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    Summary
    EudraCT Number:2017-000361-78
    Sponsor's Protocol Code Number:HTA-HUR-01
    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:2020-10-22
    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 number2017-000361-78
    A.3Full title of the trial
    PROSPECTIVE, OPEN-LABEL, UNCONTROLLED CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF AUTOLOGOUS CULTURED ORAL MUCOSA GRAFTS FOR URETHRAL RECONSTRUCTION IN PATIENTS DUE TO HYPOSPADIAS TREATMENT FAILURE
    Studio clinico prospettico in aperto, non controllato, per la valutazione della sicurezza e dell'efficacia di lembi di mucosa orale autologhi coltivati per la ricostruzione dell'uretra di pazienti con esiti di fallimento del trattamento dell’ipospadia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial aiming to evaluate the safety and the efficacy of the urethral reconstruction starting from the stem cells of the oral mucosa of patients with treatment failure of hypospadias.
    Studio clinico con l'obiettivo di valutare la sicurezza e l'efficacia della ricostruzione dell'uretra partendo dalle cellule staminali della mucosa orale di pazienti con esiti di fallimento del trattamento dell’ipospadia.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberHTA-HUR-01
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorHOLOSTEM TERAPIE AVANZATE S.R.L.
    B.1.3.4CountryItaly
    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 supportHolostem Terapie Avanzate S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHolostem Terapie Avanzate S.r.l.
    B.5.2Functional name of contact pointFania Ferrari
    B.5.3 Address:
    B.5.3.1Street AddressVia Glauco Gottardi, 100
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41125
    B.5.3.4CountryItaly
    B.5.4Telephone number00390592058064
    B.5.5Fax number0000000
    B.5.6E-mailf.ferrari.consultant@holostem.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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameEx vivo expanded autologous human epithelial cells containing oral mucosa highly proliferative cells
    D.3.2Product code [Holour]
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Urethral reconstruction in patients due to hypospadias treatment failure.
    Ricostruzione dell'uretra in pazienti con esiti di fallimento del trattamento dell'ipospadia.
    E.1.1.1Medical condition in easily understood language
    Urethral reconstruction in patients due to hypospadias treatment failure.
    Ricostruzione dell'uretra in pazienti con esiti di fallimento del trattamento dell'ipospadia.
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Safety Objective:
    To demonstrate the safety of HOLOUR in terms of AESI (persisten fever, infections), ADRs, SAEs, Serious ADRs, at 3 months and one year after the treatment for urethral reconstruction in patients suffering from urethral reduced functionality due to hypospadias treatment failure.
    Primary Efficacy Objective:
    To evaluate the clinical success of the implantation of HOLOUR at one year after the treatment.
    Obiettivo primario di sicurezza:
    Dimostrare la sicurezza di HOLOUR in termini di AESI (febbre persistente, infezioni), ADR, SAE, ADR Gravi durante lo studio a 3 mesi e a un anno dopo il trattamento della ricostruzione dell’uretra in pazienti con esiti di fallimento del trattamento della ipospadia.
    Obiettivo Primario di Efficacia:
    Valutare il successo clinico dell’impianto di HOLOUR ad un anno dal trattamento.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    - To evaluate the efficacy of the treatment with HOLOUR and reconstruction
    - To evaluate the percentage of re-epithelialization;
    - To evaluate the clinical epithelial stability on the transplanted area;
    - To evaluate the presence of scar retraction;
    - To evaluate the uroflowmetry rate;
    - To evaluate the postvoid residual;
    - To evaluate the safety using the Clavien Dindo score for surgical complications;
    - To evaluate the safety at any time after the treatment.
    Obiettivi secondari
    - Valutare l’efficacia del trattamento con HOLUR e della ricostruzione;
    - Valutare la percentuale di riepitelizzazione;
    - Valutare clinicamente la stabilità epiteliale sulla area trapiantata;
    - Valutare l’assenza di retrazioni cicatriziali;
    - Valutare il tasso della uroflussometria;
    - Valutare il residuo post-minzionale;
    - Valutare la sicurezza usando la scala di Clavien Dindo per le complicanze;
    - Valutare la sicurezza in ogni momento dopo il trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all the following inclusion criteria to be eligible for enrolment into the study:
    1. Signed and dated informed consent prior to any study-related procedures (Caregivers); Patients whose parents/legal representatives have been thoroughly informed of the aim of the study procedures and provided signed and dated written informed consent
    2. Male patients between 5 and 17 years old (less than 18 years old);
    3. Need for urethroplasty in failed hypospadias treatment;
    4. Hypospadias complications shown by clinical evaluation, uroflowmetry with post-micturition residual evaluation and/or retrograde urethrography and/or urethroscopy;
    5. Uroflowmetry rate: Uroflowmetry with a plateau-shaped curve and low qmax according to paediatric uroflow nomograms;
    6. Absence of other contraindications to HOLOUR implantation based on investigator's judgment;
    7. A cooperative attitude to follow up the study procedures.
    I soggetti devono soddisfare tutti i seguenti criteri di inclusione per essere idonei all’arruolamento nello studio:
    1. Consenso Informato prima di qualsiasi procedura relativa allo studio (Tutori).
    Pazienti i cui genitori /rappresentanti legali siano stati completamente informati dello scopo delle procedure dello studio e abbiano firmato e datato il consenso informato scritto;
    2. Pazienti di sesso maschile (sia pediatrici che adolescenti) tra 5 e 17 anni di età (meno di 18 anni);
    3. Necessità di uretroplastica in falliti trattamenti per ipospadia;
    4. Complicanze di ipospadia evidenti ad esame clinico, uroflussometria con valutazione del residuo post-minzionale e/o uretrografia retrograda e/o uretroscopia;
    5. Tasso di Uroflussometria: Uroflussometria con curva a forma piatta e basso qmax in accordo a nomogramma di flusso pediatrico;
    6. Assenza di altre controindicazioni cliniche all’impianto di HOLOUR in base al giudizio dello Sperimentatore;
    7. Un atteggiamento cooperativo per seguire le procedure dello studio.
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a subject from study enrolment:
    1. Known or suspected intolerances against anaesthesia;
    2. Bad general condition (ECOG index >2);
    3. Clinical and/or laboratory signs of acute systemic infections and/or severe inflammation at the time of screening. Patient can be re-screened after appropriate treatment;
    4. Severe systemic disease (i.e. uncompensated diabetes);
    5. Stenosis or retraction secondary to medical conditions other than hypospadias failure (i.e. radiotherapy, lichen sclerosis, etc…);
    6. Allergy, sensitivity or intolerance to drugs or excipients (hypersensitivity to any of the excipients listed in Investigator's brochure or in this protocol):
    • Transport medium (Dulbecco’s Modified Eagles Medium supplemented with L-glutamine);
    • Fibrin support.
    7. Contraindications to the post- treatment local or systemic antibiotics and/or corticosteroids;
    8. UTI or urinoculture positive require a re-screening of patient;
    9. Contraindications to undergo extensive surgical procedures;
    10. Clinically significant or unstable concurrent disease or other clinical contraindications to stem cell implantation based upon investigator’s judgment or other concomitant medical conditions affecting grafting procedure;
    11. Patients and parents/tutor unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study procedures and treatments;
    12. Participation in another clinical trial where conventional investigational drug was received less than 1 months prior to screening visit;
    13. Patients who received surgical procedure within 6 months prior to screening visit;
    14. Anaesthesia or severe hypoesthesia of the area;
    15. Diagnosis of local or systemic neoplastic disease.
    Criteri di esclusione
    Presenza di uno qualsiasi dei seguenti criteri escluderà il soggetto dall’arruolamento nello studio:
    1. Note o sospette intolleranze all’anestesia;
    2. Cattive condizioni generali (indice ECOG>2);
    3. Segni clinici e/o di laboratorio di infezioni sistemiche e/o infiammazione grave al momento dello screening. Il paziente può essere selezionato nuovamente dopo appropriato trattamento;
    4. Gravi malattie sistemiche (i.e. diabete scompensato);
    5. Stenosi o retrazione secondaria ad altre condizioni diverse dal fallimento della ipospadia (i.e. radioterapia, sclerosi da lichen, etc.);
    6. Allergia, sensibilità o intolleranza a farmaci o eccipienti (ipersensibilità a qualsiasi eccipiente elencato nell’Investigator’s Brochure o in questo protocollo):
    o Mezzo di trasporto (Mezzo Eagles modificato di Dulbecco, integrato con L-glutammina);
    o Supporto con Fibrina;
    7. Controindicazioni a post-trattamento locale o sistemico con antibiotici e/o corticosteroidi;
    8. UTI o positività all’urinocoltura richiedono una rivalutazione del paziente;
    9. Controindicazioni ad essere sottoposto a lunghe procedure chirurgiche;
    10. Patologie concomitanti significative ed instabili o altre controindicazioni cliniche all’impianto di cellule staminali basate sul giudizio dello Sperimentatore o altre condizioni mediche concomitanti che possano pregiudicare la procedura di impianto;
    11. Pazienti e genitori/tutore difficilmente capaci di attenersi al protocollo clinico o incapaci di comprendere la natura e lo scopo dello studio o i possibili benefici o gli effetti indesiderati delle procedure e dei trattamenti dello studio;
    12. Partecipazione ad un altro studio clinico dove un farmaco di ricerca convenzionale sia stato ricevuto meno di un mese prima della visita di selezione;
    13. Paziente che è stato sottoposto a procedura chirurgica nella stessa area nei sei mesi precedenti alla visita di selezione;
    14. Anestesia o grave ipoestesia dell’area;
    15. Diagnosi di malattia neoplastica locale o sistemica.
    E.5 End points
    E.5.1Primary end point(s)
    Safety profile of the treatment with HOLOUR at 3 and 12 months after application (primary safety endpoint) will be described separately by age and summarized.
    AESIs, AEs, TEAEs and ADRs:
    • AEs will be coded by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA).
    • Incidence of AEs, AESIs, serious AEs, ADRs and serious, ADRs will be summarized both in terms of frequency of patients with at least one event and in term of frequency of events.
    • Persistent fever and infections will be notified as Adverse Events of Special Interest. The number and percentage of AESI (judged as related or unrelated) will be presented.
    • In addition, ADRs will be also stratified based on their relationship to the following:
    o Biopsy;
    o Implantation of HOLOUR;
    o Surgical reconstruction of penis;
    o Post-implantation pharmacological treatment with systemic and topical corticosteroids and antibiotics;
    o Cell-based product (HOLOUR).
    Vital signs and laboratory parameters
    • Vital signs (blood pressure, ECOG status, weight, temperature, pulse rate and respiratory rate) will be summarised as absolute and change from baseline values by means of descriptive statistics at each post-treatment study visit.
    • Haematology and blood chemistry parameters will be summarised as absolute and change from baseline to V12 (3 months) and V16 (12 months) values be means of descriptive statistics. Shift tables with regards to normal ranges will be provided as well.

    Efficacy variables
    Re-epithelialization and epithelium integrity:
    • Number and percentage of patients with successful implantation (primary efficacy endpoint) defined by degree of re-epithelialization and epithelium integrity will be summarized at each visit after engraftment of HOLOUR.
    Numerical score for the percentage of re-epithelialization expressed as judgement of a urologist, ranging from 0 to 100 and resuming the overall outcome of the treatment in terms of:
    1) Surface coverage extent of the self-regenerated epithelium on the lesion's site;
    2) Quality and stability of the epithelium engraftment.
    Il profilo di sicurezza del trattamento con HOLOUR a 3 e 12 mesi dopo la applicazione (end-point primario di sicurezza) sarà descritto per età e complessivamente:
    AESI, AE, TEAE e ADR:
    - AE saranno codificati mediante System Organ Class (SOC) e Preferred Term (PT) usando il Medical Dictionary for Regulatory Activities (MedDRA);
    - Incidenza di AE, AESI, AE gravi, ADR e ADR gravi saranno riepilogate sia in termini di frequenza di pazienti con almeno un evento sia in termini di frequenza di eventi.
    - Febbre persistente e infezioni saranno notificati come Eventi Avversi di Speciale Interesse. Il numero e la percentuale di AESI (giudicati come correlati o non correlati) verranno descritti.
    - In aggiunta, ADR verranno anche stratificati in base alla loro relazione con:
    • Biopsia;
    • Impianto di HOLOUR;
    • Ricostruzione chirurgica del pene;
    • Trattamento farmacologico sistemico e topico post- impianto con corticosteroidi e antibiotici;
    • Prodotto basato su cellule (HOLOUR).
    Segni Vitali e parametri di laboratorio
    - Segni vitali (pressione ematica, status ECOG, peso, temperatura, frequenza del polso e frequenza respiratoria) ad ogni visita successiva al trattamento in studio verranno riepilogati come assoluti e in relazione al cambiamento dai valori basali per mezzo di statistiche descrittive.
    - Parametri ematologici ed ematochimici verranno riepilogati come valori assoluti e al variare dal basale a V12 (3 mesi) e V16 (12 mesi) per mezzo di statistiche descrittive. Saranno forniti con tabelle con i valori di riferimento.

    Variabili di Efficacia
    Riepitelizzazione ed integrità dell’epitelio:
    - Numero e percentuale di pazienti trattati con successo (endpoint primario di efficacia) definiti dal grado di riepitelizzazione ed integrità dell’epitelio verrà riepilogato a ciascuna visita dopo trapianto di HOLOUR.
    Punteggio numerico della percentuale di riepitelizzazione espressa come giudizio di un urologo, variabile tra 0 e 100 e che riprende l’esito complessivo del trattamento in termini di:
    1. Copertura della superficie: estensione dell’epitelio auto-generato sulla sede di lesione;
    2. Qualità e stabilità del trapianto epiteliale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety profile of the treatment with HOLOUR at 3 and 12 months after application.
    Profilo di sicurezza del trattamento con HOLOUR a 3 e 12 mesi dopo la applicazione.
    E.5.2Secondary end point(s)
    NA
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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) 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 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 clinico prospettico in aperto, non controllato
    PROSPECTIVE, OPEN-LABEL, UNCONTROLLED CLINICAL 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 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 No
    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 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
    Last visit of the last patient after the last treatment.
    Ultima visita dell'ultimo paziente dopo l'ultimo trattamento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months15
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    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) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 No
    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
    Up to 8 adolescent and paediatric patients.
    Fino ad 8 pazienti pediatrici e adolescenti.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 8
    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)
    At the end of the study, all consenting patients will be asked to enter a safety and efficacy long-term follow-up period.
    Alla fine dello studio, i pazienti che acconsentiranno verranno inseriti in un periodo di follow-up a lungo termine di sicurezza ed efficacia.
    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 Decision2020-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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