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    Summary
    EudraCT Number:2018-004738-14
    Sponsor's Protocol Code Number:NanoGSkin-CB-2019
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-004738-14
    A.3Full title of the trial
    PHASE II CLINICAL TRIAL EVALUATING THE SAFETY AND EFFICACY OF A TISSUE ENGINEERED AUTOLOGOUS SKIN SUBSTITUTE RECONSTRUCTIVE SURGERY FOR BASAL CELL CARCINOMA.
    ENSAYO CLINICO FASE II PARA EVALUAR LA SEGURIDAD Y EFICACIA DE UN MODELO DE PIEL AUTÓLOGA CREADA MEDIANTE INGENIERÍA DE TEJIDOS EN LA CIRUGÍA RECONSTRUCTIVA DEL CARCINOMA BASOCELULAR.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of an artificial human skin medicine for patients with basal cell carcinoma undergoing reconstructive surgery.
    Estudio de un medicamento constituido por piel artificial humana en pacientes con carcinoma basocelular que van a someterse a cirugía reconstructiva.
    A.4.1Sponsor's protocol code numberNanoGSkin-CB-2019
    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 SponsorRed Andaluza de Diseño y Traslación de Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
    B.1.3.4CountrySpain
    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 supportInstituto de Salud Carlos III - Ministerio de Economía y Competitividad
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportFundación Pública Andaluza Progreso y Salud - Consejería de Salud y Familias
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRed Andaluza de Diseño y Traslación de Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
    B.5.2Functional name of contact pointClinical Trial Unit
    B.5.3 Address:
    B.5.3.1Street Addressc/ Algodón s/n (Esquina Avda. Hytasa)
    B.5.3.2Town/ citySeville
    B.5.3.3Post code41006
    B.5.3.4CountrySpain
    B.5.4Telephone number+3495504 83 66
    B.5.5Fax number+3495526 70 02
    B.5.6E-mailterapias.avanzadas@juntadeandalucia.es
    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 nameAdult autologous skin keratinocytes and fibroblasts expanded on fibrin-hialuronic biological matrix
    D.3.2Product code NanoGSkin
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Implantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEX-VIVO EXPANDED HUMAN AUTOLOGOUS FIBROBLASTS
    D.3.9.3Other descriptive nameEX-VIVO EXPANDED HUMAN AUTOLOGOUS FIBROBLASTS
    D.3.9.4EV Substance CodeSUB198917
    D.3.10 Strength
    D.3.10.1Concentration unit million CFU million colony forming units
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.5 to 3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEX-VIVO EXPANDED HUMAN AUTOLOGOUS KERATINOCYTES
    D.3.9.3Other descriptive nameEX-VIVO EXPANDED HUMAN AUTOLOGOUS KERATINOCYTES
    D.3.9.4EV Substance CodeSUB198916
    D.3.10 Strength
    D.3.10.1Concentration unit million CFU million colony forming units
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.5 to 3
    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.IMP: 2
    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 nameAdult autologous skin keratinocytes and fibroblasts expanded on fibrin-agarose biological matrix
    D.3.2Product code NanoGSkin
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Implantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEX-VIVO EXPANDED HUMAN AUTOLOGOUS FIBROBLASTS
    D.3.9.3Other descriptive nameEX-VIVO EXPANDED HUMAN AUTOLOGOUS FIBROBLASTS
    D.3.9.4EV Substance CodeSUB198917
    D.3.10 Strength
    D.3.10.1Concentration unit million CFU million colony forming units
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.5 to 3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEX-VIVO EXPANDED HUMAN AUTOLOGOUS KERATINOCYTES
    D.3.9.3Other descriptive nameEX-VIVO EXPANDED HUMAN AUTOLOGOUS KERATINOCYTES
    D.3.9.4EV Substance CodeSUB198916
    D.3.10 Strength
    D.3.10.1Concentration unit million CFU million colony forming units
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.5 to 3
    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
    Reconstructive skin surgery in basal cell cancer (Mohs surgery)
    Cirugía reconstructiva de piel en carcinoma basocelular (Cirugía de Mohs)
    E.1.1.1Medical condition in easily understood language
    Skin reconstruction surgery in patients with a type of skin cancer that involve basal cells.
    Cirugía de reconstrucción de la piel en pacientes con un tipo de cancer de piel que afecta las células basales.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10004146
    E.1.2Term Basal cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10064974
    E.1.2Term Mohs micrographic surgery
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the safety and effectiveness of autologous bioengineered skin in reconstructive surgery for basal cell carcinoma (Mohs surgery), in comparison with skin autografts and silicone dressings (Biobrane ®)
    Evaluar la seguridad y eficacia de piel autóloga obtenida mediante ingeniería de tejidos en la cirugía reconstructiva del carcinoma basocelular (cirugía de Mohs), en comparación con autoinjertos de piel y apósitos de silicona (Biobrane ®).
    E.2.2Secondary objectives of the trial
    - Clinical safety evaluation including any adverse events such as graft detachment, infections, necrosis, or other events.
    - Histological evaluation of the skin in the surgical injury.
    - Study of cutaneous homeostasis (pH, temperature, transepidermal water loss, elasticity) of the skin in the surgical injury.
    - Ultrasound study of the skin in the surgical injury.
    - Cost-effectiveness study of terapeutic alternatives evaluated in the trial (autologous skin substitute, autografts and biobrane).
    - Evaluación de seguridad analizando los posibles acontecimientos adversos, como el desprendimiento del injerto, la presencia de infecciones, necrosis u otros efectos.
    - Evaluación histológica de la lesión quirúrgica.
    - Estudio de la homeostasis cutánea (pH, temperatura, pérdida transepidérmica de agua, elasticidad) de la lesión quirúrgica.
    - Estudio mediante ecografía de la lesión quirúgica.
    - Estudio coste-efectividad de las alternativas de tratamiento evaluadas en el estudio (piel autóloga artificial, autoinjertos y biobrane).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients that give their informed consent for study participation.
    2. Adult (18 years of age or older), of any sex and racial origin.
    3. Clinical and dermatoscopic diagnosis of basal cell carcinoma with lesions on the scalp, torso or extremities, within a certain size that do not allow for surgical closure by direct suture or flaps. Namely, indication for Mohs surgery.
    4. Women with childbearing age or men capable of producing a child, should commmit to use contraceptives of medically proven efficacy.
    1.Firma del consentimiento informado.
    2.Pacientes adultos (de 18 años o más), de cualquier sexo y origen racial.
    3.Diagnóstico clínico y dermatoscópico de carcinoma basocelular con lesión en cuero cabelludo, tronco o extremidades de un tamaño no permita el cierre quirúrgico mediante sutura directa o colgajo. Indicación de tratamiento mediante cirugía de Mohs.
    4.Mujeres en edad fértil u hombres capaces de engendrar un hijo, deben aceptar el compromiso de utilizar métodos anticonceptivos de eficacia médicamente probada.
    E.4Principal exclusion criteria
    1. Locally advanced basal cell carcinoma with evidence of tissue infiltration.
    2. Lesions in the face.
    3. Injuries requiring urgent surgical intervention.
    4. Infected lesions, necrosis, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft.
    5. Injuries that have received treatment with radiotherapy.
    6. Contraindication for Mohs surgery.
    7. Known allergies to Biobrane dressing.
    8. Pregnant or breastfeeding women.
    9. Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up.
    10. Participation in other clinical trials in 3 months previous to inclusion,
    or in the previous 5 years for trials with advanced therapies.
    1. Carcinoma basocelular localmente avanzado con evidencias de infiltración de tejidos.
    2. Lesiones de localización facial.
    3. Lesiones que requieren una intervención quirúrgica urgente.
    4. Lesiones infectadas, necrosadas, escasamente vascularizadas u otras complicaciones que puedan condicionar la cicatrización y/o la integridad del injerto.
    5. Lesiones que han sido sometidas a tratamiento con radioterapia.
    6. Contraindicación para cirugía de Mohs.
    7. Alergias conocidas al apósito Biobrane.
    8. Embarazo o lactancia.
    9. Coexistencia de cualquier otra patología que, a criterio del investigador pueda comprometer el proceso de curación de la lesión o interfiera con el adecuado seguimiento programado en el protocolo.
    10. Pacientes que hayan participado en los 3 meses previos a la inclusión en otro ensayo clínico. Este periodo se prolongará hasta 5 años para ensayos clínicos con terapias avanzadas.
    E.5 End points
    E.5.1Primary end point(s)
    SAFETY ENDPOINTS: adverse events, including complications and sequelae in the healing of the surgical injury, as well as the severity of pain (analogical visual scale and use of analgesics). Both the surgical injury and the donor area (when applicable) will be taken into account in the evaluation.
    EFFICACY ENDPOINTS: clínical progress and time to complete epithelialization of the injury, time to removal of the suture, aesthetic quality of the lesion (POSAS questionnaire) and quality of life (DLQI). Efficacy variables will be measured both in the surgical lesion as well as in the donor area (when applicable).
    VARIABLES DE SEGURIDAD: acontecimientos adversos, incluidas las complicaciones y secuelas en la cicatrización de la lesión quirúrgica, así como la severidad del dolor (escala visual analógica y uso de analgésicos). En la evaluación se tendrá en cuenta tanto la lesión quirúrgica como la zona donante (cuando aplique).
    VARIABLES DE EFICACIA: evolución y tiempo hasta la completa epitelización de la lesión, tiempo hasta la retirada de la sutura, calidad estética de la lesión (cuestionario POSAS) y calidad de vida (DLQI). Las variables de eficacia se medirán tanto en la lesión quirúrgica como en la zona donante (cuando aplique).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and at day 5, 12, 30, 60, 90, 150, 210, 365, 548 and 730 after surgery, acording to the visits and assessments schedule of the trial protocol.
    Al inicio y a los 5, 12, 30, 60, 90, 150, 210, 365, 548 y 730 días tras la cirugía, conforme al calendario de visitas e evaluaciones del protocolo del estudio.
    E.5.2Secondary end point(s)
    Complementarily, a set of structural characteristics, molecular and functional properties of the skin will be measured in the surgical injury using different study techniques: doppler ultrasound, cutaneous homeostasis study, histological tests of skin biopsies using optical microscopy and immunohistochemical analysis.
    Complementariamente se medirán un conjunto de características estructurales, propiedades moleculares y funcionales de la piel en la lesión quirúrgica aplicando diferentes técnicas de estudio: ecografía doppler, estudio de homeostasis cutánea, estudio histológico de biopsias de piel mediante microscopía y análisis inmunohistoquímico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline and at day 5, 12, 30, 60, 90, 150, 210, 365, 548 and 730 after surgery, acording to the visits and assessments schedule of the trial protocol.
    Al inicio y a los 5, 12, 30, 60, 90, 150, 210, 365, 548 y 730 días tras la cirugía, conforme al calendario de visitas e evaluaciones del protocolo del estudio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) 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 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 Yes
    E.8.2.3.1Comparator description
    Autoinjerto de piel (intervención quirúrgica)
    Skin autografts (surgical intervention) / Biobrane (Medical device)
    E.8.2.4Number of treatment arms in the trial4
    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 concerned5
    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
    Last visit of the last patient included
    Última visita del último paciente incluido
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    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)
    No planned post trial treatment, as surgical injury is expected resolve without sequeale throughout trial follow-up.
    No se planifica ningún tratamiento post estudio, se espera que la lesión quirúrgica se resuelva sin secuelas durante el seguimiento.
    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 Decision2020-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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