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    Summary
    EudraCT Number:2015-000399-81
    Sponsor's Protocol Code Number:APZ2-II-01
    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:2015-09-11
    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 number2015-000399-81
    A.3Full title of the trial
    AN INTERVENTIONAL, SINGLE ARM, PHASE I/IIA CLINICAL TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF APZ2 ON WOUND HEALING OF CHRONIC VENOUS ULCER (CVU)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to investigate in patients with non healing wounds originating from ulcers below the knee how efficacious and safe the investigated medicinal product named APZ2 is in terms of wound healing.
    A.3.2Name or abbreviated title of the trial where available
    ABCB5+ cells for wound healing
    A.4.1Sponsor's protocol code numberAPZ2-II-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 SponsorRHEACELL GmbH & Co. KG
    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 supportRHEACELL GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRHEACELL GmbH & Co. KG
    B.5.2Functional name of contact pointInformation Office
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 517
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number496221718330
    B.5.5Fax number4962217183329
    B.5.6E-mailoffice@rheacell.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 nameAPZ2
    D.3.2Product code APZ2
    D.3.4Pharmaceutical form Cutaneous suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameAPZ1
    D.3.9.4EV Substance CodeSUB177315
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 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
    Chronic venous ulcers (CVU)
    E.1.1.1Medical condition in easily understood language
    The root of venous ulcers is increased pressure of blood in the vessels (veins) of the lower leg causing swelling and damage to the skin leading eventually to a painful non healing wound called ulcer.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066677
    E.1.2Term Chronic leg ulcer
    E.1.2System Organ Class 100000018244
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy and safety evaluation of one dose of the IMP topically administered on wounds of patients with CVU.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 18 to 85 years;
    2. Chronic venous leg ulcer (as defined by the current AWMF guidelines: therapy resistant ulcer that shows no improvement within 3 months despite of optimal phlebological therapies or is not healed within 12 months) for at least 6 weeks but shorter than 3 years diagnosed by doppler ultrasonography (DUS), ankle brachial index (ABI, 0.9–1.3), physical examination and dermatological review;
    3. Wound size between 5 and 50 cm2 measured by a standardized photography at the screening visit;
    4. Wound location between knee and ankle;
    5. Patients suffering from 2 or more ulcers at the same extremity, as long as these ulcers are separated by a minimum bridge of 1 cm of epithelialized skin;
    6. Patients must agree to have at least one biopsy performed before treatment. In case IMP production from the first biopsy is not successful, a second biopsy will be taken;
    7. Body mass index (BMI) between 20 and 40 kg/m²;
    8. Patients understand the nature of the procedure and are providing written informed consent prior to any clinical trial procedure;
    9. Women of childbearing potential must have a negative blood pregnancy test at Screening and at Visit 5 before the IMP application;
    10. Women of childbearing potential and their partner must be willing to use highly effective contraceptive methods during the course of the clinical trial.
    E.4Principal exclusion criteria
    General exclusion criteria
    1. Evidence of the ulcer extending to the underlying muscle, tendon, or bone;
    2. Current long-term use (more than 14 days) of steroid medication above Cushing-threshold dose (>7.5 mg/d prednisone or equivalent);
    3. Diabetes mellitus that has to be evaluated by blood test (Hemoglobin A1c [HbA1c] > 7,5 %);
    4. Peripheral Artery Disease (PAD) including claudication with need of treatment;
    5. Acute deep vein thrombosis (maximum 30 days from diagnosis) or a still untreated deep vein thrombosis;
    6. Unable to tolerate leg ulcer compression bandage;
    7. Infection of the target ulcer requiring treatment as judged clinically;
    8.Wound size <1.5 cm² measured by a standardized photography at Visit 5;
    9. Any chronic dermatological disorders diagnosed at the investigator’s discretion;
    10. Skin disorders, unrelated to the ulcer, that are present adjacent to the target wound;
    11. Current use of medications that influence wound healing: systemic
    immunosuppressives, cytotoxic medicinal products, and systemic steroids (above Cushing-threshold level);
    12. Known abuse of alcohol, drugs, or medicinal products;
    13. Cancerous or pre-cancerous lesions adjacent to the target wound;
    14. Patients anticipated to be unwilling or unable to comply with the requirements of the protocol;
    15. Pregnant or lactating women;
    16. Systemic infectious disease diagnosed by serology testing for syphilis (acute), human immunodeficiency virus (HIVĖ—1, HIV-2), hepatitis B (acute) or C infection at Screening or at Visit 2;
    17. Any known allergies to components of the IMP;
    18. Prior surgical procedures such as bypass or mesh-graft treatment within 2 months prior to IMP application;
    19. Treatment of target ulcer with active wound care agents (e.g. Iruxol, local antibiotics or silver dressings), which have not been paused 14 days before IMP application;
    20. Current or previous (within 30 days of enrollment) treatment with another IMP, or participation and/or under follow-up in another clinical trial;
    21. Previous participation in this clinical trial;
    22. Evidence of any other medical conditions (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the patient’s compliance, or place the patient at high risk of complications related to the treatment;
    23. Employees of the sponsor, or employees or relatives of the investigator.
    Exclusion criteria for efficacy assessments
    1. A wound size enlargement of more than 25% between the wound assessment at the screening visit and the wound assessment at Visit 5;
    2. A wound size reduction of more than 50% between the wound assessment at the screening visit and wound assessment at Visit 5.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of wound size reduction
    2. Assessment of AE occurrence
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 12 post baseline, or last available post-baseline measurement if the Week 12 measurement is missing
    2. During all patient visits except screening
    E.5.2Secondary end point(s)
    1. Percentage of wound size reduction
    2. Absolute wound size reduction
    3. Proportion of patients achieving complete wound closure
    4. Time to first complete wound closure
    5. Proportion of patients achieving 30% wound closure
    6. Time to first 30% wound closure
    7. Epithelialization
    8. Formulation of granulation tissue and wound exudation
    9. Pain assessment as per numerical rating scale (NRS)
    10. Quality of life (QoL) assessment using the SF-36 questionnaire
    11. Dermatologic quality of life assessment using the DLQI questionnaire
    12. Physical examination and vital parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Weeks 2, 3, 4, 6, 8, 10 and 12 post baseline.
    2. Weeks 2, 3, 4, 6, 8, 10, and 12 post baseline.
    3. Weeks 2, 3, 4, 6, 8, 10, and 12 post baseline and at any time point up to week 12.
    4. A priori specification not possible; between baseline and week 12 post baseline
    5. Weeks 2, 3, 4, 6, 8, 10, 12 post baseline.
    6. A priori specification not possible; between baseline and week 12 post baseline
    7. Weeks 2, 3, 4, 6, 8, 10, 12 post baseline.
    8. At baseline and days 3, 8 and weeks 2, 3, 4, 6, 8, 10, 12 post baseline.
    9. At baseline and days 3, 8 and weeks 2, 3, 4, 6, 8, 10, 12 post baseline.
    10. At baseline and weeks 4, 8, 12 post baseline.
    11. At baseline and weeks 4, 8, 12 post baseline.
    12. At Screening, baseline, week 12, month 12.
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety and efficacy in patients
    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 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 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 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
    LVLS
    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 months4
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state37
    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)
    Patients with more then one CVU wound may obtain IMP treatment of the other wounds as well if during the clinical trial the wound healing progress in the IMP treated wound seems to be quicker than in the other wounds (as judged at Visit 15) and the safety profile of the IMP is acceptable as judged by the investigator.
    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 Decision2016-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-17
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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