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    Summary
    EudraCT Number:2019-004462-18
    Sponsor's Protocol Code Number:ARDS-MSC-205
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-23
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-004462-18
    A.3Full title of the trial
    MESENCHYMAL STROMAL CELL THERAPY FOR THE TREATMENT OF ACUTE RESPIRATORY DISTRESS SYNDROME
    Validation of Mechanistic Pathways and Clinical Efficacy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MESENCHYMAL STROMAL CELL THERAPY FOR THE TREATMENT OF ACUTE RESPIRATORY DISTRESS SYNDROME
    Behandling av svår chocklunga med mesenkymala stromaceller
    A.4.1Sponsor's protocol code numberARDS-MSC-205
    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 SponsorUppsala University Hospital
    B.1.3.4CountrySweden
    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 supportUppsala University Hospital
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportKarolinska Institutet
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportSwedish StromaBio AB
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportUppsala University
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSwedish StromaBio AB
    B.5.2Functional name of contact pointIda Duprez
    B.5.3 Address:
    B.5.3.1Street AddressStockholmsvägen 33
    B.5.3.2Town/ cityLidingö
    B.5.3.3Post code18133
    B.5.3.4CountrySweden
    B.5.4Telephone number+460734026696
    B.5.6E-mailida.duprez@stromabio.se
    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 nameKI-MSC-PL-205
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot established
    D.3.9.2Current sponsor codeKI-MSC-PL-205
    D.3.9.3Other descriptive nameMesenchymal stromal cells, ex vivo cultured
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typeequal
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberWe have not asked for a specific recommendation for our product. General recommendation for allogeneic BM-MSC: EMA/864885/2016 (but for other indication)
    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
    Acute respiratory distress syndrome (ARDS)
    E.1.1.1Medical condition in easily understood language
    Acute respiratory distress syndrome (ARDS)
    Chocklunga
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate safety and tolerability after administration of KI-MSC-PL-205 concomitant to respirator support
    E.2.2Secondary objectives of the trial
    To evaluate all-cause mortality

    To evaluate effect on respiratory, systemic and biological efficacy endpoints after infusion of KI-MSC-PL-205 concomitant to respirator support

    To evaluate the potenial difference in number of AE between the two dose groups
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide written informed consent prior to performing study procedures (and have given written consent)

    2. Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test at screening

    3. Male or female patient aged 18 to 65 years old

    4.Patient must fulfil the Berlin Definition of severe ARDS within 3 weeks to 48 hours prior to inclusion (Will be assessed once the patient has been admitted to the ICU)

    5. Patient is on respirator support within 3 weeks to 48 hours prior to inclusion (Will be assessed once the patient has been admitted to the ICU)

    6. Pregnancy test in blood confirming negative results before enrolment (for women ≤55 years old)
    E.4Principal exclusion criteria
    1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient’s ability to participate in the study

    2. Patients with history of treated blood and/or solid organ malignancy with recurrence within five years prior to dosing of the ATIMP are to be excluded. Patients with history of cervix cancer and non-melanoma skin cancer with recurrence within two years prior to dosing of the ATIMP are to be excluded

    3. Pregnant or breast feeding female

    4. Patient with a history of anti-coagulation therapy for other indications that short-term prophylaxis after surgery.

    5. Patients with a history and/ or on-going treatment for entity associated with bleeding disorder or potential risk for bleeding (e.g. inflammatory bowel disease, gastro-esophagitis with or without ulcers, haemophilia and other bleeding disorders, inflammatory musculo-skeletal disease with potential bleeding complications).

    6. Patients with a history during the latest five years and/or on-going treatment for systemic infection (e.g. Septicaemia due to in vivo foreign body (e.g. stents, catheters, heart valve), tuberculosis, malaria, other opportunistic and parasite infections).

    7. Prisoner

    8. Any other irreversible disease or condition for which six-month mortality is estimated to be greater than 50%

    9. Moderate to severe liver failure (Child-Pugh Score >12)

    10. Reduced renal function with a creatinine clearance (Cockcroft-Gault Equation) < 45 mL/min/1.73m2

    11. Severe chronic respiratory disease with a PaCO2 >50 mmHg or the use of home oxygen

    12. Major trauma in the prior 5 days

    13. Lung transplant patient

    14. Patients on ECMO-support

    15. Patients with a previous history of severe burns

    16. Documented deep venous thrombosis or pulmonary embolism within past three months

    17. Known hypersensitivity to DMSO

    18.
    Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements
    E.5 End points
    E.5.1Primary end point(s)
    The incidence of pre-specified treatment related adverse events of interest (TRAEIs) occurring during the 10 days interval beginning with the start of the ATIMP infusion:
    - New ventricular tachycardia, ventricular fibrillation or asystole within 10 days after infusion
    - New cardiac arrhythmia requiring cardioversion within 10 days after infusion
    - Cardiac arrest or death within 10 days after infusion
    - Clinical scenario consistent with transfusion incompatibility or transfusion-related infection within 10 days after infusion
    - Thromboembolic events (e.g. Pulmonary embolism) within 10 days after infusion
    E.5.1.1Timepoint(s) of evaluation of this end point
    For 10 days after infusion of ATIMP
    E.5.2Secondary end point(s)
    Secondary safety endpoints
    - Frequency, intensity and seriousness of AEs between the two dose groups during the whole study period
    - Changes from baseline (Day 1; prior to administration of ATIMP) in the safety laboratory samples (haematology, coagulation and biochemistry parameters)
    - Changes from baseline (Day 1; prior to administration of ATIMP) in vital signs and in significant findings at physical examination
    - All-cause mortality (at 60 days and then annually)
    Secondary efficacy endpoints
    - Changes from baseline (Day 1; prior to administration of ATIMP) in pulmonary compliance (dynamic and static), driving pressure (Plateau pressure- PEEP), oxygenation (PaO2/FiO2) until maximum day 10 (or earlier at extubation)
    - Duration of respirator support (number of days after infusion)
    - Changes in amount of pulmonary bilateral infiltrates assessed by pulmonary X-ray from baseline (Day 1; prior to administration of ATIMP) until day 60
    - Recovery of lung function assessed by Spirometry (FEV1, Vital Capacity) at day 60 and then annually
    - To assess development of lung fibrosis using the HRCT Fibrosis Score using Computed tomography (CT) at baseline and on day 1, 3, 7, 10, end of ICU-residence, end of hospital stay, day 60, 6 month and 12 month and end of study (if possible during the infectious stage depending on hospital safety regimen during the pandemic).
    - Changes in Sequential Organ Failure Assessment (SOFA) score from baseline (Day 1; prior to administration of ATIMP) and during the ICU-period
    - Number of respirator free days (Day 60)
    - Duration of ICU stay and hospital stay (number of days; whole hospital period + calculated from Day 1)
    - Assessment of the patient’s physical capacity by 6-Minute-Walk-Test (6MWT), starting at 6 months post Day 1 and then annually
    - Changes in Quality of Life by assessing the Short Form Health Survey (SF-36) score (starting at 6 months post Day 1 and then annually; patient reported outcome)
    - Change in blood biomarkers related to the proposed mechanisms of action of KI-MSC-PL-205 in ARDS
    - Sensitisation tests (test for donor-specific antibodies) against KI-MSC-PL-205 donor
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints are assessed for up to 5 years (end-of-trial)
    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 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) Yes
    E.7.1.1First administration to humans Yes
    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 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.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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 the treatment phase is defined as the date of Visit 6 (6 months post-infusion) of the last patient. The end of the study is defined as the date of the last visit of the last patient in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state9
    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)
    Same treatment as for any ARDS survivor
    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 Decision2020-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
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