defined in protocol
    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 Decision2011-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-03-14
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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