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    Summary
    EudraCT Number:2019-001361-33
    Sponsor's Protocol Code Number:CYP-CLI-P2-01
    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:2019-12-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-001361-33
    A.3Full title of the trial
    A Randomised, Double-blind, Placebo-controlled Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of CYP-002 in Adults with Critical Limb Ischaemia who are Unsuitable for Revascularisation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the effect CYP-002 in adults with Critical Limb Ischemia who are unsuitable for surgery to improve blood circulation
    A.4.1Sponsor's protocol code numberCYP-CLI-P2-01
    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 SponsorCynata Therapeutics Limited
    B.1.3.4CountryAustralia
    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 supportCynata Therapeutics Limited
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCynata Therapeutics Limited
    B.5.2Functional name of contact pointKilian Kelly
    B.5.3 Address:
    B.5.3.1Street AddressLevel 3, 62 Lygon Street,
    B.5.3.2Town/ cityCarlton, Victoria,
    B.5.3.3Post code3053
    B.5.3.4CountryAustralia
    B.5.4Telephone number +61 39824 5254
    B.5.5Fax number +61 39822 7735
    B.5.6E-mailkilian.kelly@cynata.com
    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 nameMCA-derived MSCs
    D.3.2Product code CYP-002
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNo INN has been allocated
    D.3.9.2Current sponsor codeCYP-002
    D.3.9.3Other descriptive nameALLOGENEIC MESENCHYMAL PRECURSOR CELLS
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100000000
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Critical Limb Ischaemia
    E.1.1.1Medical condition in easily understood language
    Severe blockage in the arteries of the lower extremities
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10058069
    E.1.2Term Critical limb ischemia
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10058072
    E.1.2Term Critical limb ischaemia
    E.1.2System Organ Class 100000004866
    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 efficacy of CYP-002 in adults with CLI, based on improvement in Rutherford Classification up to 12 months after treatment.
    - To assess the safety and tolerability of CYP-002 in adults with CLI, up to 12 months after treatment.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of CYP-002 in adults with CLI, based on different outcome measures at various timepoints up to 24 months after treatment.
    - To further assess the safety and tolerability of CYP-002 in adults with CLI up to 24 months after treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Prospective participants must meet all of the following inclusion criteria to be eligible to participate in the study:
    1. Provide written informed consent.
    2. Male or female, 45 years of age or older.
    3. Diagnosed with CLI, Rutherford Category 5.
    4. At least one of the following findings in the index leg:
    a. ABI of less than 0.5.
    b. Ankle pressure of less than 60 mmHg.
    c. A measurable toe pressure of less than 40 mmHg.
    d. In cases where the ABI is more than 1.4 (indicating false elevation of ABI) and toe pressure is not measurable, inclusion may be based on a TcPO2 reading of less than 30 mmHg.
    5. In the opinion of the Investigator revascularisation is not appropriate or has previously failed.
    6. Negative urine pregnancy test at screening, if applicable (i.e. for female participants of childbearing potential).
    7. Willing to comply with birth control measures (if applicable), to prevent female participants becoming pregnant for six months following administration of the study treatment.
    E.4Principal exclusion criteria
    If prospective participants meet any of the following exclusion criteria, they are ineligible to participate in the study:
    1. Pregnant or breastfeeding
    2. Planning to become pregnant within six months.
    3. Arterial insufficiency in the lower limbs known or suspected to be the result of acute limb ischaemia or an immunological, inflammatory or non-atherosclerotic disorder (e.g. Buerger's Disease, systemic sclerosis).
    4. Undergone surgical or endovascular revascularisation of the index leg within 7 days prior to the planned administration of study treatment.
    5. Amputation at or above the talus of the index leg.
    6. Amputation of the index leg is already planned.
    7. BMI > 45 kg/m2.
    8. Systolic blood pressure ≥180 mmHg.
    9. Received the SGLT2 inhibitor canagliflozin within 60 days prior to the planned administration of study treatment.
    10. Received chemotherapy treatment within 12 months prior to the planned administration of study treatment.
    11. Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned administration of study treatment.
    12. Require improvement of arterial inflow above the aortic bifurcation.
    13. Experienced acute myocardial infarction, unstable angina or stroke within three months prior to screening.
    14. Positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus, Hepatitis C virus or any other infection which the opinion of the Investigator is likely to impact on the ability of the patient to participate in the study.
    15. Active malignancy or history of malignancy within five years prior to screening (with the exception of a past history of basal or squamous cell carcinomas).
    16. Known or suspected (in the opinion of the Investigator) alcohol or substance abuse problem.
    17. Known sensitivity to dimethylsulfoxide (DMSO) or any other component of the study treatments.
    18. Life expectancy of less than six months, in the opinion of the Investigator.
    19. Any other medical or psychiatric condition which, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    - Improvement in Rutherford Classification from Category 5 to Category 4 or lower, from baseline to 12 months

    • Incidence and severity of TEAEs
    • Safety laboratory evaluations (biochemistry, haematology, urinalysis)
    • Vital sign values
    • Oxygen saturation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 12 months after treatment
    E.5.2Secondary end point(s)
    - The efficacy of CYP-002 in adults with CLI will be based on the following outcomes measures over time in the index leg:
    • Improvement in Rutherford Classification from Category 5 to Category 4, or lower*
    • AFS+
    • Change in ABI+
    • Change in ischaemic rest pain as measured by VAS+
    • Extent of wound healing+
    • Change in quality of life as measured by VQ-6+.
    (* Assessed at 6, 18 and 24 months after treatment)
    (+ Assessed at 6, 12, 18 and 24 months after treatment)

    • Incidence and severity of TEAEs
    • Safety laboratory evaluations (clinical chemistry, haematology, urinalysis)
    • Vital signs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 24 months after treatment
    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 Yes
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 81
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 90
    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)
    CYP-002 will not be made available to participants after either the study ends or their participation in the study ends. The care participants receive after the study has ended may involve a different drug or treatment, which the hospital, together with the study doctor, considers to be the most suitable alternative.
    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 Decision2020-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-27
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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