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    Summary
    EudraCT Number:2021-004755-17
    Sponsor's Protocol Code Number:MYST-FACT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2023-04-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-004755-17
    A.3Full title of the trial
    PHASE I/II CLINICAL TRIAL OF ALLOGENEIC BONE MARROW DERIVED MESENCHYMAL STROMAL CELL THERAPY FOR THE PREVENTION AND TREATMENT OF PULMONARY FIBROSIS SECONDARY TO POST-INFECTIVE ARDS OR ALLOIMMUNE REACTION AFTER TRANSPLANTAT
    STUDIO CLINICO DI FASE I/II DI TERAPIA CON CELLULE STROMALI MESENCHIMALI ALLOGENICHE DA MIDOLLO OSSEO PER LA PREVENZIONE E TRATTAMENTO DELLA FIBROSI POLMONARE SECONDARIA AD ARDS POST-INFETTIVA O REAZIONI
    ALLOIMMUNI DEL TRAPIANTO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE I/II CLINICAL TRIAL OF ALLOGENEIC BM-MSC THERAPY FOR PULMONARY FIBROSIS SECONDARY TO POST-INFECTIVE ARDS OR ALLOIMMUNE REACTION AFTER TRANSPLANTATION
    STUDIO CLINICO DI FASE I/II DI TERAPIA CON BM-MSC PER LA FIBROSI POLMONARE SECONDARIA AD ARDS POST-INFETTIVA O REAZIONI ALLOIMMUNI DEL TRAPIANTO
    A.3.2Name or abbreviated title of the trial where available
    MYST-FACT
    MYST-FACT
    A.4.1Sponsor's protocol code numberMYST-FACT
    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 SponsorFONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO
    B.1.3.4CountryItaly
    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 supportMinistero della Salute
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportRegione Lombardia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Policlinico San Matteo
    B.5.2Functional name of contact pointSC AR II - CARDIOTORACICA
    B.5.3 Address:
    B.5.3.1Street AddressVIALE GOLGI, 19
    B.5.3.2Town/ cityPAVIA
    B.5.3.3Post code27100
    B.5.3.4CountryItaly
    B.5.4Telephone number0382503524
    B.5.5Fax number0382501054
    B.5.6E-mailm.belliato@smatteo.pv.it
    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 namecellule mesenchimali stromali allogeniche da midollo osseo
    D.3.2Product code [BM-MSC]
    D.3.4Pharmaceutical form Suspension for injection
    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.3.9.2Current sponsor codeBM-MSC
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000
    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 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
    PULMONARY FIBROSIS SECONDARY TO ARDS OR ALLOIMMUNE REACTION AFTER TRANSPLANTATION
    FIBROSI POLMONARE SECONDARIA AD ARDS POST-INFETTIVA O REAZIONI ALLOIMMUNI DEL TRAPIANTO
    E.1.1.1Medical condition in easily understood language
    PULMONARY FIBROSIS SECONDARY TO ARDS OR ALLOIMMUNE REACTION AFTER TRANSPLANTATION
    FIBROSI POLMONARE SECONDARIA AD ARDS POST-INFETTIVA O REAZIONI ALLOIMMUNI DEL TRAPIANTO
    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 LLT
    E.1.2Classification code 10022619
    E.1.2Term Interstitial pulmonary fibrosis
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety of MSC treatment.
    For cohort A: any case of venous thromboembolism (VTE) or pulmonary
    embolism (PE), in the 48 hour period following MSC infusion.
    For cohort B: number of new onset infections and colonisations in the first 3
    months after MSC therapy start.
    Sicurezza del trattamento con MSC.
    Per il gruppo A: ogni caso di trombo-embolia venosa (VTE) o embolia
    polmonare (PE), nelle prime 48 ore dall’infusione di MSC.
    Per il gruppo B: numero di nuove infezioni o colonizzazioni nei tre mesi dopo
    l’inizio della terapia con MSC.
    E.2.2Secondary objectives of the trial
    Initial efficacy of MSC therapy.
    For cohort A:
    Key secondary endpoint: clinical improvement over a period of 1 month, defined as decrease in WHO scale score by 2 points on the ten-category ordinal scale or discharged alive from the hospital, whichever comes first
    For cohort B:
    Key secondary endpoint: Lung function stabilization, defined as = 15% decline of FEV1 over the 6 months post-treatment with respect to baseline values.
    In cohort B2, for patients not evaluable with lung function tests (i.e., young children), change in HR lung CT scan pattern, measured as differential % inflated areas pre- post-treatment, will be used.
    Iniziale efficacia della terapia con MSC.
    Per gruppo A:
    Key Endpoint secondario: miglioramento clinico entro 1 mese dall’inizio del trattamento, definito come diminuzione di almeno due punti sulla scala di score WHO o dimissione dall’ospedale, in base all’evento che si verifica per primo.
    Per gruppo B:
    Key Endpoint secondario: Stabilizzazione della funzionalità polmonare, definita come riduzione di FEV1 =15% nei 6 mesi dall’inizio del trattamento, rispetto al valore basale.
    Nel gruppo B2, per i pazienti non valutabili mediante I test funzionali (i.e. bambini età pre-scolare), modifiche nel pattern della HRCT polmonare, misurati come ratio % delle aree infiltrate pre e post trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for cohort A:
    ¿ Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
    ¿ Male or female adults at time of enrolment age < 75 years old
    ¿ Patient hospitalized for acute bacterial/viral pneumonia with CT scan finding clear evidence of ARDS in late proliferative phase, unresponsive to a steroid course despite a decrease in inflammatory markers, and with residual area of “crazy paving” and/or “ground glass opacity”, as markers of non irreversible parenchymal lesions.
    ¿ Hypoxic patient with a P/F = 200 while breathing room air or supplemental oxygen and requiring positive pressure respiratory support, either non invasive (helmet/mask CPAP or NIV) or invasive (endotracheal intubation and mechanical ventilation) and/or hypercapnic due to low respiratory system compliance (Crs < 0,5 ml/cmH2O/Kg).

    Inclusion criteria for cohort B1:
    ¿ Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
    ¿ Male or female adult patients at time of enrolment.
    ¿ Patients experiencing graft function decline and meeting criteria for CLAD diagnosis according to International consensus, and unresponsive (NOT improving/stabilizing) to previous first- and second-line treatment.

    Inclusion criteria for cohort B2:
    ¿ Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written reconsent by patient or representatives will be obtained as soon as possible.
    ¿ Patients with moderate or severe lung cGVHD according to International NIH consensus, after failure of 1 or more lines of systemic therapy.
    ¿ Male or female patients older than 1 year of age at time of enrolment.
    Criteri di inclusione per il gruppo A:
    ¿ Consenso informato scritto. Il consenso orale sarà accettato ove necessario. Il consenso scritto da parte del paziente o di un legale rappresentante sarà raccolto appena possibile.
    ¿ Pazienti adulti di sesso maschile o femminile con età <75 anni al momento dell’arruolamento.
    ¿ Pazienti ricoverati per polmoniti batteriche o virali acute con evidenza, all’esame CT polmonare, di ARDS in fase proliferativa tardiva, non responsivi ad almeno un ciclo di steroide e con segni di lesioni parenchimali non irreversibili, quali aree di “crazy paving” e/o di opacità a vetro smerigliato.
    ¿ Paziente ipossico con P/F = 200 in aria ambiente o in supplemento d’ossigeno , che richiede supporto respiratorio a pressione positiva, non invasiva (CPAP o NIV) o invasiva (intubazione endotracheale e ventilazione meccanica), e/o ipercapnico per bassa compliance respiratoria (Crs < 0,5 ml/cmH2O/Kg).

    Criteri di inclusione per gruppo B1:
    ¿ Consenso informato scritto. Il consenso orale sarà accettato ove necessario. Il consenso scritto da parte del paziente o di un legale rappresentante sarà raccolto appena possibile.
    ¿ Pazienti adulti di sesso maschile o femminile.
    ¿ Pazienti con diminuzione della funzionalità del trapianto che rispondono ai criteri per la diagnosi di CLAD in accordo con Consensus Internazionale, e non responsive (NON in miglioramento/stabilizzazione) a precedenti prima e seconda linea di trattamento.

    Criteri di inclusione per gruppo B2:
    ¿ Consenso informato scritto. Il consenso orale sarà accettato ove necessario. Il consenso scritto da parte del paziente o di un legale rappresentante sarà raccolto appena possibile.
    ¿ Pazienti con cGVHD polmonare moderata o grave in accordo con consensus internazionale NIH, dopo il fallimento di una o più linee di terapia sistemica.
    ¿ Pazienti maschi o femmine di età > 1 anno al momento dell’arruolamento.
    E.4Principal exclusion criteria
    Exclusion criteria for cohort A
    ¿ Patients who received an investigational agent within 28 days before enrolment.
    ¿ In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
    ¿ Stage 3 and 4 severe chronic kidney disease or requiring dialysis.
    ¿ Pregnancy
    ¿ Current documented and uncontrolled bacterial infection or septic shock.
    ¿ Imminent need of an ECMO or ECCO2R support
    ¿ Ongoing ECMO or ECCO2R support
    ¿ Late stage ARDS with CT scan indicating clear finding of advanced fibrosis in a major part of the lung tissues.

    Exclusion criteria for cohort B1
    ¿ Patients who received an investigational agent within 28 days before enrolment.
    ¿ Any uncontrolled active systemic infection or active infection requiring systemic treatment that is ongoing = 7 days before enrolment. This does not include secondary prophylaxis of well controlled fungal infections, ongoing treatment of controlled viral reactivations (e.g., CMV), or treatment or prophylaxis of controlled low grade central line infections (e.g., Staphylococcus epidermidis).
    ¿ Any subject with a concurrent illness which in the opinion of the investigator may interfere with the treatment and evaluation of the subject.
    ¿ Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk.
    ¿ Female subject who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months of the last dose of study drug. Male subject who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug.

    Exclusion criteria for cohort B2
    ¿ Patients who received an investigational agent within 28 days before enrolment.
    ¿ Any uncontrolled active systemic infection or active infection requiring systemic treatment that is ongoing = 7 days before enrolment. This does not include secondary prophylaxis of well controlled fungal infections, ongoing treatment of controlled viral reactivations (e.g., CMV), or treatment or prophylaxis of controlled low grade central line infections (e.g., Staphylococcus epidermidis).
    ¿ Progressive underlying malignant disease or active post-transplant lymphoproliferative disease.
    ¿ Any subject with a concurrent illness which in the opinion of the investigator may interfere with the treatment and evaluation of the subject.
    ¿ Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk.
    ¿ Female subject who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months of the last dose of study drug. Male subject who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug.
    Criteri di esclusione per il gruppo A
    ¿ Pazienti trattati con un farmaco sperimentale entro i 28 giorni dall’arruolamento
    ¿ Su parere del team clinico, prognosi infausta nelle successive 24 ore, indipendentemente dal trattamento.
    ¿ Tossicità renale cronica di grado 3 o 4, o che necessita di dialisi.
    ¿ Gravidanza
    ¿ Infezione batterica documentata e non controllata o shock settico.
    ¿ Imminente necessità di supporto ECMO o ECCO2R
    ¿ Pazienti in supporto ECMO or ECCO2R
    ¿ ARDS in stadio avanzato con fibrosi diffusa nella gran parte del tessuto polmonare

    Criteri di esclusione per il gruppo B1
    ¿ Pazienti trattati con un farmaco sperimentale entro i 28 giorni dall’arruolamento
    ¿ Qualsiasi infezione sistemica attiva non controllata o infezione attiva che richiede un trattamento sistemico, in corso da =7 giorni dall’arruolamento. Non è un criterio di esclusione la presenza di infezione fungina ben controllate in profilassi secondaria, un trattamento farmacologico di una infezione/riattivazione virale controllata (e.g., CMV), o la profilassi/trattamento di una infezione batterica controllata del catetere venoso centrale (e.g., Staphylococcus epidermidis).
    ¿ Soggetti con malattie concomitanti che secondo il clinico possono interferire con il trattamento e/o la valutazione dei risultati.
    ¿ Patologie, condizioni mediche o disfunzioni d’organo severe, che secondo il parere del clinico potrebbero compromettere la sicurezza del paziente o interferire con i risultati dello studio.
    ¿ Pazienti di sesso femminile in gravidanza, in corso di allattamento o che pianificano una gravidanza durante l’arruolamento o entro 3 mesi dall’ultima dose. Soggetti di sesso maschile intenzionati alla paternità nel corso della partecipazione allo studio o entro tre mesi dall’ultima dose.

    Criteri di esclusione per il gruppo B2
    ¿ Pazienti trattati con un farmaco sperimentale entro i 28 giorni dall’arruolamento
    ¿ Qualsiasi infezione sistemica attiva non controllata o infezione attiva che richiede un trattamento sistemico, in corso da =7 giorni dall’arruolamento. Non è un criterio di esclusione la presenza di infezione fungina ben controllate in profilassi secondaria, un trattamento farmacologico di una infezione/riattivazione virale controllata (e.g., CMV), o la profilassi/trattamento di una infezione batterica controllata del catetere venoso centrale (e.g., Staphylococcus epidermidis).
    ¿ Malattia neoplastica di base in progressione o malattia linfoproliferativa post-trapianto attiva.
    ¿ Soggetti con malattie concomitanti che secondo il clinico possono interferire con il trattamento e/o la valutazione dei risultati.
    ¿ Patologie, condizioni mediche o disfunzioni d’organo severe, che secondo il parere del clinico potrebbero compromettere la sicurezza del paziente o interferire con i risultati dello studio.
    ¿ Pazienti di sesso femminile in gravidanza, in corso di allattamento o che pianificano una gravidanza durante l’arruolamento o entro 3 mesi dall’ultima dose. Soggetti di sesso maschile intenzionati alla paternità nel corso della partecipazione allo studio o entro tre mesi dall’ultima dose.
    E.5 End points
    E.5.1Primary end point(s)
    Safety of MSC treatment.
    For cohort A: any case of venous thromboembolism (VTE) or pulmonary embolism (PE), in the 48 hour period following MSC infusion.
    For cohort B: number of new onset infections and colonisations in the first 3 months after MSC therapy start.
    Sicurezza del trattamento con MSC.
    Per il gruppo A: ogni caso di trombo-embolia venosa (VTE) o embolia polmonare (PE), nelle prime 48 ore dall’infusione di MSC.
    Per il gruppo B: numero di nuove infezioni o colonizzazioni nei tre mesi dopo l’inizio della terapia con MSC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For cohort A: any case of venous thromboembolism (VTE) or pulmonary embolism (PE), in the 48 hour period following MSC infusion.
    For cohort B: number of new onset infections and colonisations in the first 3 months after MSC therapy start.
    Per il gruppo A: ogni caso di trombo-embolia venosa (VTE) o embolia polmonare (PE), nelle prime 48 ore dall’infusione di MSC.
    Per il gruppo B: numero di nuove infezioni o colonizzazioni nei tre mesi dopo l’inizio della terapia con MSC.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    phase I/II
    fase I/II
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    studio in aperto, non randomizzato
    open-label, non-randomized trial
    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 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 concerned2
    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 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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 Yes
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 3
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    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: 5
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2023-04-05. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    patients undergoing intubation, sedation and mechanical ventilation
    pazienti intubati, sedati e sottoposti a ventilazione meccanica
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    oncologic patients and subjects with chronic transplant-related pahologies
    pazienti oncologici o con patologie croniche del trapianto
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    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)
    standard of care
    standard di cura
    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 Decision2024-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2025-01-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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