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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43935   clinical trials with a EudraCT protocol, of which   7309   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2010-024162-22
    Sponsor's Protocol Code Number:ACTLP001-01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-01-24
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2010-024162-22
    A.3Full title of the trial
    A Prospective Open-Label Study to Evaluate the Safety of Cell Bandage (Mesenchymal Stem Cells) in the Treatment of Meniscal Tears
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test the safety of Cell Bandage, a product made from the patient's own bone marrow stem cells, in the treatment of meniscus ("cartilage") tears in the knee
    A.3.2Name or abbreviated title of the trial where available
    Cell Bandage Phase I Safety Study
    A.4.1Sponsor's protocol code numberACTLP001-01
    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 SponsorAzellon Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportAzellon Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzellon Ltd
    B.5.2Functional name of contact pointChief Operating Officer
    B.5.3 Address:
    B.5.3.1Street Address24 Cornhill
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC3V 3ND
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441982551227
    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 name Cell Bandage
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracartilaginous 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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Yes
    D. ATIMP (i.e. one involving a medical device) Yes
    D. 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
    Meniscal tear that would otherwise be treated by a partial meniscectomy.
    E.1.1.1Medical condition in easily understood language
    A tear in the meniscus ("cartilage") in the knee that would otherwise be treated by surgery
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    To evaluate the safety of the Cell Bandage when implanted into lesions in the white (avascular) region of the meniscus.
    E.2.2Secondary objectives of the trial
    To perform observations relating to the efficacy of the implant, for the purpose of providing proof-of-concept of Cell Bandage.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.The subject (or guardian, if appropriate) has signed and dated a specific informed consent form.
    2. The subject agrees to provide a blood sample for testing of HIV-1, HIV-2, hepatitis B, hepatitis C, and syphilis.
    3. The subject is between 18 and 35 years of age, inclusive.
    4. The subject is able to comply with the protocol-defined preoperative procedures, the postoperative clinical and radiographic evaluations and the recommended rehabilitation regimen as determined by the investigator.
    5. The subject has a diagnosis of a MRI confirmed (not older than 6 months), irreparable medial meniscus cartilage tear requiring surgical treatment
    6. The meniscal tear should be a vertical tear in the red/white zone of the meniscus affecting the posterior horn or mid portion of the meniscus
    7. The subject has no anterior cruciate ligament (ACL) deficiency in the involved knee.
    8. Haemoglobin >9g/dL and platelet count >100,000/mm3 prior to Day 1
    9. No contraindication to general anaesthetic
    10. Female subjects of child-bearing potential: a negative urine pregnancy test
    E.4Principal exclusion criteria
    1. The subject has a history of total or partial medial or lateral menisectomy in the involved knee.
    2. The subject has concomitant posterior cruciate ligament insufficiency of the involved knee or a concomitant injury that interferes with the subject’s ability to comply with the recommended rehabilitation program.
    3. The subject has an ACL deficiency or previous ACL surgery.
    4. The subject has a diagnosis of untreatable Grade IV (Outerbridge Classification) degenerative cartilage disease in the involved knee joint.
    5. The subject has an uncorrected malformation or axial malalignment in the involved knee.
    6. Patients demonstrating an active local or systemic infection (WBC > 15,000/mm3)
    7. Any condition which in the judgment of the Investigator would preclude adequate evaluation of the CB and clinical outcome.
    8. The subject has a history of anaphylactoid reaction.
    9. The subject has an active systemic or local infection.
    10. The subject has been tested positive for any of the following diseases: HIV (anti-HIV-1 or anti-HIV-2), Hepatitis B (HBs-Ag and anti-Hbc) and Hepatitis C (HCV-Ab), or syphilis (treponema pallidum; not RPR).
    11. The patient does not wish to know the results of the screening HIV-1, HIV-2, hepatitis B, hepatitis C or syphilis blood tests
    12. The subject has received systemic administration of any type of corticosteroid, antineoplastic, immunostimulating, or immuno-suppressive agents within 30 days prior to the scheduled bone marrow absorption or surgery.
    13. The subject has evidence of osteonecrosis of the involved knee.
    14. The subject has a medical history that includes a confirmed diagnosis of rheumatoid or inflammatory arthritis, or relapsing polychondritis.
    15. If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months
    E.5 End points
    E.5.1Primary end point(s)
    Preliminary safety data will be gathered with respect to the number, timing, severity, duration and resolution of related and non-related adverse events occurring among study subjects This includes incidence and severity of surgical complications such as the common known surgical complications associated with this type of surgical procedures; such as: chronic pain, arthrofibrosis, damage to the neurovasculature, osteonecrosis, postsurgical inflammation, infection, bleeding, and deep vein thrombosis. Other adverse events and significant changes in clinical parameters from baseline

    Clinical Outcome:
    Percentage of patients that have partial or full menisectomy during or after the initial procedure within the study follow-up period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoint data will be obtained at the following timepoints:
    1 week, 1, 3, 6 & 12 months, 2, 3, 4, 5, 6, 7 years
    E.5.2Secondary end point(s)
    Post-operative MRI compared to pre-implantation
    Pain compared to baseline
    Range of motion of the knee
    Pain medication
    E.5.2.1Timepoint(s) of evaluation of this end point
    Post-operative MRI compared to pre-implantation - 3 & 6 months, 2 years post-implantation
    Pain compared to baseline - 3 & 6 months
    Range of motion of the knee - 3, 6 & 12 months, 2, 3, 4, 5, 6, 7 years
    Pain medication - 1, 3, 6 & 12 months, 2, 3, 4, 5, 6, 7 years
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    Last visit of the last subject undergoing the trial
    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 years0
    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 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: 10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 10
    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)
    Data will be collected at yearly intervals to a maximum of 7 years follow-up (main trial 2 years plus a 5 year follow-up phase), including the following: Tegner Index, Lysholm Score, IKDC, and VAS pain scale, which will be used throughout the post-clinical follow-up surveillance. Subjects will already be familiar with these metrics since they are the same as those collected on self-assessment forms used for the clinical evaluation visits after surgery
    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 Decision2011-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-02
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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