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    Summary
    EudraCT Number:2017-002462-41
    Sponsor's Protocol Code Number:TBRU-dS-RAC-PII
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-13
    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 number2017-002462-41
    A.3Full title of the trial
    A Phase II, prospective, intra-patient randomized controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of full thickness skin defects in adults and children in comparison to autologous split-thickness skin grafts (STSG)
    Studio multicentrico, prospettico, randomizzato e controllato intra-paziente, di fase II, sulla sicurezza ed efficacia di un sostituto cutaneo dermoepidermico bioingegnerizzato (EHSGKF) per il trattamento di difetti cutanei a spessore completo negli adulti e nei bambini, in confronto con l'innesto di cute a spessore parziale autologa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to check if the use of a skin model engeneered in the laboratory by
    using your own skin cells (EHSG-KF), is safe and effective to treat partial
    deep dermal and full thickness skin defects in adults and children in comparison to autologous split-thickness skin grafts (STSG)
    Studio di valutazione dell'utilizzo di un modello cutaneo ingegnerizzato in
    laboratorio a partire dalle cellule del paziente (EHSG-KF), per quanto
    riguarda sicurezza ed efficacia, nel trattamento di difetti cutanei a spessore completo negli adulti e nei bambini, in confronto con l'innesto di cute a spessore parziale autologa.
    A.4.1Sponsor's protocol code numberTBRU-dS-RAC-PII
    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 SponsorUniversity of Zurich, Tissue Biology Research Unit
    B.1.3.4CountrySwitzerland
    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 supportWyss Zurich
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Zurich
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressWeinbergstrasse 35
    B.5.3.2Town/ cityZurich
    B.5.3.3Post code8092
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 446328261
    B.5.6E-mailFabienne.Hartmann-fritsch@wysszurich.ch
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1596
    D.3 Description of the IMP
    D.3.1Product nameEHSG-KF
    D.3.2Product code EHSG-KF
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAutogolous Skin Cells
    D.3.9.1CAS number na
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameHuman Autologous Skin Cells
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 10000000
    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 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 numberH0004817
    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
    Adults and children with full thickness skin defects.
    Adulti e bambini con difetti cutanei a spessore completo.
    E.1.1.1Medical condition in easily understood language
    Adults and children with full thickness skin defects.
    Adulti e bambini con difetti cutanei a spessore completo.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    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 EHSG-KF in comparison to STSG based on
    the assessment of:
     Scar quality:
    o POSAS questionnaire, observer total score 3 months post grafting
    Valutare l'efficacia di EHSG-KF rispetto all'innesto a rete di cute a spessore parziale in termini di:
     Qualità della cicatrice, tramite questionario POSAS (score totale osservatore) dopo 3 mesi dall'innesto;
    E.2.2Secondary objectives of the trial
    To evaluate the safety and efficacy of EHSG-KF in comparison to
    meshed STSG based on the assessment of:
     Scar quality:
    o Cutometer® 3 months post grafting
    o POSAS questionnaire, observer items 3 months post grafting
    o POSAS questionnaire, patient items and total score 3 months post grafting
    o DSM II ColorMeter® at visit 10 (1 year +/-30 days post grafting)
    o Optional biopsies of the study area and control area at visit 10 (1 year +/-30 days post grafting) for histological assessment. (optional)
     Infection 4-11 days and 21 +/- 2 days post grafting
     Graft take at 4-11 days post grafting
     % Epithelialization at 28 days +/- 3 days post grafting
     Adverse events
     QOL assessment at visit 10 (1 year +/-30 days) after grafting
    o EQ-5D and BSHS-B for adults with reconstruction of burn scars,
    o EQ-5D only for all other adults,
    o EQ-5DY and PedsQL for all children i.e. patients who haven’t reached their 18th birthday on the day of screening
    Valutare sicurezza e efficacia di EHSG-KF rispetto all'innesto a rete di cute a spessore parziale in termini di:
    • Qualità della cicatrice (dopo 3 mesi):
    o Cutometer®
    o Questionario POSAS (score singoli osservatore)
    o Questionario POSAS (score singoli paziente e score totale)
    o DSM II ColorMeter® alla v10 (dopo 1 anno +/-30 giorni)
    o Biopsie opzionali a livello dell’area studiata e dell’area di controllo alla visita 10 (dopo 1 anno +/-30 giorni) per analisi istologiche opzionali
    • Infezioni dopo 4-11 giorni e 21 +/- 2 giorni
    • Adesione dell'innesto dopo 4-11 giorni
    • % epitelializzazione dopo 28 +/- 3 giorni
    • Valutazione degli eventi avversi
    • Crescita (% di cambiamento area superficiale, cm2, tra 1 e 3 anni)
    • Valutazione qualità di vita alla v10 (dopo 1 anno +/-30 giorni):
    o EQ-5D e BSHS-B per adulti sottoposti a ricostruzione cicatrici da ustione
    o solo EQ-5D per gli altri adulti
    o EQ-5DY e PedsQL per i pazienti < 18 anni al momento dello screening
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Age: ≥1 year of age
     Large full-thickness defects that require coverage after excision
    of:
    o Scars
    o Benign skin tumors (e.g. neurofibroma)
    o Melanocytic nevus (e.g. giant nevus)
    o Gender reassignment surgery
    o Soft tissue defect after trauma
    o Soft tissue defect after infection and debridement (e.g.
    necrotizing fascitis, hidradentitis suppurativa, purpura
    fulminans)
    o Flap donorsite (e.g. radial forearm flap)
     Minimal areas requiring coverage (not counting the head and neck
    area for study patients in The Netherlands):
    o Minimum: 1-5 y: 9 cm2
    o Minimum: 6-16 years: 25 cm2
    o Minimum: > 16 years: 45 cm2
     Signed Informed consent from the patient or the legally authorized
    representative.
     Età: ≥ 1 anni di età;
     Difetto cutaneo esteso a tutto spessore derivante dall'escissione chirurgica di:
    o cicatrici;
    o tumori benigni alla cute (es. neurofribroma);
    o nevi melanocitici (es. nevi giganti);
    o riassegnazione chirurgica dei caratteri sessuali;
    o danni dei tessuti molli dopo un trauma;
    o danni dei tessuti molli dopo infezione e relativa pulizia (es. fascite necrotizzante, idrosadenite suppurativa, porpora fulminante);
    o lembo del sito donatore (es. lembo radiale del braccio);
     Dimensioni minime delle aree che richiedono una copertura (non comprese le aree del capo e del collo per quanto riguarda i pazienti arruolati in Olanda):
    o Minimo: 1-5 anni: 9 cm2;
    o Minimo: 6-16 anni: 25 cm2;
    o Minimo: > 16 anni: 45 cm2;
     Consenso informato firmato da parte del paziente o del legale rappresentante.
    E.4Principal exclusion criteria
     Patients tested positive for HBV, HCV, syphilis or HIV
     Patients with known underlying or concomitant medical conditions
    that may interfere with normal wound healing (e.g. systemic skin
    and connective tissue diseases, any kind of congenital defect of
    metabolism including insulin-dependent diabetes mellitus,
    Cushing syndrome or disease, scurvy, chronic hypothyroidism,
    congenital or acquired immunosuppressive condition, chronic
    renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the
    opinion of the Investigator, has the potential to significantly delay
    wound healing)
     Severe drug and alcohol abuse
     Pre-existing coagulation disorders as defined by INR outside its
    normal value, PTT >ULN and fibrinogen <LLN prior to the current
    hospital admission and / or at the Investigator’s discretion
     Patients allergic to amphotericin B and gentamicin
     Previous enrolment of the patient into the current phase II study
     Participation of the patient in another study with conflicting
    endpoints within 30 days preceding and during the present study
     Patients expected not to comply with the study protocol (including
    patients with severe cognitive dysfunction/impairment and severe
    psychiatric disorders)
     Pregnant or breast feeding females
     Intention to become pregnant during the clinical course of the
    study (12 months)
     Wounds in the head and neck area as study target area (only
    applicable for study patients in The Netherlands)
     Enrolment of the Investigator, his/her family members, employees
    and other dependent persons
     Pazienti positivi ai test per HBV, HCV, sifilide o HIV;
     Pazienti che presentano patologie preesistenti o concomitanti che potrebbero interferire con il normale processo di guarigione della ferita (p. es. malattie sistemiche della cute e dei tessuti connettivi, qualsiasi tipo di difetto congenito del metabolismo, compresi diabete mellito insulino-dipendente, sindrome o malattia di Cushing, scorbuto, ipotiroidismo cronico, immunodepressione congenita o acquisita, insufficienza renale cronica o insufficienza epatica cronica (Child-Pugh di classe B o C), malnutrizione grave, o altre infermità concomitanti che, nell'opinione del Ricercatore, possono potenzialmente provocare ritardi significativi nella guarigione della ferita);
     Grave abuso di alcool e droghe;
     Disturbi della coagulazione pre-esistenti, ovvero con INR fuori dal normale range di valori, PTT>ULN e fibrinogeno <LLN prima del ricovero ospedaliero e/o a discrezione del ricercatore;
     Pazienti allergici ad amfotericina B e gentamicina;
     Precedente partecipazione del paziente al presente studio di fase II;
     Partecipazione del paziente ad altro studio i cui endpoint siano in conflitto con quelli del presente studio nei 30 giorni precedenti questo studio, o nel corso dello stesso;
     Pazienti che non si ritiene siano in grado di rispettare il protocollo dello studio (compresi pazienti con gravi disabilità/disturbi cognitivi e gravi disturbi psichiatrici);
     Pazienti femmine in stato di gravidanza o in allattamento;
     Pazienti femmine con Intenzione di avviare una gravidanza nel corso dello studio clinico (12 mesi);
     Ferite nell'area del capo e del collo (soltanto per i pazienti arruolati in Olanda);
     Arruolamento del medico ricercatore, dei suoi familiari, dipendenti o altre persone correlate.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy evaluation, as a comparison between the EHSG-KF and control
    sites, based on assessment of general scar quality at the study areas using the POSAS questionnaire, observer total score at: visit 8 (90 days +/-5 days post grafting)
    Confronto tra EHSG-KF ed i siti di controllo per una valutazione dell'efficacia basata sulla valutazione della qualitá generale della cicatrice a livello dell’area studiata, tramite questionario POSAS (score totale osservatore) durante la visita 8 (90 giorni +/- 5 giorni dopo l'innesto).
    E.5.1.1Timepoint(s) of evaluation of this end point
    o visit 8 (90 +/-5 days post grafting)
    o visita 8 (90 +/- 5 giorni dopo l'innesto)
    E.5.2Secondary end point(s)
    Efficacy evaluation, as a comparison between the EHSG-KF and control
    sites, based on:
     Scar quality at the study areas in comparison to control areas:
    o Cutometer® pliability parameter at visit 8 (90 days +/-5
    days post grafting) as key secondary efficacy endpoint
    o Other Cutometer® parameters (extension, elasticity,
    retraction, viscoelasticity) at visit 8 (90 days +/-5 days post
    grafting)
    o POSAS questionnaire observer items (vascularity,
    pigmentation, thickness, relief, pliability) at visit 8 (90 days
    +/-5 days post grafting)
    o POSAS questionnaire patient items (pain, itching, color,
    pliability, thickness, relief) and total score at visit 8 (90
    days +/-5 days after grafting)
    o DSM II ColorMeter® (erythema and pigmentation) at: visit
    10 (1 year +/-30 days post grafting)
    o Optional biopsies of the study area and control area at
    visit 10 (1 year +/-30 days after grafting) for histological
    assessment. (optional)
    o Graft take at Visit 4 (4-11 days after grafting)
    o % Epithelialization at Visit 6 ( 28 days +/- 3 days after
    grafting)
    Secondary safety endpoints:
     Clinical and microbiologic signs of infection at
    o visits 4 (4-11 days post grafting)
    o visit 5 (21 +/-2 days post grafting)
     Adverse events
    o Assessment and reporting of all adverse events
    (expected and unexpected) will be carried out for the full
    duration of the study
    Other secondary efficacy endpoint:
     QOL assessment: visit 10 (1 year +/-30 days post grafting)
    o EQ-5D and BSHS-B for adults with reconstruction of a
    burn scar
    o EQ-5D only for patients without burn scars
    o EQ-5DY and PedsQL for children (patients who haven’t
    reached their 18th birthday on screening day)
    Exploratory Endpoints
     % Epithelialization (to estimate time to complete epithelialization)
    at:
    o visit 5 (21 +/-2 days post grafting)
    o visit 7 (60 +/-3 days post grafting)
    o visit 8 (90 +/-5 days post grafting)
    o visit 9 (6months +/-10 days post grafting)
     Clinical and microbiologic signs of infection at:
    o visit 6 (28 +/-3 days post grafting)
     Cutometer® parameters at
    o visit 9 (6 months +/-10 days post grafting)
    o visit 10 (1 year +/-30 days post grafting)
    o visit 11 (2 years +/-30 days post grafting)
    o visit 12 (3 years +/-30 days post grafting)
     Assessment of general scar quality at the study areas using the
    POSAS questionnaire, at:
    o visit 9 (6 months +/-10 days post grafting)
    o visit 10 (1 year +/-30 days post grafting)
    o visit 11 (2 years +/-30 days post grafting)
    o visit 12 (3 years +/-30 days post grafting)
     Assessment of colour of the study areas using the DSM II
    ColorMeter® at:
    o visit 8 (90 +/-5 days post grafting)
    o visit 9 (6 months +/-10 days post grafting)
    o visit 11 (2 years +/-30 days post grafting)
    o visit 12 (3 years +/-30 days post grafting)
     Growth (% change in surface area, cm2 , between 1 and 3 years
    post grafting)
     QOL assessment at:
    o visit 3 (day of grafting)
    o visit 8 (90 +/-5 days post grafting)
    o visit 9 (6 months +/-10 days post grafting)
    o visit 11 (2 years +/-30 days post grafting)
    o visit 12 (3 years +/-30 days post grafting
    Confronto tra EHSG-KF ed i siti di controllo per una valutazione dell'efficacia basata su:
     Qualità della cicatrice a livello delle porzioni cutanee studiate in comparazione con le aree di controllo:
    o Valutazione della flessibilitá tramite Cutometer® alla visita 8 (90 giorni +/-5 giorni dopo l'innesto) come endpoint secondario principale di sicurezza;
    o Valutazione di altri parametri (estensione, elasticità, retrazione, viscoelasticità) tramite Cutometer® alla visita 8 (90 giorni +/-5 giorni dopo l'innesto);
    o Valutazione della qualità generale della cicatrice tramite questionario POSAS (score singoli osservatore - vascolarizzazione, pigmentazione, spessore, rilievo, flessibilità) alla visita 8 (90 giorni +/-5 giorni dopo l'innesto);
    o Valutazione della qualità generale della cicatrice tramite questionario POSAS (score singoli paziente - dolore, prurito, colore, flessibilità, spessore, rilievo e score totale) alla visita 8 (90 giorni +/-5 giorni dopo l'innesto);
    o DSM II ColorMeter® (eritema e pigmentazione) alla visita 10 (1 anno +/-30 giorni dopo l'innesto);
    o Biopsie opzionali a livello dell’area studiata e dell’area di controllo alla visita 10 (1 anno +/-30 giorni dopo l'innesto) per analisi istologiche – opzionali;
    o Adesione dell'innesto 4-11 giorni dopo l'intervento;
    o % di epitelializzazione alla visita 6 (28 +/- 3 giorni dopo l'innesto);
     Endpoint secondari di sicurezza:
    o Evidenze cliniche e microbiologiche di infezioni in occasione di:
    - visita 4 (4-11 giorni dopo l'innesto);
    - visita 5 (21 +/- 2 giorni dopo l'innesto);
    o Eventi avversi: nel corso dell'intera durata dello studio verranno valutati e registrati tutti gli eventi avversi (previsti e imprevisti);
     Endpoint secondari di efficacia:
    o Valutazione qualità della vita alla visita 10 (1 anno +/-30 giorni dopo l'innesto), tramite:
    - questionari EQ-5D e BSHS-B per pazienti adulti sottoposti a ricostruzione delle cicatrici da ustione;
    - solo il questionario EQ-5D per tutti gli altri pazienti adulti;
    - questionari EQ-5DY e PedsQL per tutti i pazienti che, al momento dello screening, non hanno ancora compiuto 18 anni di etá;
    Endpoint esplorativi:
     % di epitelializzazione (per effettuare una stima del "tempo necessario per la completa epitelializzazione"), con rilevamenti alle seguenti visite:
    o visita 5 (21 +/- 2 giorni dopo l'innesto);
    o visita 7 (60 +/- 3 giorni dopo l'innesto);
    o visita 8 (90 +/- 5 giorni dopo l'innesto);
    o visita 9 (6 mesi +/- 10 giorni dopo l'innesto);
     Evidenze cliniche e microbiologiche di infezioni, con rilevamento alla visita 6 (28 +/- 3 giorni dopo l'innesto);
     Valutazione dei parametri misurati tramite Cutometer®, con rilevamenti alle seguenti visite:
    o visita 9 (6 mesi +/- 10 giorni dopo l'innesto);
    o visita 10 (1 anno +/-30 giorni dopo l'innesto);
    o visita 11 (2 anni +/- 30 giorni dopo l'innesto);
    o visita 12 (3 anni +/- 30 giorni dopo l'innesto);
     Valutazione della qualità generale della cicatrice in corrispondenza delle porzioni cutanee studiate tramite questionario POSAS, con rilevamenti alle seguenti visite:
    o visita 9 (6 mesi +/- 10 giorni dopo l'innesto);
    o visita 10 (1 anno +/-30 giorni dopo l'innesto);
    o visita 11 (2 anni +/- 30 giorni dopo l'innesto);
    o visita 12 (3 anni +/- 30 giorni dopo l'innesto);
     Valutazione del colore (eritema e pigmentazione) delle porzioni cutanee studiate tramite DSM II ColorMeter®, con rilevamenti alle seguenti visite:
    o visita 8 (90 +/- 5 giorni dopo l'innesto);
    o visita 9 (6 mesi +/- 10 giorni dopo l'innesto);
    o visita 11 (2 anni +/- 30 giorni dopo l'innesto);
    o visita 12 (3 anni +/- 30 giorni dopo l'innesto);
     Crescita (% di cambiamento area superficiale, cm2, tra 1 e 3 anni dopo l'innesto;
     Valutazione della qualità della vita del paziente (questionari EQ-5D e BSHS-B), con rilevamenti alle seguenti visite:
    o visita 3 (giorno dell’innesto);
    o visita 8 (90 +/- 5 giorni dopo l'innesto);
    o visita 9 (6 mesi +/- 10 giorni dopo l'innesto);
    o visita 11 (2 anni +/- 30 giorni dopo l'innesto);
    o visita 12 (3 anni +/- 30 giorni dopo l'innesto);
    E.5.2.1Timepoint(s) of evaluation of this end point
    See point E.5.2
    Rif. punto E.5.2
    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 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) 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 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 Yes
    E.8.1.7.1Other trial design description
    intra-patient randomised controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    autologous split-thickness skin
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Italy
    Netherlands
    Switzerland
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 10
    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: 3
    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: 4
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 2
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children < 12 years old.
    Bambini < 12 anni di etá.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 20
    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)
    None
    Nessuno
    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 Decision2020-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-11
    P. End of Trial
    P.End of Trial StatusOngoing
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