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    The EU Clinical Trials Register currently displays   36122   clinical trials with a EudraCT protocol, of which   5938   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-000235-14
    Sponsor's Protocol Code Number:allo-APZ2-PAOD-II-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-20
    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 number2017-000235-14
    A.3Full title of the trial
    A RANDOMISED, PLACEBO-CONTROLLED, DOUBLE-BLIND, INTERVENTIONAL, MULTICENTER, PHASE I/IIA CLINICAL TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF ALLO-APZ2-PAOD FOR THE TREATMENT OF PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (PAOD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to investigate how efficacious and safe the investigated medicinal product named allo-APZ2-PAOD is in terms of wound healing in patients with non healing wounds due to peripheral arterial occlusive disease.
    A.4.1Sponsor's protocol code numberallo-APZ2-PAOD-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 number+496221718330
    B.5.5Fax number+4962217183329
    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 nameallo-APZ2-PAOD
    D.3.2Product code allo-APZ2-PAOD
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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.3.9.2Current sponsor codeT202-3
    D.3.9.3Other descriptive nameAllogeneic skin-derived ABCB5-positive mesenchymal stem cells
    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) 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 in pre-filled syringe
    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
    peripheral arterial occlusive disease
    E.1.1.1Medical condition in easily understood language
    Peripheral arterial occlusive disease is a chronic vascular disease in which the arteries supplying the extremities are narrowing or closing. The lack of blood supply can lead to non-healing wounds.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10062585
    E.1.2Term Peripheral arterial occlusive disease
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of PAOD-related clinically relevant ulcers) and safety (by monitoring adverse events [AEs]) of one dose of allo-APZ2-PAOD administered intramuscularly into an affected lower leg of patients with PAOD.
    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 45 to 85 years;
    2. Patients having PAOD clinically confirmed (maximal systolic ankle pressures ≤ 70 mmHg or systolic toe pressures ≤ 50 mmHg or transcutaneous partial oxygen pressures (tcp02) ≤ 30 mmHg in supine position) as Rutherford category 5 in at least one lower extremity;
    3. Angiography results (DSA, CTA or MRA) for the localization of the high-grade obstruction of an artery of the affected leg (≥ 70 %) that is the leading cause for the ulceration are present and not older than 6 months;
    4. One or more clinically relevant and quantifiable ulcer(s) below the ankle with a minimum size of 0.5 cm² per ulcer and a maximum wound size of 20 cm² for all ulcers together;
    5. Positive vote of the Advisory Board on the suitability of the wound(s) for enrolment, based on the wound photographs;
    6. Patients not eligible for surgical/interventional reconstruction due to technical limitations or comorbidity;
    7. No evidence of wound healing after standard of care treatment for at least 1 week before screening;
    8. In Patients suffering from 2 or more ulcers at the same extremity, these ulcers must be separated by a minimum bridge of 1 cm of epithelialized skin;
    9. If patients are hypertensive, they have to be treated with anti-hypertensive medication according to the applicable guideline;
    10. Body mass index (BMI) between 20 and 40 kg/m²;
    11. Women of childbearing potential must have a negative blood pregnancy test at screening;
    12. Women of childbearing potential and their partner must be willing to use highly effective contraceptive methods during the course of the clinical trial;
    13. Patients must be able to consent, have been informed of the nature, the scope and the relevance of the study, voluntarily agree to participation and the study’s provisions, and have duly signed the informed consent form (ICF). Subject agrees to comply with the protocol-mandated procedures and visits.
    E.4Principal exclusion criteria
    1. Patients with skin lesions of leading venous origin or patients suffering from a vasculitis;
    2. Patients with thrombangiitis obliterans;
    3. Diabetic patients in whom the leading cause for lesions is microangiopathy or neuropathy;
    4. Patients with high grade obstruction (≥ 70 %) in the aorto-iliac segment or the common femoral artery as leading cause for skin lesions;
    5. Patients with ulcers at the heel due to immobility;
    6. Patients with osteomyelitis at ulceration;
    7. Patients medicated with vitamin K antagonist, if treatment cannot be stopped before injection or bridged according to applicable guidelines;
    8. Patients medicated with DOACs, if they cannot be withheld for 24 hours before injection;
    9. Surgical/interventional reconstruction during 1 week before screening (not applicable if it becomes evident during reconstruction that revascularization is not successful: these patients can be included immediately);
    10. Patients for whom major amputation is scheduled on target leg;
    11. Patients with uncontrolled hypertension defined as systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg; For these patients a re-screening and inclusion into the study will be possible after blood pressure is controlled;
    12. Patients who had a myocardial infarction during 3 months before screening;
    13. Patients with uncontrolled infection at any of the relevant ulcers;
    14. Patients with uncontrolled acute or chronic infection with systemic symptoms;
    15. Known serious disease with life expectancy of less than 1 year;
    16. Any chronic dermatological disorders diagnosed at the investigator’s discretion;
    17. Skin disorders, unrelated to the ulcer, that are present adjacent to any of the relevant ulcers;
    18. Active malignancy or history of malignancy within 5 years prior to study entry;
    19. Patients tested positive for human immunodeficiency virus (HIV-1, HIV-2), Hepatitis B or Hepatitis C;
    20. Any known allergies to components of the IMP;
    21. Current or previous (within 30 days of enrolment) treatment with another IMP, or participation and/or under follow-up in another clinical trial;
    22. Current use of glucocorticoid-medication above Cushing threshold dose (>7.5 mg/d prednisone or equivalent) or any other prohibited medication or therapy;
    23. Known abuse of alcohol, drugs, or medicinal products;
    24. Patients anticipated to be unwilling or unable to comply with the requirements of the protocol;
    25. 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;
    26. Pregnant or lactating woman;
    27. Employees of the sponsor, or employees or relatives of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    1. Primary efficacy endpoint: Percent change from baseline to week 12 in total wound size of the target leg. The total wound size of the target leg is calculated as sum of the wound sizes of all relevant ulcers of the target leg.

    2. Primary safety endpoint: Adverse events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 12, or last available post-baseline measurement of weeks 6 or 8 if the Week 12 measurement is missing.
    2. During all patient visits except screening.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    1. Time to total healing of all relevant ulcers at target leg;
    2. Percent change in total wound size of the target leg;
    3. Absolute change in total wound size of the target leg;
    4. Ankle-brachial index (ABI) of target leg;
    5. Number of amputated toes at target leg;
    6. Time to major amputation at target leg until week 12;
    7. Epithelialization assessment of all relevant ulcers of the target leg;
    8. Assessment of formation of granulation tissue and wound exudation of all relevant ulcers of the target leg;
    9. Assessment of quality of life (QoL) using the short form 36 (SF-36) questionnaire;
    10. Pain assessment as per numerical rating scale (NRS).

    Secondary safety endpoints:
    11. Physical examination and vital signs at week 12;
    12. Laboratory assessments at Week 12
    13. Time to major amputation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints:
    1. A priori specification not possible; between baseline and week 12 post baseline;
    2. Baseline, week 1, 2, 4, 6, and 8;
    3. Baseline, week 1, 2, 4, 6, 8 and 12;
    4. Screening Visit, Baseline, Week 2, 4, 8 and 12;
    5. A priori specification not possible; between baseline and week 12 post baseline.
    6. A priori specification not possible; between baseline and week 12 post baseline.
    7. Day 0 prior IMP-application, week 2, 4, 8 and 12;
    8. Day 0 prior IMP-application, week 2, 4, 8 and 12;
    9. Day 0 prior IMP-application, week 2, 8 and 12;
    10. Day 0 prior IMP-application, week 2, 4, 8 and 12;

    Secondary safety endpoints:
    11. Week 12;
    12. Week 12;
    13. A priori specification not possible; between baseline and month 12 post baseline.
    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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 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.1.1.1In 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.1.3.1Number of subjects for this age range: 56
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 76
    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)
    After withdrawal patients will receive standard medical care according to individual needs.
    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 Decision2017-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-07
    P. End of Trial
    P.End of Trial StatusOngoing
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